Press release – Pulsesight

PulseSight presents PST-611 Phase I new early clinical efficacy data at EURETINA, offering a potential breakthrough approach to treat Dry AMD/Geographic Atrophy

Posted on October 7, 2026October 7, 2026 by edgover

Paris, France, October 7, 2026 – PulseSight Therapeutics SAS, an ophthalmology clinical-stage biotech company developing disruptive non-viral vectorized gene therapies with minimally invasive delivery technology, has presented further data from its PST-611 phase I clinical trial (CT1) in patients with advanced dry age-related macular degeneration (AMD), known as geographic atrophy (GA), in an oral presentation at the European Society of Retina Specialists’ 26th Euretina Congress, held 1-4 October 2026 in Vienna¹.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide, and GA remains a high unmet need as no treatments are approved in Europe for this condition.

The CT1 phase I trial was a first-in-human study aimed at evaluating the safety and tolerability of a single PST-611 administration. A total of six patients with advanced dry AMD/GA were treated with one dose of PST-611 in two successive cohorts at two escalating dose levels with a four-month follow-up. Previous results presented at ARVO in May 2026 demonstrated that PST-611-CT1 met the primary and secondary objectives, demonstrating excellent safety and tolerability at both dose levels.

Following spontaneous reports from study participants claiming a vision improvement after PST-611 administration and clinical observation of the OCTs showing a slowing of GA lesion growth dynamic, PulseSight performed a quantitative post hoc analysis using RetinAI Discovery ® platform and AI models to quantify structural changes in four OCT biomarkers of retina cell loss, before and after the administration of PST-611. The data were presented at Euretina, showing positive early signals of efficacy in five out of six treated patients.

In the full study population, all biomarkers, measured over the four-month period after treatment versus before, presented a consistent mean reduction of their growth rate ranging from 35 to 52%, supporting PST-611’s ability to protect and preserve RPE and photoreceptors in GA patients. Specifically, the mean RPE depletion growth rate dropped by 40% over the four-month period compared to before, a remarkable effect size in such an early onset.

The spontaneous, yet specific reports by the study participants of vision improvement in their daily activities, associated with the reduction in photoreceptors’ specific markers (ellipsoid zone (EZ) depletion rate (35%) as well as EZ thickness loss rate (52%)), are positive signs that PST-611 could also have the potential to preserve visual function.

PST-611 is a first-in-class therapy candidate encoding transferrin that plays a key role in the control of iron homeostasis. Dry AMD/GA is associated with a dysregulation of iron levels and oversaturation of transferrin. Through the expression of transferrin, PST-611 intervenes in a key upstream mechanism of GA pathogenesis and, thus, targets the multiple downstream biological cascades that drive the disease progression.

Presenting the results, PulseSight’s CMO George Weissgerber, MD, said, “We are thrilled by the positive outcome of our first-in-human study of PST-611. The study data demonstrate the excellent safety profile of PST-611, which is fundamental for patients, and this post hoc quantitative OCT biomarker analysis shows very promising signals of efficacy. Indeed, the effect size, the consistency of the results in the responding eyes, the improvement in structural biomarkers as well as reports of functional improvements and the early onset of effect, lasting over four months after a single administration are remarkable. These are very valuable insights as we initiate our phase 2 trial, which aims to confirm the safety and efficacy profile of PST-611.”

Prof Francine Behar Cohen, inventor of PulseSight’s technology and principal investigator at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), said, “The results from the study are very encouraging. It adds to the validation of PulseSight’s technology platform and supports the interest in targeting ferroptosis as a novel therapeutic approach in dry AMD and GA. PST-611 has shown an excellent safety profile and clear early efficacy signals in this first-in-human trial and I am very enthusiastic to be part of the next-stage clinical trials.”

Judith Greciet, PulseSight‘s CEO, added, “It is a very special moment for PulseSight, translating our research into human data and uncovering PST-611’s clinical profile. The CT1 study has confirmed the excellent safety profile and remarkable early efficacy signals. The long-lasting effect allows us to reduce treatments to 2-3 times a year, strongly improving patients’ compliance. We believe PST-611 has the potential to be a blockbuster, first-in-line treatment for GA, where a critical unmet patient need remains. We are eager to commence the phase IIa trial to further confirm these data in a larger cohort over a longer treatment period.”

The phase IIa trial (PST-611-CT2a) aims to assess PST-611’s safety and efficacy in up to 24 patients, after up to three administrations over 12 months. This trial is planned to start in H2 2026 with results available in 2028.

Oral presentation: Session 6 #138, Presenter: George Weissgerber, MD, Title: Transferrin in geographic atrophy patients using non-viral ocular gene therapy: safety, tolerability and early efficacy results from PST-611-CT1, a first-in-human trial, Date: 2 October 2026. See Abstract.

-ENDS-

Media contact

Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About Age-related Macular Degeneration (AMD)

AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD, also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 billion by 2031.

About PulseSight Therapeutics

PulseSight is a clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally invasive delivery technology for the treatment of retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-acting treatment for major eye diseases.

About PST-611 for GA

PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis, and holds the potential to effectively address key pathological mechanisms in dry AMD/GA.

Dry AMD involves the dysregulation of iron homeostasis, resulting in an excess of free iron.

Iron is crucial for proper cell function; however, excess free iron is highly toxic, inducing a Fenton reaction at the mitochondrial level, responsible for multiple toxic pathways, oxidative stress, lipid peroxidation and inflammation, ultimately leading to ferroptosis, a well-established cell death mechanism.

Transferrin is an endogenous protein playing a central role in the regulation of iron homeostasis.

Thanks to the innovative delivery technology, PST-611 expresses transferrin, which reaches the retina and restores normal free:bound iron balance, preventing the toxic cascade initiation upstream.

PST-611 has been shown to protect photoreceptors and retinal pigment epithelium (RPE) cells from death and to preserve visual function in animal models.

PulseSight is based in Paris, France, and its investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Watch the video of the technology here: www.PulseSightTherapeutics.com

EURETINA: PulseSight Therapeutics to Present Results of Phase 1 clinical trial of PST-611 treatment for dry AMD/Geographic Atrophy (GA)

Posted on September 16, 2026September 16, 2026 by edgover

Late Breaking Oral Presentation at 26th EURETINA Congress, 1-4 October 2026, Vienna

Paris, France, 16 September 2026 – PulseSight Therapeutics SAS, an ophthalmology clinical stage biotech company developing disruptive non-viral vectorized gene therapies with minimally-invasive delivery technology, will be presenting the results from its first-in-human, Phase 1 clinical trial of its lead clinical candidate PST-611 in a late breaking oral presentation at the European Society of Retina Specialists 26^th EURETINA Congress 1-4 October 2026 in Vienna.

A total of six patients were treated with one dose of PST-611 in two successive cohorts at two dose levels with a four-month follow-up. This first-in-human trial aimed to assessing safety and tolerability of PST-611 in patients with late stage dry Age-related Macular Degeneration (AMD)/Geographic Atrophy (GA). Results demonstrate that PST-611-CT1 met the primary and secondary objectives, with PST-611 demonstrating excellent safety and tolerability at both dose levels. In addition, pronounced early signals of efficacy, both functional and anatomical, have been observed in 5 out of the 6 patients treated, alongside spontaneous patient-reported improvement in their vision in daily life activities.

Presentation details

Oral presentation: Session 6 #138
Presenter: Georges Weissgerber, MD
Title: Transferrin in geographic atrophy patients using non-viral ocular gene therapy : safety, tolerability and early efficacy results from PST-611-CT1, a first-in-human trial
Timing: 2 October 2026, 13:05

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. Geographic Atrophy, the advanced form of dry AMD, remains a high unmet need as no treatments are approved in Europe for this condition.

-ENDS-

Media contact

Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About Age-related Macular Degeneration (AMD)
AMD is a progressive retinal disease associated with aging that affects approximately 200 million people globally. Dry AMD is the most common form and can progress to its late stage, geographic atrophy (GA). GA is characterized by enlarging, irreversible atrophic lesions driven by retinal cell degeneration, ultimately leading to permanent central vision loss in many patients. GA affects approximately 1 million people in the United States, more than 1.5 million in Europe, and over 5 million worldwide. It represents a major unmet medical need, with a profound impact on quality of life, including the ability to read, recognize faces, drive, and perform daily activities. Overall, AMD remains a significant unmet need for more effective and durable treatment options, with a large and growing market estimated to reach $27.5 billion by 2031.

About PST-611 for GA
PST-611 encodes the human transferrin protein, a key regulator of iron homeostasis, and has the potential to target the underlying disease biology involved in dry AMD and geographic atrophy (GA). Dry AMD is associated with dysregulation of iron homeostasis, resulting in excess free iron in retinal tissues. While iron is essential for normal cellular function, excess free iron is highly toxic and contributes to oxidative stress, lipid peroxidation, inflammation, and ferroptosis, a well-established mechanism of programmed cell death.

Transferrin is an endogenous protein that plays a central role in regulating iron balance. Using PulseSight’s innovative delivery technology, PST-611 expresses transferrin, restoring iron balance thus preventing initiation of downstream toxic pathways.

PST-611 has completed a 12-month First-in-Human open-label study demonstrating excellent safety and tolerability, with encouraging signals of early efficacy both functional, with spontaneous patient feedback of vision improvements, and anatomical. Earlier preclinical studies of PST-611 have demonstrated protection of photoreceptors and retinal pigment epithelium (RPE) cells and preservation of visual function in animal models.

About PulseSight Therapeutics
PulseSight is a clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally invasive delivery technology for the treatment of retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Already clinically validated for its safety, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-acting treatment for major eye diseases.

Based in Paris, France, PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Watch the video of the technology here: https://pulsesight.com/technology/

Positive Results from PulseSight’s Phase I Clinical Trial of PST-611 in Dry AMD/Geographic Atrophy Presented at ARVO 2026

Posted on May 11, 2026 by edgover

Paris, France, May 11, 2026 – PulseSight Therapeutics SAS, an ophthalmology clinical stage biotech company developing disruptive non-viral vectorized gene therapies with minimally-invasive delivery technology, has reported the results of its PST-611 Phase 1 clinical trial (PST-611-CT1), in patients with late-stage dry Age-related Macular Degeneration (AMD) called Geographic Atrophy (GA), in a podium presentation at the ARVO 2026 Annual Meeting.

GA is a multifactorial disease involving a dysregulation of iron homeostasis. PST-611 is a first-in-class gene therapy candidate encoding transferrin, a natural iron transporter playing a key role in iron homeostasis.

PST-611-CT1 is a single ascending dose first-in-human trial that evaluated the safety and tolerability of two dose levels (low and high) of PST-611 in two successive dose groups, in a total of six patients, with a 16-week follow-up.

The trial was conducted in Paris and Grenoble by Professor Francine Behar-Cohen MD, PhD, lead investigator at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP) and Professor Christophe Chiquet, MD, PhD, at the Department of Ophthalmology, CHU Grenoble Alpes.

PST-611-CT1 met the primary and secondary objectives, with PST-611 demonstrating excellent safety and tolerability at both dose levels. Most reported ocular adverse events were mild, with two assessed as moderate. There were no observations of intraocular inflammation, and no treatment emergent serious adverse events (SAE) or suspected unexpected serious adverse reactions (SUSAR) were reported. The Best Corrected Visual Acuity (BCVA) was stable over the entire follow-up period.

Even though the study was not designed to assess efficacy, encouraging signals of early efficacy were observed, both functional, with spontaneous patient feedback of vision improvements, and anatomical, with associated inflections of the GA lesion growth. In one case the observed efficacy signal lasted beyond the trial follow-up period.

Based on these positive outcomes, PulseSight plans to start a repeat dose Phase 2a clinical trial to assess the safety and explore the efficacy of three administrations of PST-611 (high dose) over 52 weeks.

Presenting the results, Professor Francine Behar-Cohen said, “Geographic atrophy is a progressive, sight-threatening disease with no effective treatment currently available in Europe— the unmet medical need is real and urgent. These Phase 1 results are therefore particularly meaningful. PST-611 demonstrated excellent tolerability, which is fundamental when treating patients with a chronic condition. What makes these results stand out are the early efficacy signals we observed, both anatomically and functionally. I look forward to the Phase 2a trial, which will allow us to confirm the therapeutic potential of PST-611 over a longer follow-up and in a larger group of patients.”

Judith Greciet, PulseSight‘s Chief Executive Officer, said, “We are thrilled by the outcome of our first-in-human study of PST-611. The trial met its primary objective with an excellent safety profile and went beyond our expectations: we observed early functional and anatomical efficacy signals, notably spontaneous reports from several participants of noteworthy vision improvements — after a single dose and just four months of follow-up. This is a highly encouraging result for a Phase 1 trial, and a significant milestone for the company. We are now advancing PST-611 into a Phase 2a trial, currently under regulatory review, with enrolment expected to begin after the summer.”

PulseSight has submitted a Clinical Trial Authorization (CTA) application to the French regulatory authority, Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), of a repeat dose, 52-week, Phase 2a trial (PST-611-CT2) designed to assess the safety and explore the efficacy of three administrations of PST-611 in up to 20 patients, in 3 clinical trial sites. Subject to CTA approval, the trial is anticipated to begin in H2 2026, with results expected in 2028.

Professor Francine Behar-Cohen

-ENDS-

Media contact

Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About Age-related Macular Degeneration (AMD)
Age-related macular degeneration (AMD) is a progressive retinal disease associated with aging that affects approximately 200 million people globally. Dry AMD is the most common form and can progress to its late stage, geographic atrophy (GA). GA is characterized by enlarging, irreversible atrophic lesions driven by retinal cell degeneration, ultimately leading to permanent central vision loss in many patients. GA affects approximately 1 million people in the United States, more than 1.5 million in Europe, and over 5 million worldwide. It represents a major unmet medical need, with a profound impact on quality of life, including the ability to read, recognize faces, drive, and perform daily activities. Overall, AMD remains a significant unmet need for more effective and durable treatment options, with a large and growing market estimated to reach $27.5 billion by 2031.

About PST-611 for GA

Dry AMD is associated with dysregulation of iron homeostasis, resulting in excess free iron in retinal tissues. While iron is essential for normal cellular function, excess free iron is highly toxic and contributes to oxidative stress, lipid peroxidation, inflammation, and ferroptosis, a well-established mechanism of programmed cell death.

Transferrin is an endogenous protein that plays a central role in regulating iron balance. Using PulseSight’s innovative delivery technology, PST-611 is designed to deliver transferrin to the retina to restore physiological iron balance and prevent initiation of downstream toxic pathways.

In preclinical studies, PST-611 demonstrated protection of photoreceptors and retinal pigment epithelium (RPE) cells and preservation of visual function in animal models.

Based in Paris, France, PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Watch the video of the technology here: https://pulsesight.com/technology/

Last patient, last visit completed in Phase I clinical trial of PulseSight Therapeutics’ PST-611 treatment for dry AMD/Geographic Atrophy (GA)

Posted on April 23, 2026April 23, 2026 by edgover

Results to be presented at ARVO 2026 Annual Meeting

Paris, France, April 23, 2026 – PulseSight Therapeutics SAS, an ophthalmology clinical stage biotech company developing disruptive vectorized gene therapies with minimally-invasive delivery technology, will be presenting the results of its PST-611 phase I clinical trial at the ARVO 2026 Annual Meeting May 3-7 in Denver, Colorado.

With the follow up of the last patient treated completed, the company is preparing trial read out for presentation at the 2026 ARVO Annual Meeting by Professor Behar-Cohen, MD, PhD, lead investigator at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP).

A total of six patients were treated with PST-611 in two successive cohorts at two dose levels over the past year in a phase I trial to assess its safety and tolerability, as non-viral vectorized therapy for dry Age-related Macular Degeneration (AMD)/Geographic Atrophy (GA). The study was conducted in Paris and Grenoble by Professor Francine Behar-Cohen and Professor Christophe Chiquet, MD, PhD, at the Department of Ophthalmology, CHU Grenoble Alpes.

Presentation details

Presenter: Professor Behar-Cohen
Abstract/Presentation Title/Number: Transferrin in geographic atrophy patients using non-viral ocular gene therapy : Results from PST-611-CT1, a First-in-Human trial – #5926
Session Title/Timing/Number: Diabetic retinopathy and related disorders – #546
Session Timing/Location: May 7, 2026, 14:00 -15:45, Room – Mile High 1C
Presentation Timing: 15:30 – 15:45

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. Geographic Atrophy, the advanced form of dry AMD, remains a high unmet need for efficient and well tolerated treatment that prevents disease progression.

PST-611 is a first-in-class candidate, expressing transferrin, a natural iron transporter playing a key role in the control of normal iron homeostasis. Dry AMD involves the dysregulation of iron homeostasis, leading to an excess of free iron causing highly toxic effects such as inflammation, oxidative stress, and ultimately retinal cell death (ferroptosis). PST-611 has been shown to protect photoreceptors and retinal pigment epithelium (RPE) cells from death and to preserve visual function in animal models.

George Weissgerber, MD, PulseSight‘s Chief Medical Officer, said, “Presentation of the results of our first in human clinical trial of PST-611 at a major ophthalmology conference is a significant milestone for the company. The progress made over the past year is very encouraging for the project and for patients. We will be building upon this trial in the planned phase IIa study to further demonstrate PST-611’s potential for the treatment of AMD/GA patients.”

-ENDS-

Media contact

Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About Age-related Macular Degeneration (AMD)
AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and is ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA. Results from a phase 1 trial of PST-611 will be presented at ARVO 2026.

Based in Paris, France, PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Watch the video of the technology here: https://pulsesight.com/technology/

Dosing completed in the Phase I clinical trial of PulseSight Therapeutics’ PST-611 treatment for dry AMD/Geographic Atrophy (GA)

Posted on January 22, 2026January 21, 2026 by edgover

Paris, France, January 22, 2026 – PulseSight Therapeutics SAS, an ophthalmology clinical stage biotech company developing disruptive vectorized gene therapies with minimally-invasive delivery technology, is pleased to announce the completion of PST-611 phase I clinical trial enrolment. Trial data will be presented at the 2026 ARVO Annual Meeting May 3-7.

PST-611’s phase I trial assesses its safety and tolerability in dry Age-related Macular Degeneration (AMD)/Geographic Atrophy (GA) patients. As per plan, six patients have been treated in two successive cohorts at two dose levels.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. Geographic Atrophy, the advanced form of dry AMD, remains a high unmet need for efficient and well tolerated treatment that prevents disease progression

The PST-611 phase I study is being conducted in Paris and Grenoble by Professor Francine Behar-Cohen, MD, PhD, at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP) and Professor Christophe Chiquet, MD, PhD, at the Department of Ophthalmology, CHU Grenoble Alpes.

Professor Francine Behar-Cohen said, “Having pioneered the development of the electro-transfection technology that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye, I am very enthusiastic about PST-611 and very pleased to support the clinical development of this promising candidate. Late-stage dry AMD/ GA is a progressing disease that leads to vision loss and for which we have no therapeutic options for our patients. Based on its mechanism of action and thanks to the innovative delivery technology, PST-611 has potential to become a major treatment option for these patients.”

George Weissgerber, MD, PulseSight‘s Chief Medical Officer, said, “We are very pleased to have completed the enrolment of the patients in the phase I trial and thankful to our investigators and their team for their involvement and support in the recruitment and treatment of the patients. This trial marks the first step of PST-611 clinical development and provides the foundation to build upon for the phase IIa trial we are already preparing to further demonstrate PST-611’s potential.”

-ENDS-

Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About Age-related Macular Degeneration (AMD)

AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and is ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PST-611 for GA

PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. Results from a Phase 1 study of PST-611 are expected in [Q1] 2026.

About PulseSight Therapeutics

PulseSight is a clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

Based in Paris, France, PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Watch the video of the technology here: www.PulseSightTherapeutics.com

Peer Reviewed Publication Provides Evidence for Iron Dysregulation as a Driver of Dry AMD/GA and the Potential of Transferrin to Restore Iron Balance, Reinforcing PulseSight’s Therapeutic Strategy for PST-611

Posted on October 14, 2025October 14, 2025 by edgover

Paris, France, 14 October 2025 – PulseSight Therapeutics, a clinical stage ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology welcomes the publication of new data reinforcing interest in transferrin (Tf) as a drug candidate for the treatment of dry age-related macular degeneration (AMD), in a study performed by scientists from Inserm and Cochin Hospital in Paris, in collaboration with PulseSight’s scientists.

Dysregulation of iron homeostasis plays a crucial role in retinal diseases, contributing to oxidative stress, inflammation, and ferroptosis, key processes that drive the degeneration of the retinal pigment epithelium (RPE) and photoreceptors and the progression from dry AMD to Geographic Atrophy (GA). Tf, an endogenous glycoprotein, regulates iron homeostasis by binding and transporting iron in a non-toxic form, preventing harmful accumulation.

The study sought to provide mechanistic insights into the role of iron dysregulation into dry AMD/Geographic Atrophy (GA) and how transferrin could prevent ferroptosis, a form of iron-dependent cell death increasingly recognized as a key contributor to AMD pathology.

The peer-reviewed publication this week in Nature Publishing Cell Death & Disease(1) provides compelling support for the hypothesis that iron dysregulation is not merely a bystander, but a potential driver of dry AMD, especially in the early geographic atrophy (GA) stage

These clinical data confirm PulseSight’s therapeutic strategy in developing PST-611, an innovative first-in-class non-viral vectorized therapy that delivers a plasmid encoding transferrin into the eye with the aim of restoring iron balance and preserve retinal structure and function in dry AMD/GA. Now well progressed in a phase I clinical trial, results are expected by early 2026.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex, and the disease still represents a high unmet need.

Study detail

The scientists explored iron-transferrin imbalance in one of the largest aqueous humor datasets to date from dry AMD/GA patients and age-matched controls patients. The study confirmed elevated iron levels and increased transferrin saturation in aqueous humors of AMD patients, providing clinical confirmation of iron dysregulation in the disease.

In addition, the team conducted complementary in vitro experiments demonstrating that, in human RPE cells, iron overload triggered oxidative stress, mitochondrial damage, inflammation, complement activation, and ferroptosis – key hallmarks of AMD. Similarly, exposure of RPE cells to oxidized lipids induced similar changes in iron homeostasis and downstream cascades.

In these stressed conditions, TF supplementation restored iron balance and significantly reduced oxidative and inflammatory damage in RPE cells, preserving the integrity of the epithelial structure and further reinforcing the therapeutic relevance of iron modulation in GA — still an underexplored treatment avenue.

Welcoming these new insights, Professor Joshua Dunaief, University of Pennsylvania, an expert and pioneer in proposing iron involvement in retinal degeneration, and member of PulseSight’s Scientific Advisory Board said: “Over the past years, growing evidence has pointed to iron as an important contributor to retinal degeneration in dry AMD. Iron can promote oxidative damage and inflammation, both of which are central in disease progression. I am very enthusiastic to see programs such as PST-611, based on this approach, entering clinic, and demonstrate the value of this target for treatments that could preserve vision and improve patients’ lives.”

Thierry Bordet Ph.D., CSO/COO of PulseSight Therapeutics added, “I congratulate my colleagues on this important publication. It confirms the role of ferroptosis in AMD/GA, the critical importance of restoring iron homeostasis, and the protective potential of transferrin in this highly disabling disease. At PulseSight, we’ve designed a unique translational strategy to restore iron homeostasis and prevent ferroptosis. With PST-611, we combine mechanistic relevance, long-lasting efficacy, and a de-risked delivery platform positioning PST-611 as a potential major option for patients with dry AMD/GA.”

Youale et al., “Transferrin is a drug candidate for the treatment of dry age-related macular degeneration (AMD),” Cell Death & Dis, 16, 692 (2025). PMID: 41053100

-ENDS-

Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About age-related macular degeneration (AMD)
AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and is ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program entered a Phase I clinical trial (PST-611-CT1) in France in 2025.

About PulseSight Therapeutics
PulseSight is clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).
For more information visit www.PulseSightTherapeutics.com

PulseSight Therapeutics Provides New Insights into the Role of Iron and Transferrin in AMD, Supporting its PST-611 Vectorized Therapy for Dry AMD/Geographic Atrophy at EURETINA 2025

Posted on September 4, 2025September 4, 2025 by edgover

Paris, France, 4 September 2025 – PulseSight Therapeutics, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology announces that its CSO, Thierry Bordet Ph.D., will present new data on iron dysregulation and ferroptosis role in age related macular degeneration (AMD) during an oral presentation at 25th EURETINA Congress1, the major ophthalmology conference being held in Paris this week.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex, and the disease still represents a high unmet need. Growing evidence identifies iron overload as a key factor in AMD by promoting oxidative stress, inflammation, and ferroptosis, driving progression from dry AMD to geographic atrophy (GA). Transferrin, an endogenous glycoprotein, regulates iron homeostasis by binding and transporting iron in a non-toxic form, preventing harmful accumulation.

In collaboration with Inserm and Cochin Hospital (Paris), PulseSight explored iron-transferrin imbalance in one of the largest aqueous humor datasets to date from dry AMD/GA patients and age-matched controls patients. The study confirmed elevated iron and increased transferrin saturation in in aqueous humors of AMD patients, providing clinical confirmation of iron dysregulation in the disease and reinforcing the therapeutic relevance of iron modulation in GA — still an underexplored treatment avenue.

Dr Bordet will also present topline data from a specific study conducted to provide mechanistic insights into the role of transferrin to prevent ferroptosis, a form of iron-dependent cell death increasingly recognized as a key contributor to AMD pathology. Full results of this study have been submitted for peer-reviewed publication.

These findings further support the development of PulseSight’s lead therapy, PST-611, a first-in-class non-viral vectorized therapy encoding transferrin to restore iron balance and preserve retinal structure and function in dry AMD/ GA. PST-611 entered a phase I clinical trial (PST-611-CT1) earlier this year.

Thierry Bordet Ph.D., CSO of PulseSight Therapeutics said, “Ferroptosis is now a well-recognized target in AMD pathology. At PulseSight, we’ve designed a translational strategy to restore iron homeostasis and prevent ferroptosis. With PST-611, we combine mechanistic relevance, long-lasting efficacy, and a de-risked delivery platform. We’re excited to advance this first-in-class therapy for patients with dry AMD/GA.”

1. EURETINA 2025, Abstract Number: RETINA25-1768. 5 September 13:06 – 13:12
Vectorized Transferrin as a Novel Therapeutic Strategy for Dry Age-related Macular Degeneration/Geographic Atrophy: Preclinical and Clinical Speakers.

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Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program is expected to enter the clinic by late summer 2025.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).
For more information visit www.PulseSightTherapeutics.com

First patient dosed in the Phase I clinical trial of PulseSight Therapeutics’ PST-611 treatment for dry AMD/Geographic Atrophy

Posted on July 7, 2025July 7, 2025 by edgover

Paris, France, July 7^th, 2025 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce that the first patient has been successfully dosed in its Phase I clinical trial (PST-611-CT1) aiming to assess safety and tolerability of its lead program, PST-611, in humans.

PST-611 is a first-in-class non-viral vectorized therapy for the treatment of dry Age-related Macular Degeneration (AMD) /Geographic Atrophy (GA), expressing human transferrin, a highly potent iron regulator, playing a central role in restoring normal iron homeostasis.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex, and the disease still represents a high unmet medical need. Dry AMD involves the dysregulation of iron homeostasis, leading to an excess of free iron causing highly toxic effects such as inflammation, oxidative stress, and ultimately retinal cell death (ferroptosis).

PST-611-CT1 is a first-in-human single ascending dose study that aims to establish, in six to a maximum of 12 dry AMD/GA patients, the safety profile of the drug and validate the maximal tolerated dose in view of the following Phase IIa proof-of-concept trial. Preliminary results are anticipated early 2026, subject to patient recruitment.

The study is being conducted in Paris and Grenoble by Professor Francine Behar-Cohen, MD, PhD at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), the inventor of our technology, and Professor Christophe Chiquet, MD, PhD at the Department of Ophthalmology, CHU Grenoble Alpes.

Professor Francine Behar-Cohen declared, “Having pioneered the development of the electro-transfection technology that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye, I am very excited to move PST-611, expressing transferrin, into its first clinical trial. Late-stage dry AMD/ GA is a progressing disease that leads to vision loss and for which we have no therapeutic options for our patients. Based on its mechanism of action and thanks to the innovative delivery technology, PST-611 has potential to become a major treatment option for these patients.”

Judith Greciet, CEO of PulseSight Therapeutics said, “The dosing of the first patient in our PST-611-CT1 trial is a very exciting milestone for the company. Supported by the previous clinical demonstration of the safety profile of our innovative delivery technology and a solid pre-clinical package, we believe PST-611 holds the potential to improve both anatomical and functional features of dry AMD/GA. Moreover, the sustained and long-lasting expression of transferrin should help reduce the need for frequent reinjections, strongly improving patients’ compliance to the treatment. Once the safety and the maximal dose are confirmed, our goal is to swiftly move into a phase IIa proof-of-concept study, to demonstrate the ability of transferrin to protect retinal cells from atrophy and preserve vision.”

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Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About age-related macular degeneration (AMD)

AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and is ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program is expected to enter the clinic by late summer 2025.

About PulseSight Therapeutics

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

Watch the video of the technology here: www.PulseSightTherapeutics.com

PulseSight Therapeutics receives CTA approval from ANSM for Phase I trial in France of PST-611, Transferrin Vectorized Therapy for dry AMD/Geographic Atrophy

Posted on June 2, 2025June 2, 2025 by edgover

Paris, France, 2 June 2025 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce it has received the Clinical Trial Authorization (CTA) from the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for a Phase I trial (PST-611-CT1) assessing PST-611 safety and tolerability in human.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex, and the disease still represents a high unmet need. Dry AMD involves the dysregulation of iron homeostasis, leading to an excess of free iron causing highly toxic effects such as inflammation, oxidative stress, and ultimately retinal cells death.

PST-611 is a first-in-class non-viral vectorized therapy for the treatment of dry AMD/ GA, expressing human transferrin, a highly potent iron regulator, playing a central role to restore normal iron homeostasis.

PST-611-CT1 is a first-in-human single ascending dose trial aiming to confirm the favorable safety profile of the drug and validate the maximal dose for the Phase II proof-of-concept study, in six to a maximum of twelve dry age-related macular degeneration (AMD)/geographic atrophy (GA) patients.

The study will be conducted in Paris and Grenoble by Professor @Francine Behar-Cohen, MD, PhD at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), the inventor of our technology, and Professor Christophe Chiquet, MD, PhD at the Department of Ophthalmogy, CHU Grenoble Alpes. It is expected to start later in the summer with a readout anticipated early 2026.

The PST-611-CT1 Phase I trial builds on PulseSight’s previous clinical demonstration of the favorable safety profile of its innovative delivery technology and benefits from a solid preclinical package demonstrating its potential to address both anatomical and functional features of Dry AMD/GA. Moreover, the sustained and long-lasting expression of transferrin should help reduce the need for frequent reinjections, strongly improving patients’ compliance to the treatment.

Judith Greciet, CEO of PulseSight Therapeutics said, “Congratulations to our team and consultants for their excellent work to reach this first milestone to bring PST-611 to patients. We believe PST-611 holds the potential to become a major new treatment option for patients with dry AMD/GA. Our goal is to confirm the safety and the optimal dose of our drug candidate to then rapidly move into a phase II proof-of-concept study, to demonstrate transferrin’s ability to protect retinal cells from atrophy and preserve vision.”

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Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program is expected to enter the clinic by late summer 2025.

About PulseSight Therapeutics

PulseSight is clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

PulseSight Therapeutics Announces First Close of its Series A Financing to Fund Clinical Development of PST-611 in dry AMD

Posted on February 13, 2025 by edgover

Paris, France, 13 February 2025 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, today announces the first close of its Series A financing with existing investor Pureos BioVentures committing new funds to support the Phase I study of PST-611 and enable preparation for a Phase IIa clinical trial.

PST-611 is a first in class non-viral vectorized therapy for the treatment of dry age-related macular degeneration (AMD)/geographic atrophy (GA), expressing human transferrin, a highly potent iron regulator. Restoring normal iron homeostasis, transferrin has demonstrated strong beneficial effects in preclinical models, reducing oxidative stress and inflammation, and preserving the integrity of the retinal pigment epithelium, with the potential of preventing retinal degeneration and vision loss.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex and involves the dysregulation of iron homeostasis, leading to an excess of free iron, which results in inflammation, oxidative stress, and cell death.

PulseSight has already demonstrated the favorable safety profile of its innovative technology as well as biological activity in the clinic, with a previous clinical program in non-infectious uveitis.

The planned PST-611-CT1 clinical trial aims at primarily confirming the favorable safety profile of PST-611 administration and is expected to start Q2 2025, subject to the regulatory greenlight, with readout anticipated end 2025/early 2026.

The Series A financing remains open to new investors, to provide funds to support PST-611 Phase IIa clinical trial preparation and implementation, as well as the development of PulseSight’s wider portfolio of non-viral vectorized therapies including PST-809, a potential first-in-class therapy for wet AMD that comprises a dual-gene plasmid encoding for a potent anti-VEGF, together with decorin, an anti-angiogenic and anti-fibrotic native protein. Wet AMD is a complex disease involving many pathological pathways which lead to progressive vision loss and there remains a significant unmet need.

Dominik Escher, board director of PulseSight and Partner at Pureos Bioventures said, “Pureos is delighted to continue its support of PulseSight, to enable it to advance what we believe could be truly life-changing treatments for patients with diseases leading to sight loss. PST-611 is developed in GA, a blinding disease with no treatments approved in Europe. PST-611 has a completely new mode of action with the potential to stop the progression of the disease, a truly high unmet medical need. PulseSight has the innovation and expertise to become a highly valuable company in the field of non-viral gene therapy in ophthalmology.”

Judith Greciet, CEO of PulseSight Therapeutics said, “We are excited to have the funds to progress our lead program, PST-611, which we believe holds the potential to become a major new treatment option for patients with dry AMD/GA. This financing enables us to execute on our goal of confirming the safety of our drug candidate and to then rapidly move into a phase II proof-of-concept study, to demonstrate transferrin’s ability to protect retinal cells and preserve vision.”

Dirk Sauer, Chairman of the Board of PulseSight Therapeutics said, “I congratulate Judith and the team who have advanced PST-611 at pace during 2024 and welcome the continued support of Pureos BioVentures to advance our lead candidate. There remains an unaddressed need for non-viral approaches that would unlock the full potential of gene therapies. I am encouraged by the data behind PulseSight’s approach and its therapies, and I look forward to welcoming other investors to the syndicate to enable us to further validate PulseSight’s disruptive potential through clinical studies.”

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Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program is expected to enter the clinic by Q2 2025.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

ILife Consulting is a Paris-based CRO dedicated to providing tailored consultancy and CRO services to biotechs. contact@ilifeconsulting.com