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

PARIS, May 11, 2026 (GLOBE NEWSWIRE) -- 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.

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Sue Charles, Charles Consultants

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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 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 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 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: www.PulseSightTherapeutics.com

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