RetinAI and PulseSight Therapeutics Expand Collaboration to Support Advancement of PST-611 Gene Therapy Program for Geographic Atrophy into Phase 2a

Bern, Switzerland - October 2nd, 2026 - Ikerian AG (parent company of RetinAI US Inc., “RetinAI”), developer of RetinAI Discovery®, an AI-powered multimodality data management platform for ophthalmology, and PulseSight Therapeutics SAS, an ophthalmology clinical stage biotech company developing disruptive non-viral vectorized gene therapies with minimally-invasive delivery technology, today announced an expanded collaboration to support the clinical development of PST-611, PulseSight's investigational gene therapy for geographic atrophy secondary to age-related macular degeneration. 

Following a post-hoc, exploratory OCT biomarker analysis of PulseSight's completed PST-611-CT1 Phase 1 trial using RetinAI’s AI-based technology, the two companies plan to continue working together as PulseSight advances PST-611 into a Phase 2a open-label multi-dose safety, tolerability and exploratory efficacy clinical trial in H2 2026.

PST-611-CT1 is an open-label, single ascending dose safety and tolerability trial of PST-611 in subjects with dry AMD. To support this program, PulseSight engaged RetinAI to conduct an exploratory, post-hoc analysis intended to inform the future clinical development of PST-611. RetinAI’s research team applied its CE-Marked, FDA-cleared RetinAI Discovery® platform and AI models to quantify structural changes and determine if early efficacy signals in the PST-611-CT1 OCT imaging dataset could be uncovered. 

Using RetinAI OCT Atlas®, a CE-marked model, as well as more advanced tools from the RetinAI suite, the post-hoc analysis uncovered pronounced early signals of efficacy by providing granular, longitudinal quantification of outer retinal layers and biomarkers such as RPE, ellipsoid zone (EZ), and myoid zone (MZ) loss across study and fellow eyes, before and after treatment initiation. This level of automated, per-eye, per-visit biomarker measurement would be difficult to efficiently achieve through manual grading alone, and is intended to help PulseSight characterize structural retinal dynamics as it advances to future clinical development.

"Understanding what is happening structurally in the retina, eye-by-eye, and visit-by-visit, is essential as we design and advance our Phase 2a program. RetinAI's analysis gave us a level of quantitative detail on our Phase 1 imaging data that has directly informed how we're approaching the next stage of PST-611's development" said George Weissgerber, Chief Medical Officer, at PulseSight Therapeutics.

"Early-stage trials generate rich imaging data that's often difficult to fully leverage with manual grading alone. Our work with PulseSight shows how AI-powered analysis can give clinical development teams a clearer, more granular view of structural change over time, right from Phase 1, to support better-informed trial designs and go/no-go decisions" said Dr. Carlos Ciller, Co-founder and CEO at RetinAI.

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Expanding the Collaboration into Phase 2a

RetinAI's research team conducted a retrospective exploratory analysis of the Phase 1 OCT imaging data, providing quantitative input that fed into the design of PulseSight's upcoming multi-dose PST-611 Phase 2a trial (additional details to be presented in a late-breaking oral presentation at 26th EURETINA Congress, on October 2nd, 2026) and contributes to shaping the development plans for PST-611. Building on this work, RetinAI Discovery® will support PulseSight's upcoming Phase 2a trial, including data collection, centralised image management and ongoing exploratory AI-based imaging analysis throughout the trial.

“Having RetinAI involved from Phase 1 through Phase 2a gives us continuity and speed in how we collect and interpret imaging data across our PST-611 clinical program. That consistency will be valuable as we move into a larger, multiple-dose trial”, said Judith Greciet, PharmD, Chief Executive Officer, at PulseSight Therapeutics.  

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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 4-month First-in-Human open-label trial 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.

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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).

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About Ikerian AG and RetinAI U.S. Inc.

Established in 2017, Ikerian AG (formerly RetinAI Medical AG) and its subsidiary, RetinAI U.S. Inc. (‘Ikerian’, ‘RetinAI’ and, together, ‘the companies’), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision. Focused on the ophthalmology and optometry market, RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI's international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases. A commercial stage company with growing sales from RetinAI Discovery®, RetinAI has established collaborations and partnerships with leading ophthalmology clinical networks and pharmaceutical companies. About Ikerian AG www.ikerian.com and RetinAI Inc. US www.retinai.com.

‍Disclaimer: RetinAI Discovery® and its AI modules for biomarkers, fluid, layer segmentation, as well as quantification in retinal pathologies, and Diabetic Retinopathy Screening model are CE-marked medical devices in accordance with the Medical Devices Regulation (EU) 2017/745 (CE2797). RetinAI Discovery® is also a medical device cleared for clinical use by the FDA. However, the AI modules for biomarkers, fluid, and layer segmentation and quantification in retinal pathologies are designated for Research Use Only (RUO) in the USA. Products intended for research use only are not medical devices.

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Media Contacts

Media Contact - Ikerian AG / RetinAI U.S. Inc.
Email: media@retinai.com

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