Eyestem’s Eyecyte-RPE™ Trial Shows Vision Rescue for Geographic Atrophy Patients

All nine subjects of Phase one injected without any Serious Adverse Events. Average improvement of 14.9 letters in visual acuity reported in the first 6 patients over a 4-6 month follow-up. Signs of disease reversal observed in some patients. Date: April 15, 2025 Eyestem Research, a Bangalore based cell therapy company, is excited to announce significant vision improvement in Phase 1 trials of its investigational drug product, Eyecyte-RPE™, in subjects with Geographic Atrophy (GA) secondary to Dry Age-Related Macular Degeneration (AMD). With all patient injections completed across three cohorts without any Serious Adverse Events (SAE), the first six patients had an average improvement of 14.9 letters in ETDRS standard vision tests within 4 to 6 months post-transplantation. Crucially, retinal imaging scans revealed early signs of disease reversal in a handful of patients, indicating a remarkable advancement in cell therapy in ophthalmology. Dr Jogin Desai, Founder and CEO, Eyestem, said, “The substantial vision improvement, sustained over a 4–6 month period in all six patients combined with an excellent safety profile has been very encouraging and has the potential to reshape the landscape of GA treatment globally. It is especially rewarding to see the improvement in the quality of life in these subjects. We look forward to exploring these early results further in our phase two study in India and the US." Eyecyte-RPE™ is a cryopreserved, allogeneic retinal pigment epithelium (RPE) cell suspension designed to replace damaged retinal cells and restore vision. The trial, after receiving approval from the Central Drug Standards Control Organization (CDSCO), was conducted across three reputed centres across India- AIIMS New Delhi, LV Prasad Eye Institute Hyderabad and Shri Ganpati Nethralaya, Jalna. Safety monitoring oversight was provided by an independent Drug Safety Monitoring Board comprising of global experts. In a joint statement, Dr. Gullapalli N. Rao, Founder of LV Prasad Eye Institute/Former President of the Academia Ophthalmologica Internationalis and Dr. Oppel Greeff, Former President, Global Clinical Development at Quintiles (now IQVIA) said “As some of the earliest backers of Eyestem we are delighted that this pioneering treatment is delivering remarkable outcomes. The results observed so far in Phase 1 not only demonstrate promising efficacy compared to other ongoing global trials but also validate India's potential as a leader in advanced cell therapy innovations. We are privileged to support a breakthrough that has the potential to redefine treatment outcomes for millions suffering from dry AMD.” Eyestem will be presenting its data at the ARVO 2025 Annual Meeting as well as the 10th Retinal Cell and Gene therapy Innovation Summit in early May. For more information, please visit: https://clinicaltrials.gov/study/NCT06394232 About Eyecyte-RPE™ Eyecyte-RPE™, derived from induced pluripotent stem cells (hiPSCs) is a proprietary retinal cell therapy product with a novel composition, developed and patented by Eyestem Research. The product can help replace the damaged or lost retinal pigment epithelial (RPE) cells and potentially enable tissue regeneration in the diseased retina. This unique formulation is allogeneic, scalable and can be stored as a frozen vial for long periods of time. About Geographic Atrophy Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration (AMD) that leads to progressive and irreversible loss of central vision, characterized by the death of cells in the macula, the central part of the retina. Approximately 196 million people suffer from Dry AMD globally, 5 million of whom suffer from GA. About Eyestem Research Headquartered in Bangalore and Delaware, Eyestem Research is a clinical-stage biotechnology company, which was started by a founding team with several decades of experience in pharmaceutical product development, retinal surgery, and cell biology. It has won significant accolades with the most recent one being named the top innovator in India across all sectors in 2022 by the prestigious The Economic Times newspaper. It is also the recipient of several prestigious grants and awards from the Department of Biotechnology (DBT), Government of India, and has been feted at high-profile government events as one of the most successful and innovative startups in the country.

The release as fetched from its publisher. eyestem.com ↗