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

• All nine subjects of Phase 1 injected without any serious adverse events.
• Average improvement of 14.9 letters in visual acuity reported in the first six patients over a four-six month follow-up.
• Signs of disease reversal observed in some patients.

Eyestem Research, a Bangalore-based cell therapy company, is pleased to announce significant vision improvement in Phase 1 trials of its investigational drug, Eyecyte-RPE™, in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). All patients across three cohorts were dosed without any serious adverse events. The first six showed an average 14.9-letter gain in ETDRS vision tests within 4–6 months, with early signs of disease reversal seen in some retinal scans—marking an advance in ophthalmic cell therapy.

Dr Jogin Desai, Founder and CEO, Eyestem, said, “The vision improvement, sustained over a four–six month period in all patients combined with an excellent safety profile has been encouraging and has the potential to reshape the GA treatments globally. It is rewarding to see the improvement in the quality of life in these patients. We look forward to exploring these early results in our phase two study in India and the US."

Eyecyte-RPE™ is a cryopreserved, allogeneic RPE cell suspension developed to replace damaged retinal cells and restore vision. Approved by CDSCO, the Phase 1 trial was conducted at AIIMS New Delhi, LV Prasad Eye Institute Hyderabad, and Shri Ganpati Nethralaya, Jalna, with oversight from an independent global safety board.

In a joint statement, Dr Gullapalli N Rao, Founder, LV Prasad Eye Institute and Former President, Academia Ophthalmologica Internationalis and Dr Oppel Greeff, Former President, Global Clinical Development, Quintiles (now IQVIA) said, “As some of the earliest backers of Eyestem, we are delighted that this treatment is delivering remarkable outcomes. The results observed in Phase 1 demonstrate promising efficacy compared to other ongoing global trials and validate India's potential as a leader in advanced cell therapy innovations. We are privileged to support a breakthrough that redefines treatment outcomes for millions suffering from dry AMD.”

Eyestem will be presenting its data at the ARVO 2025 Annual Meeting as well as the 10^th Retinal Cell and Gene Therapy Innovation Summit in early May.

For more information, please visit: https://clinicaltrials.gov/study/NCT06394232

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