India, 14th April 2025: Eyestem Research, a Bangalore-based cell therapy company, is pleased to announce significant vision improvement in phase 1 trials of its investigational drug product, Eyecyte-RPE™, in patients 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 early treatment diabetic retinopathy study (ETDRS) standard vision tests within four to six months post-transplantation. Notably, retinal imaging scans revealed early signs of disease reversal in a handful of patients, indicating a remarkable advancement in cell therapy in ophthalmology.
The substantial vision improvement, sustained over a four–six 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 patients. We look forward to exploring these early results further in our phase two study in India and the US.
Dr Jogin Desai, Founder and CEO, Eyestem
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 Organisation (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.
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.
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)
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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.
Source: Eyestem
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