Eyestem receives CDSCO approval to initiate Phase 2 randomised, controlled human trials of Eyecyte-RPE

Eyestem Research Pvt Ltd, a biotechnology company, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to initiate the clinical trial of its investigational retinal pigment epithelium (RPE) cell therapy, Eyecyte-RPE™ in India. The randomised, controlled phase 2 clinical trials will evaluate the safety and efficacy of Eyecyte-RPE™ in a larger group of subjects with moderate geographic atrophy (GA) and associated vision loss.

The approval follows the successful completion of Eyestem’s Phase 1 clinical study of Eyecyte-RPE™, being developed for patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD).

Jogin Desai, Founder and CEO, Eyestem, said in a statement, “There is no available therapy that reverses blindness caused by geographic atrophy (GA), affecting an estimated 8 million patients worldwide. Eyestem is among a few companies globally pursuing a scalable cell therapy approach toward a potential cure. CDSCO approval enables us to advance Eyecyte-RPE™ into Phase 2 clinical evaluation, allowing broader, randomised validation of our best-in-class Phase 1 outcomes. With AMD projected to affect 288 million people by 2040, this marks a major milestone in our mission to transform retinal care and patient lives worldwide.”


The advancement to Phase 2 of Eyestem’s lead therapy is supported by capital raised in a recent funding round. Eyestem is also preparing to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA), enabling the planned initiation of clinical studies in the United States.