India-based Eyestem receives approval to commence human trial for Eyecyte RPE for AMD


Image credit: AdobeStock/rohane

(Image credit: AdobeStock/rohane)

Eyestem received approval from India’s Central Drugs Standards Control Organisation (CDSCO) to commence human trials for Eyecyte RPE, a potential treatment for geographic atrophy arising from dry age-related macular degeneration (AMD).

Dr Jogin Desai, Founder and Chief Executive Officer of Eyestem, gave his thoughts on this milestone in the company’s press release, saying, “The commencement of human trials of represents a significant and proud moment for all of us at Eyestem. Being a purpose-driven company, our commitment is to ensure that Eyecyte RPE reaches a much larger patient base than most cell and gene therapies worldwide. Our cell therapy platform has the ability to create products of the highest quality at scale, and we look forward to validating this hypothesis with our flagship product.”

Nitin Deshmukh, Kotak Alternative Investments, shared in the excitement of the human trials commencement, saying, “I am absolutely delighted at Eyestem receiving approval to conduct clinical trials in India for Eyecyte RPE. The management team’s deep commitment to their purpose and their thoughtful execution has enabled them to produce a product of the highest quality which has the potential to create great impact for India and the world.”

Gert Hoogland, Managing Partner, Jacesa Investments noted the company’s investment in Eyestem, saying, “ We are proud of being associated with Eyestem as one of its earliest backers and look forward to them disrupting this sector. The next wave in biotech will be driven by frugal innovation and companies like Eyestem will lead the way.”

Eyestem’s Eyecyte RPE therapy aims to replace lost or damaged Retinal Pigment Epithelium (RPE) cells, which is a shift in tackling the disease. The goal is to preserve and potentially improve sight for patients in the early stages of dry AMD and arrest vision loss for those in the later stages.

“It is not every day that one can be associated with a true innovation that goes form bench to bedside. Today is a momentous day for us as we take the first iPSC-derived cell therapy solution from India onwards into the clinic,” added Dr Rajarshi Pal, Chief Scientist, Eyestem.

1. Eyestem to Start Human Trials for its Pioneering Dry AMD Treatment. Eyestem. Published April 2, 2024. Access April 9, 2024.
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