Eyestem files for IND approval for product to treat geographic atrophy

05 June 2023 | News

Eyecyte-RPE is a patented suspension of Induced pluripotent stem cells (iPSC)-derived fate-committed retinal pigment epithelium cells

image credit- shutterstock

image credit- shutterstock

Bengaluru-based Eyestem Research has announced the submission of an Investigational New Drug (IND) application to the Central Drugs Standards Control Organisation (CDSCO) to begin first in-human trials of Eyecyte-RPE for subjects with medium- and late-stage geographic atrophy, secondary to dry AMD.

Dry age-related macular degeneration (dry AMD) is the largest cause of incurable blindness in the world for patients over 50 years. 170 million people suffer from this disease around the world, 25 million of which are in India. These numbers will unfortunately increase in the coming decades as our population ages. The more severe version of dry AMD is geographic atrophy,and no therapy is available to arrest or reverse this loss of vision.

Dr Jogin Desai, Chief Executive Officer, Eyestem Research, said, “Most cell and gene therapy products under development in the West are estimated to cost over $200,000. Our vision is to democratise access to such treatments at a fraction of these costs and begin disruption of the current status quo with our Eyecyte-RPE product.”

Eyestem Research is a deep science company incubated at the Centre for Cellular and Molecular Platforms, and supported by DBT-BIRAC as well as prestigious Indian and global healthcare investors. The IND submission for Eyecyte-RPE is supported by robust GLP toxicology data from Dabur Research Foundation in India and excellent efficacy/safety data in animal models at Oregon Health and Science University. Validation of the injection technique and dose-finding studies were done in advanced animal models at the Singapore Eye Research Institute.


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