Eyestem Research seeks CDSCO approval to begin first in-human trials for its product to treat geographic atrophy
Eyestem Research has announced the submission of an Investigational New Drug (IND) application to the Central Drugs Standards Control Organization, India (CDSCO) to begin first in-human trials of Eyecyte-RPE for subjects with medium- and late-stage geographic atrophy, secondary to dry age-related macular degeneration (dry AMD).
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 Rajani Battu, chief medical officer, Eyestem Research, said,
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