Eyestem files for CDSCO approval for Eyecyte-RPE

Eyecyte-RPE will be used to treat geographic atrophy

Eyestem Research 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 AMD.


Dr Rajani Battu, Chief Medical Officer, Eyestem Research, said, “We are excited to start human trials for Eyecyte-RPE. Dry AMD is a huge disease burden, and this therapy has the potential to make a meaningful difference in our patient’s lives.”

Dr Jogin Desai, CEO, 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, Bengaluru, and supported by DBT-BIRAC as well as 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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