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Eyestem files for IND approval for its product to treat geographic atrophy, the largest cause of incurable blindness



2024-06-13 05:03:05 Health and Fitness

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Bengaluru, June 5, 2023: 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.

Eyestem Research today 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 patients' lives."

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 US$ 200,000.Our vision is to democratize 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, Bangalore, 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.

About Eyecyte-RPE?

Eyecyte-RPE? is a patented suspension of iPSC-derived fate-committed retinal pigment epithelium cells, which are highly potent, safe, and efficacious in in-vitro and in-vivo studies. The cells are derived from induced pluripotent stem cells, are allogeneic in nature, and can be stored for long periods of time.

About Eyestem Research

Headquartered in Bangalore and Delaware, Eyestem Research is a clinical-stage biotechnology company, which was started by a founding team with several decades of experience in pharmaceutical product development, ophthalmology, and cell biology. It has won significant accolades with the most recent one being named the top innovator in the country across all sectors in 2022 by the prestigious The Economic Times newspaper. It is also the recipient of several prestigious grants from the Department of Biotechnology, Government of India, and has been feted at high-profile government functions as one of the most successful startups in the country. In addition to being backed by global investors in Switzerland and South Africa, it is backed by two of the most prestigious venture capital firms in the country ? Kotak Investment Advisors and Endiya Partners. Its most recent fundraise was backed by a consortium of three multi-billion dollar Indian pharmaceutical companies ?Alkem Laboratories, NATCO, and Biological E.

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