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 in a statement, “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.
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.
