Eyestem Research Submits Investigational New Drug Application for Eyecyte-RPE™ to Begin Human Trials for Dry AMD Treatment
Bengaluru, Karnataka, June 5, 2023 — Dry age-related macular degeneration (dry AMD) remains the leading cause of irreversible blindness in individuals over the age of 50, affecting approximately 170 million people worldwide, with 25 million of those in India. As populations continue to age, the prevalence of this debilitating condition is expected to rise, with the more severe form, geographic atrophy, offering no available therapies to stop or reverse the vision loss associated with it.
In a significant breakthrough, Eyestem Research announced the submission of an Investigational New Drug (IND) application to the Central Drugs Standards Control Organization (CDSCO), India, to initiate first-in-human trials for its revolutionary treatment, Eyecyte-RPE™. This trial aims to evaluate the therapy for patients with medium- and late-stage geographic atrophy secondary to dry AMD.
Potential to Transform AMD Treatment
Dr. Rajani Battu, Chief Medical Officer at Eyestem Research, expressed her excitement about the human trials for Eyecyte-RPE™, stating, “We are thrilled to begin human trials for Eyecyte-RPE™. Dry AMD poses a substantial burden on patients worldwide, and this therapy has the potential to significantly improve the lives of those affected.”
Affordable Cell and Gene Therapy
Dr. Jogin Desai, Chief Executive Officer of Eyestem Research, emphasized the need for affordable access to cutting-edge treatments. He remarked, “Most cell and gene therapy products currently under development in Western markets are priced over US$200,000. Our vision is to democratize access to such therapies, making them available at a fraction of the cost and disrupting the current status quo with Eyecyte-RPE™.”
Scientific Innovation Backed by Robust Data
Eyestem Research, an innovative company incubated at the Centre for Cellular and Molecular Platforms (Bangalore), is supported by DBT-BIRAC as well as prestigious Indian and global healthcare investors. The IND submission for Eyecyte-RPE™ is backed by strong Good Laboratory Practice (GLP) toxicology data from the Dabur Research Foundation in India and positive efficacy and safety data from animal models conducted at Oregon Health and Science University. Additionally, the company’s validation of the injection technique and dose-finding studies were completed in advanced animal models at the Singapore Eye Research Institute.
About Eyecyte-RPE™
Eyecyte-RPE™ is a patented suspension of induced pluripotent stem cell (iPSC)-derived retinal pigment epithelium (RPE) cells. These cells have shown high potency, safety, and efficacy in both in-vitro and in-vivo studies. The allogeneic nature of the cells means they can be stored for extended periods, providing a long-term solution for treating retinal conditions such as AMD.
With this IND application, Eyestem Research is poised to make significant strides in revolutionizing the treatment of dry AMD and improving the quality of life for millions of patients worldwide.
For more information on Eyestem Research and Eyecyte-RPE™, visit Eyestem Research.
Rajneesh Singh is a journalist at Asian News, specializing in entertainment, culture, international affairs, and financial technology. With a keen eye for the latest trends and developments, he delivers fresh, insightful perspectives to his audience. Rajneesh’s passion for storytelling and thorough reporting has established him as a trusted voice in the industry.
