Eyestem receives positive recommendation from the Drug Safety Monitoring Board(DSMB) for the first set of patient injections for its pioneering Dry AMD treatment

Eyestem Research Private Limited, a company focused on creating scalable cell therapies for incurable diseases, is delighted to announce a positive outcome of the Drug Safety Monitoring Board (DSMB) review for the first cohort of its Phase one trial to treat Geographic Atrophy secondary to Dry Age-related Macular Degeneration. Eyestem’s lead product, Eyecyte-RPE™, is a patented suspension of retinal pigment epithelium cells aimed at combating geographic atrophy arising from Dry AMD. This pioneering treatment marks a major milestone in the global fight against vision loss, as it has the potential to replace damaged retinal cells. Led by Dr Rajani Battu, Chief Medical Officer, Eyestem, this first in human trial will involve thirty-six patients across three of the most reputable ophthalmology centres in India. “ We are thrilled to receive DSMB approval for the first cohort and expect to begin injections for the second cohort in the next few weeks. The excellent safety profile for the first three patients is due to the exceptionally skilled surgeons at our trial sites as well as the scientific team at Eyestem which made a great product.’, she said. In a joint statement, Dr. Rajpal Vohra (AIIMS, Delhi) , Dr. Raja Narayanan (LV Prasad Eye Institute, Hyderabad), Dr. Rushikesh Naigonkar (Sri Ganpati Netralaya, Jalna), and Dr. Rohan Chawla (AIIMS, Delhi), retinal surgeons involved in the study, said “ We are truly excited to see the excellent safety profile of Eyecyte-RPE and early indications of efficacy lead us to believe that this therapy has the potential to be transformational for patients. We look forward to recruiting the second cohort of patients and are excited to be part of the team that brings such innovative therapies closer to patients that need it most.” Since 2017, Bengaluru-based Eyestem has developed a scalable cell therapy platform for incurable diseases and is moving its flagship product for Dry AMD into human trials. The preclinical safety and efficacy studies of Eyecyte-RPE™ have yielded highly encouraging results in three internationally recognised labs in India, Singapore and the US. The therapy demonstrated significant beneficial effects on the degenerating retina in animal models without any major safety concerns, indicating its potential value for combating Dry AMD. In addition to its clinical significance, this trial marks a critical milestone for Indian science. This initiative showcases the country’s growing capabilities in advanced medical research and its potential to be a leader in the global Biotechnology industry. Additional information: Clinical Trial Registry of India (www.ctri.nic.in) : Trial number CTRI/2024/04/065639 ClinicalTrials.gov https://clinicaltrials.gov/study/NCT06394232?term=eyestem&rank=2 About Eyecyte-RPE™ Human induced pluripotent stem cells (hiPSCs) derived Eyecyte-RPE™, developed by Eyestem, can help replace the damaged or lost retinal pigment epithelial (RPE) cells and potentially enable tissue regeneration in the diseased retina. In addition, stem cells can perform multiple functions, such as immunoregulation, prevention of apoptosis in sensory neurons, and secretion of neurotrophic factors. 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 Bengaluru 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, retinal surgery, and cell biology. It has won significant accolades with the most recent one being named the top innovator in India 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, Eyestem Research 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.

The release as fetched from its publisher. eyestem.com ↗