Eyestem completes first round of patient injections for its dry AMD treatment
According to the company, the pre-clinical safety and efficacy studies of its product have yielded positive results in 3 internationally recognized labs in India, Singapore and the United States.
(Image credit: AdobeStock/Christian)
Eyestem Research Private Ltd hopes to shift the paradigm of ophthalmology in India with the completion of the first set of 3 patient injections for its RPE suspension therapy for dry age-related macular degeneration (AMD).
According to the company, AMD is a leading cause of blindness in individuals more than 60 years of age, impacting an estimated 196 million people globally.
The company’s Eyecyte-RPE is a patented suspension of retinal pigment epithelium cells aimed at combating geographic atrophy arising from dry AMD. This treatment, according to the company, has the potential to replace damaged retinal cells and treat this disease.
The first human trial, led by Rajani Battu, PhD, chief medical officer of Eyestem, will include 36 patients across 3 ophthalmology centers in India.
The first phase will treat 9 patients with very low vision and will concentrate on safety while the second phase will treat 27 patients with intermediate vision loss in order to determine efficacy
“Completing the first 3 patient injections of Eyecyte-RPE represents a critical milestone for our quest to find a cure for Dry AMD,” Battu said in the news release. “With the support of exceptionally skilled surgeons at our trial sites, we are optimistic that we can bridge the gap between lab application and real-world hope.
Rajpal Vohra, MD, of AIIMS, Delhi; Raja Narayanan, MD, of LV Prasad Eye Institute, Hyderabad; Rushikesh Naigonkar, MD, of Ganpati Netralaya, Jalna; and Rohan Chawla, also of AIIMS, Delhi, are all retinal surgeons involved in the study.
“Dry AMD and associated vision loss present a massive burden on patients in India and abroad” they said in a joint statement included in the news release. “We are excited about supporting this research which has the potential of helping such patients. It is a matter of great pride that such an innovation is coming out of India for the world and hope that this is the start of a new age of medicine where India leads the way.”
Ramesh Byrapaneni, MD, who is the managing director of Endiya Partners, expressed his support for the research.
“As a clinician and an early investor in Eyestem, I am thrilled to see Eyestem taking their first product developed from induced pluripotent stem cells into clinical development,” Byrapaneni said.
Since 2017, Eyestem has developed a scalable cell therapy platform for incurable diseases and is moving its flagship product for dry AMD into human trials.
According to the company, the pre-clinical safety and efficacy studies of its product have yielded positive results in 3 internationally recognized labs in India, Singapore, and the United States. The therapy showed beneficial effects on the degenerating retina in animal models without any major safety concerns, indicating its potential substantial therapeutic value for dry AMD.
