Eyestem to Start Human Trials for Its Pioneering Dry AMD Treatment

03rd April 2024: Eyestem, a cell therapy company at the forefront of regenerative therapy, has received approval from India’s Central Drugs Standards Control Organisation (CDSCO) to commence human trials for Eyecyte RPE™, aimed at combating geographic atrophy arising from dry age-related macular degeneration (AMD).

“The commencement of human trials represents a significant and proud moment for all of us at Eyestem,” stated Dr. Jogin Desai, Founder and Chief Executive Officer, Eyestem  “Being a purpose-driven company, our commitment is to ensure that Eyecyte RPE™ reaches a much larger patient base than most cell and gene therapies worldwide. Our cell therapy platform has the ability to create products of the highest quality at scale, and we look forward to validating this hypothesis with our flagship product,” added Dr. Desai.

“We are delighted to be part of this pioneering effort in this area from our country. The LVP team is solidly behind this project and are optimistic about its success,” commented Dr. Gullapalli N Rao, Chairman, Founder, L. V. Prasad Eye Institute, Hyderabad.

Dry AMD, a leading cause of vision loss in the ageing population of people over 50, has long been a challenge due to the limited availability of effective treatments and the high costs associated with emerging therapeutic options. However, Eyestem’s Eyecyte RPE™ therapy, which aims to replace lost or damaged retinal pigment epithelium (RPE) cells, represents a transformational shift in aiming to tackle the disease. It aims to preserve and potentially improve sight for patients in the early stages of dry AMD and arrest vision loss for those in the later stages.

“I am absolutely delighted at Eyestem receiving approval to conduct clinical trials in India for Eyecyte RPE™. The management team’s deep commitment to their purpose and their thoughtful execution have enabled them to produce a product of the highest quality, which has the potential to create great impact for India and the world,” said Nitin Deshmukh, Advisor  Private Equity, Kotak Alternative Investments. 

“We are proud of being associated with Eyestem as one of its earliest backers and look forward to them disrupting this sector. The next wave in biotech will be driven by frugal innovation, and companies like Eyestem will lead the way,” added Gert Hoogland representing Jacesa Investments.  

“It is not every day that one can be associated with a true innovation that goes from bench to bedside. Today is a momentous day for us as we take the first iPSC-derived cell therapy solution from India onwards into the clinic,” added Dr. Rajarshi Pal, Chief Scientist, Eyestem

“There is no treatment for GA secondary to dry AMD anywhere in the world that can offer the potential of improvement in vision. I am hopeful that we will be able to demonstrate safety/efficacy for our product and eventually bring succour to millions of patients in India and abroad,” remarked Dr. Rajani Battu, Chief Medical Officer, Eyestem.

India has 40 million patients who suffer from dry age-related macular degeneration (dry AMD). Worldwide, the number of dry AMD patients is about 170M. The more severe version of this disease is geographic atrophy, which is one of the largest causes of legal blindness for people over 50 years of age. As of now, no therapy is available that can aim to arrest and reverse the loss of vision associated with the same.