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Eyestem Research announces successful completion of pre-IND meeting with FDA

Eyestem Research, India’s premier cell therapy company, has announced the successful completion of pre-IND (Investigational New Drug) meeting with FDA regarding regulatory roadmaps for its flagship product.

The company aims to remedy hitherto incurable dry age-related macular degeneration (AMD) – the leading cause of blindness, affecting about 170 million people worldwide.

Eyecyte-RPE, a patent-pending suspension of retinal pigment epithelium cells, is designed to arrest and reverse symptoms of dry age-related macular degeneration (AMD) – an incurable cause of blindness that affects about 170 million people globally. Eyestem is among the very few companies worldwide which are racing to find a cure for this debilitating condition. Once the IND application is filed this year, the start-up plans to commence the clinical trials by next year.

Commenting on the positive development, Dr. Jogin Desai, founder and CEO, Eyestem said, “We are on a mission to democratise access to cell therapy and make it available to a large section of humanity. The pre-IND meeting is aimed at creating a validated regulatory roadmap and we are delighted to obtain encouraging feedback from the FDA on our intended development path. As the only Indian company in this segment, we are determined to make the most of our exceptional pre-clinical animal results in order to find a cure for Dry AMD. We are fortunate to have a superb partner in Ora clinical, the world’s leading ophthalmology research organisation for creation of the regulatory roadmap. We now look forward to starting clinical trials on the product by next year”

Last year, the company had raised an undisclosed amount in funding from global investors in Switzerland and South Africa. It is also ably supported through grants by BIRAC, the investment arm of the Department of Biotechnology, India and by Centre for Cellular and Molecular Platforms. The company will use this momentum to raise the next round of funds to get to the end of phase one trials.

According to Jeanne Hecht, CEO, Ora Clinical, as one of the top ophthalmic contract research organisations (CROs) in the world, we recognise the need to nurture ideas that can change the world. Eyestem’s pioneering work can halt the progression of dry AMD by using a unique composition of retinal cells to restore the health of the retina and we are incredibly excited to be partners in their journey”

Eyestem’s vision is to create a global and scalable cell therapy platform that produces consistent and quality products to treat incurable diseases. The company, founded by a top-class management team consisting of clinical trial, cell therapy and ophthalmology experts, boasts of a world-class advisory board and collaborations with pioneers and global industry leaders.

The eye’s macula, located near the center of the retina, is responsible for sharp, clear, straight-ahead vision. Dry Age-related macular degeneration (AMD) occurs when macula degenerates with increasing age. It starts with loss of central vision and ultimately leads to blindness. Wet AMD is a variant of AMD, is treatable and the global market of drugs for wet AMD is expected to reach US$ 8.9 billion by 2022. The incidence of dry AMD incidence is nine times that of wet AMD. Yet, there is no cure for dry AMD.