Cell therapy company Eyestem has received regulatory approval to start human trials for Eyecyte RPE, to tackle dry age-related macular degeneration (AMD).

The Central Drugs Standards Control Organisation has green-lighted clinical trials on the product aimed at addressing geographic atrophy arising from dry AMD, a note said.

Jogin Desai, Eyestem Founder and CEO had recently told businessline, that regulatory approvals on the potential therapy was expected in India, even as it prepared to take this investigational new drug to Australia.

The trial will be done at LV Prasad Eye Institute, Hyderabad; AIIMS – Delhi; and Ganapati Netralaya (Jalna, Maharashtra) and involved about 36 patients, he said.

Dry AMD is a leading cause of vision loss in people over 50 years and has been a challenge due to the limited availability of effective treatments and the high costs associated with emerging therapeutic options, Eyestem said. Eyestem’s potential therapy aims to replace lost or damaged retinal pigment epithelium (RPE) cells, it added.

India is estimated to have about 40 million patients who suffer from dry AMD. Worldwide, it’s about 170 million. “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,” the note said.

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