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Bengaluru-based health startup Eyestem announced on Wednesday that it has received approval from the Central Drugs Standards Control Organisation (CDSCO) to commence human trials for Eyecyte RPE, an injectable allogeneic for combating dry age-related macular degeneration (AMD).
Commenting on the development, Jogin Desai, founder and chief executive officer (CEO) of Eyestem, said that the company will be starting with their Phase 1/2a trials in two to three months. “We are aiming to recruit volunteers within the next six to eight weeks,” he said.
“We will be conducting safety trials on people who are in an advanced stage of vision loss and then monitor them,” he added.
Dry AMD causes degeneration of retinal cells resulting in vision loss in people over the age of 60. Over 170 million people suffer from dry AMD globally, of which 40 million patients are in India.
“The more severe version of this disease is geographic atrophy, which is one of the largest causes of legal blindness for people over 60 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 company said in a press release.
Eyecyte RPE therapy aims to become the first therapy in India capable of replacing lost or damaged retinal pigment epithelium (RPE) cells. “We are aiming 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,” said Rajani Battu, chief medical officer at Eyestem.
Commenting on the price of the therapy, Battu said that they are on the right track to keep the cost affordable for patients in India. “Since Eyecyte RPE is an allogeneic subretinal injection, there won't be any need to customize the therapy for different patients,” Battu said.
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Given the huge unmet need in India, there is a possibility that there would not be a need to conduct phase 3 trials for the therapy, Desai said. “The final decision will rest with the regulators,” he added.
Speaking on the startup’s future plans, Desai said that the company is developing treatments for retinitis pigmentosa and idiopathic pulmonary fibrosis. “We have developed the product for retinitis pigmentosa, which affects children from the age of five who start to lose vision (because of loss of photoreceptors), and they become completely blind by 30,” he said.
“The 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 through human trials,” he added.
