A locally developed product for wet AMD (age-related macular degeneration) is hopeful of being commercialised in India in early 2025 through a local collaboration between Mumbai’s Vav Life Sciences and Madurai’s Aurolab Trust, the manufacturing division of Aravind Eye Hospital.

The product awaits a final regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) and will be less expensive and “more bio-available (better absorbed into the body)”, said Arun Kedia, Managing Director of Vav Life Sciences told businessline. The formulation uses VAV’s synthetic phospholipid for better delivery of the drug, he explained.

The product involves an intravenous liposomal Verteporfin injection, along with photodynamic therapy (light), to treat AMD. According to industry insiders, there are no locally made products to treat wet AMD. The existing product in this therapeutic segment is imported at about ₹70,000, a company official said.

The product is a first in the country, says Kedia, adding that “all development work including cell line studies, in-vivo evaluations and long term stability trials are completed.” It has been developed by the inhouse scientific team of Aurolab, with inputs from VAV’s nanotechnology scientists, he added.

VAV is a nanotechnology research-based company that makes lipids used in drug delivery and during Covid-19, it was among four global companies making phospholipids for mRNA Covid-19 vaccines.

While the CDSCO’s response is awaited, he said, the Aurolabs team is working on its manufacturing capacity, as the entire product would have to be produced at the site. The hospital’s approach has been to produce treatment free or at subsidised rates, and that philosophy would prevail with the latest product as well, said Kedia, adding that discussions on pricing, etc., would be revealed by them after the regulatory approval is received.

AMD is a global concern, with a largely ageing population particularly vulnerable to the condition. Another company, Eyestem, is presently undertaking trials in India for its potential product for dry AMD. In April, the CDSCO green-lighted clinical trials on the product aimed at addressing geographic atrophy arising from dry AMD, the company said.

(eom)

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