Entod Pharmaceuticals Receives Approval for Revolutionary Presbyopia Eye Drops

Entod Pharmaceuticals, a Mumbai-based company, has announced that its innovative eye drops, PresVu, have received final approval from the Drug Controller General of India (DCGI) on September 3, 2024. This approval represents a significant advancement in the treatment of presbyopia, a common age-related vision issue.

The Chief Executive Officer (CEO) of Entod Pharmaceuticals, Nikkhil K Masurkar, described PresVu as a ‘revolutionary treatment for presbyopia.’ The eye drops are specifically designed to reduce reliance on reading glasses for individuals aged 40 to 55 who have mild to intermediate presbyopia. Masurkar emphasized that PresVu provides a viable alternative to traditional reading glasses.

The approval by the DCGI comes after a favorable recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). Following successful multi-centric Phase 3 clinical trials conducted in India, the product is set to be launched in the domestic market in the first week of October.

Presbyopia is defined as the gradual loss of the eye’s ability to focus on nearby objects, a condition which generally becomes apparent in individuals in their early to mid-40s and continues to worsen until around age 65. Mayo Clinic explains that this natural part of aging affects a considerable portion of the population worldwide.

According to Masurkar, the therapy has undergone thorough testing for both efficacy and safety, and it has received approval from the U.S. Food and Drug Administration (FDA) as well. The company aims to innovate in the Indian market and subsequently introduce its products to international markets, focusing on regions such as Africa and Southeast Asia.

Each vial of PresVu will be priced at ₹345 and is designed to last for approximately one month. Users must apply one drop of the medication in each eye daily, with effects lasting around six hours. The drug purportedly begins to work within 15 minutes of application, while full benefits are expected after about 15 days of consistent use.