An eye drop that can potentially replace reading glasses for middle-aged people was launched in India recently, following marketing authorisation approval by the Drugs Controller General of India (DCGI) last month. This will be India’s first such eye drop.
The drug contains 1.25% pilocarpine hydrochloride and has been developed and launched by Mumbai-based pharmaceutical firm Entod Pharmaceuticals under the brand name PresVu. Pilocarpine, a plant-derived compound, has been used for decades to treat various eye conditions and dry mouth, and reduce eye pressure, among other applications.
It is meant to address presbyopia, a common age-related vision condition that typically impacts those over 40, causing the eyes to gradually lose their ability to focus on nearby objects. A single vial of the eye drop, which is designed to last about a month, will cost Rs 345.
Data from phase 3 clinical trials of the drug—carried out in 250 patients across 10 sites—submitted to the DCGI showed that it works best in people aged 40 to 55 years with mild-to-intermediate presbyopia, temporarily correcting vision problems.
A similar formulation was launched in the US in 2022 under the brand name Vuity, following regulatory approval by the US Food and Drug Administration (US FDA). Vuity is the only FDA-approved eye drop that can treat age-related blurry vision.
Nikhil Masurkar, CEO of Entod Pharmaceuticals, said that the eye drop’s launch in India is a result of extensive research that started in 2019. It is estimated, he added, that nearly 45% of Indians above the age of 40 years have presbyopia. The drug is expected to be available in pharmacies across India by October, the CEO said.
The eye drop must be used only under prescription by an ophthalmologist. One drop of the drug should be put in each eye every day. The effect lasts about six hours. An additional drop can be put in each eye three to six hours after the first drop. This can potentially correct blurred vision for three more hours.
Entod Pharmaceuticals claims that the drug starts working within 15 minutes of application but complete benefits are likely to be visible after 15 days of use.
Dr Dhananjay Bakhle, a senior pharmacologist and advisor to Entod Pharmaceuticals, said that for patients with presbyopia, the eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses. “Its rapid efficacy and safety profile, demonstrated in clinical trials, makes it a valuable addition to the treatment arsenal,” Bakhle said.
