After over two years of deliberation, India’s drug regulatory agency has approved the country’s first eye drops designed to eliminate the need for reading glasses. The newly launched “PresVu” eye drops, developed by Mumbai-based Entod Pharmaceuticals, are made using pilocarpine, a medicine that treats presbyopia by reducing the size of the pupils, thereby enhancing the ability to see objects up close.
Presbyopia is an age-related condition that results in the eyes’ reduced ability to focus on nearby objects, typically becoming noticeable in the mid-40s and worsening until the late 60s. PresVu targets this condition, offering a non-surgical, medicine-based solution for blurry near-vision—a first for India.
In an interview with News18, Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, explained that a single drop of PresVu begins to take effect in just 15 minutes, with the effects lasting for up to six hours. “If a second drop is applied within three to six hours of the first, the effect can be prolonged even further,” Masurkar noted.
Prior to the introduction of PresVu, options for treating presbyopia were limited to reading glasses, contact lenses, or surgical interventions. Entod Pharmaceuticals, which specializes in ophthalmic, ENT, and dermatology medicines and exports to over 60 countries, has now expanded its portfolio with this innovative product.
According to Masurkar, PresVu is the first medication of its kind in India, specifically tested on Indian eyes and tailored to the genetic makeup of the Indian population. “Similar medicines are available in foreign countries, but their formulations have not been tested on Indian eyes, which differ significantly from Caucasian eyes. We have made several adjustments to the formulation to better suit Indian eyes,” he said.
The eye drops will be available across pharmacies starting in the first week of October, priced at Rs 350 per bottle. They are indicated for the treatment of mild to intermediate presbyopia in individuals aged 40 to 55 years and will be sold strictly on prescription by registered medical practitioners.
Entod Pharmaceuticals first applied for approval from the Drug Controller General of India (DCGI) in early 2022. The company was required to conduct phase III clinical trials, which were carried out at ten sites across India with more than 250 participants. “The results and data were submitted to the regulatory agency, and the subject expert committee recommended approval from the drug controller general,” Masurkar said.
While the study results have yet to be published in a peer-reviewed journal, the company plans to conduct post-marketing surveillance at major eye-care centers across India, including the All India Institute of Medical Sciences (AIIMS) in New Delhi. “We are preparing for post-marketing surveillance to understand the different aspects of the medicine better,” Masurkar added.
As Entod Pharmaceuticals gears up for the nationwide launch of PresVu, the company has started training its field force to educate doctors about the new product and its proper usage. The introduction of these eye drops marks a significant step forward in eye care for millions of Indians suffering from presbyopia, potentially reducing dependence on traditional corrective measures like glasses and contact lenses.
