Coming Soon: Eye drops that can help you put away your reading glasses

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Within months of the United States Food and Drug Administration approving eye drops that can eliminate the need for reading glasses in middle-aged people, an Indian company is also looking to launch a similar solution in the country.

The drug approved by the USFDA has to be applied to each eye once a day and starts working within 15 minutes of application. The effect of each application lasts for at least six hours. The drug is a formulation of a well-known compound known as pilocarpine.

In India, Mumbai based Entod Pharmaceuticals is now in the final stages of launching the eye drops, using the same active agent permitted in the US. The drops will help people with near-vision loss or presbyopia replace their reading glasses.

The company says the drops, developed by its Department of Scientific and Industrial Research-approved laboratory, will be available under the brand name PresVu. They will be the first such eye drops to treat presbyopia.

Promising results

According to CEO Nikkhil K Masurkar, clinical studies have shown that these eye drops work best in people aged 40 to 55 years, in mild to intermediate cases of presbyopia, thereby temporarily correcting vision problems.

The company is going to apply for final marketing approval from the Central Drug Standards Control Organisation next month, Masurkar told Moneycontrol.

The CEO added that the firm intends to sell eye drops at an affordable price in India, making them less expensive than reading glasses.

Presbyopia in India

Near-vision loss or presbyopia means inability to focus on nearby objects and usually sets in from the mid-40s.

In a new data analysis, which took six to seven years to compile, the Vision Loss Expert Group (VLEG) and the International Agency for the Prevention of Blindness (IAPB) found that there were 507 million cases of near-vision loss in the world, with 137.6 million of them in India.

The prevalence of uncorrected presbyopia was 33 percent, it was found.

Indian addition to active agent

The active agent used in this eye drop has already been tested and approved in the US for treatment of presbyopia.

However, the “innovative” formulation developed by ENTOD has the ability to rapidly adjust to the pH of the tears in the eyes through a unique dynamic buffer technology that makes them ideal for long-term use and safety, the company claims.

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Eye drops containing the same active agent have already undergone phase 3 clinical trials in the US, showing impressive results and winning approval there, said Masurkar.

In India, the company has currently completed the formulation development of these eye drops. It will be applying to the Drug Controller General of India for approval, citing clinical trials in the US and its own studies locally.