PresVue eye drops, developed at Entod Pharmaceuticals' R&D centre in India, received final approval from the Drug Controller General of India (DCGI) on Tuesday, September 3, marking a significant advancement in the treatment of presbyopia, reports said.

The Mumbai-based company's Chief Executive Officer (CEO), Nikkhil K Masurkar, described PresVue as a “revolutionary treatment for presbyopia.

”PresVue emerges as the first alternative to reading glasses among individuals aged 40 to 55 with mild to intermediate presbyopia, providing a viable alternative to traditional interventions like reading glasses, Masurkar said in a post on LinkedIn four months ago.

Masurkar said in his LinkedIn post in May that PresVue was previously approved by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

“The approval comes following successful multi-centric phase 3 trials carried out in India by ENTOD,” he had posted.

Entod Pharmaceuticals developed PresVue to reduce dependency on reading glasses for individuals with presbyopia.

They are the first to introduce eye drops of this kind in India.

Presbyopia is the gradual loss of the eye's ability to focus on nearby objects, explained Mayo Clinic.

It's a natural part of ageing that usually becomes noticeable in the early to mid-40s and worsens until about age 65.

“This therapy is not just thoroughly tested for efficacy and safety in Indian eyes but is also USFDA approved,” CEO Masurkar had said.

According to news agencies, the Mumbai-based drugmaker plans to introduce PresVue eye drops in the domestic market in the first week of October.

Masurkar was quoted as saying that the company will focus on meeting demand in domestic and emerging markets, including Africa and Southeast Asia.

He said the company aims to innovate products in India and then out-license them in the US market.

In a statement on Tuesday, the company said a single vial of PresVue eye drops will retail for ₹345.

The vial is designed to last about a month.

People must typically use the medication once daily, and its effects can last several hours.

People must use the eye drops only with a prescription from an ophthalmologist.

Only 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 has reportedly claimed the drug starts working within 15 minutes of application, but complete benefits are likely to be visible after 15 days of use.