Entod Pharmaceuticals gets DCGI nod for eye drops to treat presbyopia

New Delhi: Entod Pharmaceuticals on Tuesday said it has received approval from the Drug Controller General of India (DCGI) to market eye drops for the treatment of presbyopia.

The Mumbai-based drugmaker has received a final approval for PresVu eye drops and plans to introduce it in the domestic market in the first week of October.

The approval follows an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40.

"This DCGI approval is a major step forward in our mission to transform eye care in India. PresVu is more than just a product; it's a solution that stands to improve the lives of millions by offering them greater visual independence," Entod Pharmaceuticals CEO Nikkhil K Masurkar said.

According to industry estimates, 1.09-1.8 billion individuals globally are estimated to be affected by presbyopia.

The condition occurs as a natural consequence of ageing when the eye's ability to focus diminishes, leading to difficulty in focussing on close objects.

Asked about the company's future plans, Masurkar said the focus will be to cater to demand in domestic and emerging markets like Africa and South East Asia.

He noted that the company aims to innovate products in India and then out licence them in the US market.

Entod currently does not have a presence in the US market.

"The majority of the exports to the US are basically low cost generics. We want to change that scene, because we don't get excited by that. What we get excited about is to do something completely innovative and be the global innovator, and then out licence to these countries. So yes, that is our future plan," Masurkar stated.

The company's agenda is to supply medicines to countries where they don't have access, where affordability is a challenge, he added.

"Like Africa is a classic example of that, where we are also focusing quite aggressively on Africa and introducing new molecules which have never been introduced by the so-called big pharma," he said.

Besides, India is a huge market and is yet to be tapped fully, he said.

"Beyond India, we as a company are looking at more countries of the global south where we can create an impact," he added.

Masurkar said the company, which has its manufacturing infrastructure based in Maharashtra, is focussed on three therapeutic areas -- ENT, ophthalmology and dermatology.

In future, the company may look getting into the the mental health segment, he added.

"If we were to enter a different segment, it would probably be something to do with the mental health, which I think has huge scope in India," Masurkar said.