The Drugs Controller General of India (DCGI) has given final approval to ENTOD Pharmaceuticals PresVu eye drops, which were designed primarily to lessen reliance on reading glasses for people suffering from presbyopia, a common age-related visual disorder that mainly affects people over 40. The approval comes after an earlier proposal from the Central Drugs Standard Control Organisation's Subject Expert Committee (SEC).

"PresVu has also been applied for a patent for this invention in terms of its formulation and the process. The proprietary formula not only gets rid of reading glasses but also helps the patient lubricate their eyes as a side benefit. These eye drops utilise advanced dynamic buffer technology to swiftly adapt to tear pH, ensuring consistent efficacy and safety for extended use, keeping in mind that such drops will be used for years at a stretch," according to a press release published by the pharmaceutical company.

DCGI
Image Source: Medical Dialogues

What is Presbyopia?

Presbyopia is a normal result of ageing in which the eye's ability to focus weakens, causing difficulties focussing on close objects. This medical condition can have a substantial influence on a person's quality of life, limiting their ability to do everyday duties and maintain their current lifestyle. Many people discover presbyopia when they begin holding reading materials at arm's length in order to view them clearly. A routine eye exam can help confirm the diagnosis.

Nikkhil K. Masurkar, CEO of ENTOD Pharmaceuticals, stated, "DCGI approval is a significant step forward in our mission to transform eye care in India." PresVu has the potential to improve millions of people's lives by providing them with increased visual freedom.

According to industry projections, presbyopia affects between 1.09 to 1.8 billion people worldwide.
When asked about the company's future goals, Masurkar stated that the primary focus will be on meeting demand in both domestic and emerging regions such as Africa and South East Asia.
He stated that the corporation intends to innovate items in India and then license them in the United States market. Entod does not yet 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 explained. He stated that the company's objective is to offer pharmaceuticals to countries where they do not have access or where affordability is an issue.

"Like Africa is a classic example of that, where we are also focussing quite aggressively on Africa and introducing new molecules which have never been introduced by the so-called big pharma," he went on to say. Furthermore, India is a massive market that has yet to be properly explored, he stated. "Beyond India, we as a company are looking at more countries of the global south where we can create an impact," he said.

Masurkar stated that the company, with its production infrastructure in Maharashtra, focusses on three therapeutic areas: ENT, ophthalmology, and dermatology. He noted that the corporation may eventually enter the mental health industry. "If we were to enter a different segment, it would probably be something to do with mental health, which I think has huge scope in India," Masurkar told reporters.

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