Starting in the first week of October, a revolutionary new eye drop that could eliminate the need for reading glasses will be available across pharmacies in India. Priced at ₹350, these prescription-based drops, named “PresVu,” are specifically designed to treat mild to intermediate presbyopia in individuals aged 40 to 55 years. The drug, which has been under development and scrutiny for over two years, marks India’s first approved eye drops aimed at reducing reliance on reading glasses.
A Breakthrough in Presbyopia Treatment
On Tuesday, Entod Pharmaceuticals, a Mumbai-based company, announced the launch of “PresVu” eye drops. The drops utilize pilocarpine, a medication that addresses presbyopia by reducing the size of the pupils, thereby enhancing the ability to see objects up close. Presbyopia, a condition associated with aging, is characterized by the gradual loss of the eyes’ ability to focus on nearby objects, typically becoming noticeable in the mid-40s and progressively worsening until around the late 60s.
In an interview with News18, Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, explained that a single drop of “PresVu” begins to work within just 15 minutes, with effects lasting up to six hours. For prolonged effectiveness, a second drop can be administered three to six hours after the first, extending the duration of its benefits.
“Until now, the only solutions for blurry near vision were reading glasses, contact lenses, or surgical interventions,” said Masurkar. Entod Pharmaceuticals, known for its specialization in ophthalmic, ENT, and dermatology medicines, exports its products to over 60 countries.
Who Can Use “PresVu”?
Beginning in October, “PresVu” eye drops will be available at pharmacies, but only with a prescription from a registered medical practitioner. The medicine is specifically indicated for individuals between the ages of 40 and 55 who suffer from mild to intermediate presbyopia.
Masurkar emphasized that “PresVu” is the first of its kind in India, tailored specifically for Indian eyes and adapted to the genetic makeup of the Indian population. “Similar medications are available in other countries, but those formulations have not been tested on Indian eyes, which differ significantly from Caucasian eyes. We have made several modifications to the formulation,” Masurkar noted.
To ensure that healthcare professionals are well-informed about this new product, Entod Pharmaceuticals has begun training its field force to educate doctors on the usage and benefits of “PresVu.”
Clinical Trials and Regulatory Approval
Masurkar revealed that the company applied for approval from the Drug Controller General of India (DCGI) in early 2022 and was required to conduct phase III clinical trials. These trials were conducted at ten sites across India, involving over 250 patients. The results, which were submitted to the regulatory agency, led to the approval of “PresVu” by the subject expert committee.
The clinical trials showed that 82% of the 274 subjects experienced no side effects. The remaining participants reported minor, transient side effects such as eye irritation, redness, blurred vision, and headaches, all of which resolved within a few days. “These side effects were temporary, and once the patients adapted, there were no further issues. No patients were discontinued from the trial,” Masurkar stated.
Although the results of the study have yet to be published in a peer-reviewed journal, Entod Pharmaceuticals is planning post-marketing surveillance at major eye-care centers across India, including the All India Institute of Medical Sciences (AIIMS) in New Delhi. “We will publish the results in medical journals, but our current focus is on preparing for post-marketing surveillance, which will help us better understand the various aspects of the medicine,” added Masurkar.
With the launch of “PresVu,” India is set to enter a new era of eye care, offering millions of people a convenient and non-invasive solution to presbyopia, potentially reducing the need for reading glasses.