The Drug Controller General of India (DCGI), India’s drug regulatory body, has authorised the country’s first eye drops that eliminate the need for reading glasses.
The development comes after more than two years of consideration of the medication.
On Tuesday, Entod Pharmaceuticals launched the “PresVu” eye drop that treats presbyopia.
Here’s all we know about it.
What is PresVu?
PresVu is the first eye drop in India that has been created specifically to minimise dependency on reading glasses for people affected by presbyopia.
The eye drop was approved by the DCGI following an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), as per PTI.
The manufacturers have submitted an application for patent protection for both the specialised formulation and the production method.
The distinctive formulation has a further advantage of moisturising the eyes in addition to removing the need for reading glasses.
Because of its sophisticated dynamic buffer technology, the eye drops can instantly adjust to the pH of tears, guaranteeing long-term safety and consistent efficacy, according to India Today.
“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’ Chief Executive Officer Nikkhil K Masurkar said, according to Wion News.
Entod Pharmaceuticals specialises in ophthalmic, ENT and dermatology medicines and exports to more than 60 countries, as per News18.
“Till now, there was no medicine-based solution for blurry, near-vision except wearing reading glasses, contact lenses or a few surgical interventions,” he said in an interview with the news channel.
What is presbyopia?
According to Mayo Clinic, presbyopia is the gradual loss of one’s eyes’ ability to focus on nearby objects.
The condition usually becomes noticeable in the mid-40s and worsens until about the age of the late 60s.
The clinic says that the condition can be corrected with eyeglasses, contact lenses or even surgery.
Citing industry stands, PTI said that 1.09–1.8 billion people globally are estimated to be affected by the condition.
Masurkar, citing estimates, says that in India, nearly 45 per cent of people above 40 years have presbyopia.
How does the eye drop work?
PresVu is made using pilocarpine, a plant-derived compound that has been used for decades to treat various eye conditions and dry mouth, and reduce eye pressure, among other applications, according to The Print.
The medicine works by reducing the size of pupils which helps to see objects up close, as per News18.
In an interview with News18, Masurkar said a single drop of the medicine starts working in just 15 minutes and its effects remain for the next six hours.
If the second drop is also poured within three to six hours of the first drop, the effect will stay even longer.
Phase 3 clinical trials of the medicine, involving 250 patients at 10 sites, yielded data submitted to the DCGI that indicated the treatment’s best effectiveness in temporarily resolving vision issues in adults with mild-to-intermediate presbyopia aged 40 to 55.
The eye drop can only be used with an ophthalmologist’s prescription.
Is it suited for Indian eyes?
Masurkar claims that the medicine is the first of its kind in India that is tested on Indian eyes and customised as per the genetic fulcrum of the Indian population.
“Similar medicines are available in foreign countries. However, those formulations are not tested on Indian eyes, which are much different from caucasian eyes. We have made several changes in the formulation,” Masurkar told News18.
With US Food and Drug Administration (US FDA) regulatory approval, a formulation akin to this one was introduced in the US in 2022 under the brand name Vuity. It is the only FDA-approved eye drop for treating age-related blurred vision.
According to CEO Masurkar, PresVu has adjuvants — components other than the active ingredient in pharmaceuticals — that are distinct from those in Vuity.
This is because Indian irises are usually more pigmented, as per The Print.
When will it be available?
The company based in Mumbai intends to launch them in the Indian market during the first week of October.
The eye drop is intended to last almost a month, and a single vial will cost Rs 345.
The product will only be distributed with a prescription from a licensed medical professional.
The company has begun to train its field staff on how to use the newest product, to inform and educate doctors.
When asked about the company’s future goals, Masurkar stated that meeting demand in both home and growing countries, such as Southeast Asia and Africa, will be the main priority.
Additionally, he mentioned that the company’s goal was to invent items in India and subsequently outlicense them in the US.
With inputs from agencies
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Coming soon to India: New eye drops that could eliminate the need for reading glasses
