Starting first week of October, prescription-based drops will be available across pharmacies costing Rs 350. The medicine is indicated for the treatment of mild to intermediate presbyopia for people aged 40 to 55 years.
After deliberating over the medicine for over two years, the drug regulatory agency has approved India’s first eye drops to remove the need for reading glasses.
On Tuesday, Mumbai-headquartered Entod Pharmaceuticals launched “PresVu” eye drops made using pilocarpine – the medicine that treats ‘presbyopia’ by reducing the size of the pupils which helps to see objects up close. Presbyopia condition is the age-linked decline in the eyes’ ability to focus on nearby objects and this condition typically becomes noticeable mid-40s and worsens until about age of late 60s.
In an interview with News18, Nikkhil K Masurkar, chief executive officer (CEO) of Entod Pharmaceuticals 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.
“Till now, there was no medicine-based solution for blurry, near-vision except wearing reading glasses, contact lenses or a few surgical interventions.”
Entod Pharmaceuticals specialises in ophthalmic, ENT and dermatology medicines and exports to more than 60 countries.
Who can buy this medicine?
Starting from the first week of October, prescription-based drops will be available across pharmacies costing Rs 350. The medicine is indicated for the treatment of mild to intermediate presbyopia for people aged 40 to 55 years.
Masurkar claims that the medicine is the first of its kind in India which 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 said.
The product will be sold only on prescriptions by registered medical practitioners. The company has started training its field force to inform and educate doctors about the usage of the latest product.
Phase III successful, gearing up for post-launch surveillance
Masurkar explained that the company had applied for the DCGI approval in early 2022 and the company was asked to conduct phase III clinical trials.
“We conducted the trials at ten sites across India with more than 250 patients. The results and data were submitted to the regulatory agency. The subject expert committee approved the study and recommended for approval from the drug controller general,” he said.
82 per cent of the total 274 subjects did not face any side effects. Remaining patients reported minor transient side effects including irritation and redness in eyes, blurring of vision and headache. “These all were transient side effects and resolved in couple of days. Once patient adapts, there should not be issues. No patient was discontinued from the trial,” he said.
While the results of the study are yet to be published in a peer-reviewed journal, the company plans to conduct post-marketing surveillance at several big eye-care centres across India including All India Institute of Medical Sciences (AIIMS), New Delhi.
“We will get the results published in medical journals as well but right now, we are preparing for post-marketing surveillance which can help us understand the different aspects of the medicine,” Masurkar added.
