Come October And You Can Get Rid Of Your Reading Glasses; Know How

New Delhi: Entod Pharmaceuticals on Tuesday said it has received approval from the Drug Controller General of India (DCGI) to market India’s first eye drops to remove the need for reading glasses.

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

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 was quoted as saying by Republic World.

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.

“Till now, there was no medicine-based solution for blurry, near-vision except wearing reading glasses, contact lenses or a few surgical interventions,” he added.

Entod Pharmaceuticals specialises in ophthalmic, ENT and dermatology medicines and exports to more than 60 countries.

The medicine will be available across pharmacies only on prescription by registered medical practitioners from the first week of October and will cost Rs 350. The company has started training its field force to inform and educate doctors about the usage of the latest product

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 was quoted as saying.

Masurkar explained that the company had applied for DCGI approval in early 2022 and 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 told News18.

82 per cent of the total 274 subjects did not face any side effects. The 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 a couple of days. Once the 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.