After over two years of review, the Drug Regulatory Agency has approved India’s first eye drops for this purpose. On Tuesday, Mumbai-based Entod Pharmaceuticals launched “PresVu” eye drops, formulated with pilocarpine. This medication works by reducing the size of the pupils, improving near vision and helping individuals see objects up close. Presbyopia, typically noticeable in the mid-40s, progresses with age and usually becomes more pronounced by the late 60s.
Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, explained that a single drop of this medicine starts working within 15 minutes and remains effective for up to six hours. Applying a second drop within three to six hours after the first can extend the effect even further. “Until now, the only solutions for blurry near vision were reading glasses, contact lenses, or certain surgical procedures,” Masurkar noted.
Entod Pharmaceuticals, which specializes in ophthalmic, ENT, and dermatology medicines, exports its products to over 60 countries. Masurkar emphasized that this eye drop is the first of its kind in India, tailored specifically for Indian eyes. While similar products exist in other countries, those formulations were not tested on Indian eyes, which differ significantly from Caucasian eyes. The company made several adjustments to the formulation to suit the genetic profile of the Indian population.
The product will be available only with a prescription from registered medical practitioners. Entod Pharmaceuticals has begun training its field force to educate doctors on the proper use of this new product. 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 took place at ten sites across India, involving over 250 patients. According to Masurkar, the results showed that 82% of the 274 participants experienced no side effects, while the remaining patients reported minor, transient issues like eye irritation, redness, blurred vision, and headaches. All side effects were temporary and resolved within a few days, with no participants dropping out of the trial.
Although the study results are yet to be published in a peer-reviewed journal, Entod Pharmaceuticals plans to conduct post-marketing surveillance at several major eye-care centers across India, including the All India Institute of Medical Sciences (AIIMS) in New Delhi.