Mumbai-based drug maker Entod Pharmaceuticals has launched a first-of-its-kind eye drop which helps middle aged people with sight issues like presbyopia, a common age-related vision condition. This condition typically impacts those over 40, causing the eyes to gradually lose their ability to focus on nearby objects.
The new drug can potentially replace reading glasses for middle-aged suffering from presbyopia.
The company had received the marketing approval from the Drug Controller General of India (DCGI) for the drug, known in generic term as pilocarpine hydrochloride, in August.
Branded as PresVu in India, the drug contains 1.25 percent 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.
The company said in Tuesday statement that a single vial of the eye drop, which is designed to last about a month, will cost Rs 345 in the retail market.
Nikhil Masurkar, Chief Executive Officer of Entod Pharmaceuticals, told that the eye drop’s launch in India is a result of extensive research that started in 2019, while talking to media.
Pilocarpine hydrochloride ophthalmic solution, a prescription eye drop, works by stimulating the muscles in the eye to constrict the pupil, which helps improve near vision. The drug, a recent innovation in the treatment of presbyopia, thus provides a non-surgical option for individuals who experience difficulty focusing on close objects due to aging.
The medication is typically used once daily, and its effects can last for several hours. However, it is important for users to follow their healthcare provider’s instructions regarding dosage and administration to achieve the best results.
The original brand of Pilocarpine hydrochloride –Vuity – owned by US drug maker Allergan, was first launched in the US by this company, currently part of AbbVie, a global pharmaceutical company known for its range of eye care products, in 2021. The U S Food and Drug Administration (FDA) had cleared this for treating presbyopia in the same year.
Data from phase 3 clinical trials of the drug—carried out in 250 patients across 10 sites in India showed that it works best in people aged 40 to 55 years with mild-to-intermediate presbyopia, temporarily correcting vision problems.
The company claimed that the drug starts working within 15 minutes of application but complete benefits are likely to be visible after 15 days of use.
Pharmacologists and ophthalmologists say that for patients with presbyopia, Pilocarpine hydrochloride offers a non-invasive option that can enhance near vision without the need for reading glasses.
The recommended dosage for PresVu eye drop is one drop in each eye once daily. Studies are currently in process to evaluate multiple-doses per day. Any contact lens that is being worn should be removed prior to drop administration. After administration, the solution begins to have an effect within 15 minutes and provides a sharper near image for 6 to 10 hours.