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Journalism of Courage
Mumbai-based Entod Pharmaceuticals announced in early September that the Drug Controller General of India (DCGI) — the country’s apex drug regulator — approved its new eye drop, which has been “specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia.”
However, a few days later, the DGCI suspended the manufacturing and marketing licence for the PresVu eye drop, saying Entod Pharmaceuticals had made misleading claims. The order from the DCGI said that the company “failed to respond to queries… (and) tried to justify the claims for the product for which no approval was granted.” The DCGI clarified that while the drop was approved for presbyopia, it was not approved for any claims that it can enhance vision without the need for reading glasses.
Entod Pharmaceuticals said it would challenge the orders of the drug controller. According to the company, the eye drop was the first of its kind in India, and Entod “applied for a patent for this invention in terms of its formulation and the process”.
Presbyopia is an age-related condition in which the eyes gradually lose the ability to focus on nearby objects. People usually start to develop presbyopia at around the age of 40. According to doctors, spectacles are one of the most effective ways to manage the condition.
The active ingredient — chemical compounds in medicines that have an effect on the body — in PresVu is pilocarpine. The compound contracts the iris muscles, which control the size of the pupil and help humans see things clearly, thereby enabling one’s eyes to focus better on nearby objects, according to Entod Pharmaceuticals.
The company also said that PresVu uses “advanced dynamic buffer technology” — essentially, a base solution — to adapt to the pH level (a scale used to measure how acidic or basic a substance is) of tears. This ensures that the eye drop has “consistent efficacy and safety for extended use, keeping in mind that such drops will be used for years at a stretch”.
PresVu is a prescription-only medicine and, according to doctors, its impact is unlikely to last beyond four to six hours. It should not be used by people who have inflammation of the iris. Regular use of PresVu may lead to itching and redness, eyebrow pain, and muscle spasms in the eyes.
Is this a novel therapy?
Although Entod’s claims make it seem that PresVu is a new therapy, pilocarpine, the main compound used in the eye drop, has been available in India for decades now.
Speaking to The Indian Express, Dr Mahipal Sachdeva, chairman of Centre for Sight, a chain of eye hospitals and clinics in India, said, “While pilocarpine has been in use as the first line therapy for cataract, its property of temporarily improving the depth of focus is something that has been known for quite some time.The drug has been tried for presbyopia in other countries as well”.
The United States Food and Drug Administration approved a pilocarpine eye drop for presbyopia in 2021.
In India, the government decides on the ceiling price of pilocarpine in 4% and 2% concentrations. PresVu has pilocarpine in 1.25% concentration.
