GS Paper - III

Mumbai-based Entod Pharmaceuticals has announced that the Drug Controller General of India (DCGI) — the country’s apex drug regulator — has approved its new eye drop, which has been “specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia.”

The eye drop PresVu is the first of its kind in India, and has “applied for a patent for this invention in terms of its formulation and the process”.

What is presbyopia?

• 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.

How does PresVu work?

• 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.
• 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.