PRESBYOPIA (Syllabus: GS Paper 3 – Sci and Tech)

Context: Entod Pharmaceuticals, based in Mumbai, has received approval from the Drug Controller General of India (DCGI) for its new eye drop, designed to reduce dependency on reading glasses for those with presbyopia.

Presbyopia

• About: It is an age-related condition in which the eyes gradually lose the ability to focus on nearby objects.
• Onset: It typically starts around the age of 40.
• Management: Spectacles are one of the most effective ways to manage the condition.
• How Does PresVu Work?

oActive Ingredient: PresVu contains pilocarpine, which is a chemical compound that affects the body by contracting the iris muscles.

oMechanism: Pilocarpine helps improve focus on nearby objects by controlling the size of the pupil.

oTechnology: PresVu uses “advanced dynamic buffer technology” to adapt to the pH level of tears, ensuring consistent efficacy and safety for extended use.

oPrescription Status: PresVu is available by prescription only.

oDuration of Effect: The impact of PresVu is generally effective for four to six hours.

oSide Effects: Potential side effects include itching, redness, eyebrow pain, and muscle spasms in the eyes.

oHistorical Use: Pilocarpine has been used for cataract therapy and is known to temporarily improve the depth of focus. It has been tried for presbyopia in other countries as well.

• Regulatory Information:

oFDA Approval: The United States Food and Drug Administration approved pilocarpine eye drops for presbyopia in 2021.

oPrice Regulation: In India, the government regulates the ceiling price for pilocarpine in 4% and 2% concentrations, while PresVu contains pilocarpine in a 1.25% concentration.