India’s drug regulator has suspended approval for PresVu, an eye drop claiming to reduce dependence on reading glasses, citing unauthorised promotion and safety concerns. The company, Entod Pharmaceuticals, has challenged the decision, arguing their claims are based on US FDA approval and successful clinical trials.
India’s drug regulator has suspended the approval granted to Entod Pharmaceutical Ltd. to manufacture PresVu eye drops, citing the company’s unapproved claims that the drops reduce dependency on reading glasses. The regulator raised concerns about the safety of the eye drops and their over-the-counter use, as they were approved as a prescription drug. Entod Pharmaceuticals has disputed the suspension and plans to challenge the order in court.
PresVu, an eye drop developed by Entod Pharmaceuticals in India, has been approved by the Drug Controller General of India (DCGI) and will be available in the market soon. This innovative treatment aims to eliminate the need for reading glasses in individuals aged 40 to 55 with presbyopia, a natural age-related condition that affects the eye’s ability to focus on nearby objects. PresVu is the first of its kind in India and offers a viable alternative to traditional interventions like reading glasses.
