Drugs authority suspends nod to firm for eye drops

The Central Drugs Standard Control Organisation (CDSCO) on Wednesday suspended the permission given to Entod Pharmaceuticals to manufacture and market its product PresVu for the treatment of Presbyopia in adults amid safety concerns.

The company last week claimed in a press statement that “PresVu is the first eye drop in India designed to reduce the need for reading glasses...” Presbyopia is an age-related vision condition that typically affects those above 40, causing difficulty in focusing on close objects. Last week, CDSCO sought an explanation from the manufacturer about its claims. Drug Controller General Dr Rajeev Singh Raghuvanshi said the company tried to justify the claims for the product for which no approval was granted.

Entod Pharmaceuticals said: “All facts disclosed to the media are strictly on the basis of the recent DCGI approval for treatment of presbyopia and the results of the phase-3 clinical trial conducted by us in India... claims that these can eliminate the need for reading glasses or used for other eye conditions is not the opinion of the company.”