Drug regulator suspends nod for Entod Pharma's eye drops which claim to 'reduce need for glasses'

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

Etod Pharmaceuticals had last week claimed that PresVu is the first eye drop in India designed to reduce the need for reading glasses and also there are currently no other eye drops approved for the treatment of Presbyopia in India.

Last week, CDSCO sought an explanation from the manufacturer about its claims.

CDSCO also said the manufacturer claimed in its statement that the product can be used without prescription wherein it was permitted to be used only after prescription by doctors.

In its order, CDSCO said, “In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution is approved for the treatment of Presbyopia in adults and is not approved for such claim that these eye drop can enhance near vision without the need for reading glasses.”

In its report to the CDSCO the pharmaceuticals also said that during the clinical trial of the product the “subjects did not wear glasses to participate”.

The manufacturer also claimed that the eye drop offers an advanced alternative that augments near vision within 15 minutes. CDSCO also said that the drug was not approved for any such claim.

“After a perusal of your reply, it is clear that you had failed to respond to the queries as put to you. You had tried to justify the claims for the product for which no approval was granted.

“And also, whereas it is clear that you have not obtained any prior approval from the Central Licencing Authority to make such claims for the said drug product as mentioned above. Also considering the various media reports, there is a likelihood of the general public being misled by the claims made by you, for which no approval was granted,” CDSCO said in its order.