Entod Pharma meets DCGI, issues clarification over eye drop 'claims'

Move comes after drug regulator had suspended nod granted to firm to manufacture, sell PresVu eye drops

Mumbai-based Entod Pharmaceuticals has recently met the Drugs Controller General of India (DCGI) after the Central Drug Standards Control Organisation (CDSCO) suspended permission granted to the company to manufacture and sell its PresVu eye drops.

The step was taken after the drug regulatory body objected to the firm’s claim that the eye drops can help eliminate dependency on reading glasses for those suffering from presbyopia. Earlier this month, Entod had launched its PresVu eye drops, which are made using pilocarpine, an alkaloid used to treat various ophthalmological conditions, including presbyopia—an age-related condition that makes it difficult to see things up close.

Speaking about the recent meeting with the DCGI, Nikkhil K Masurkar, chief executive officer, Entod Pharmaceuticals, said that the company explained the situation regarding PresVu to the DCGI and clarified its intentions behind the media announcement.

“Entod fully understands the DCGI’s concerns and respects his decision to suspend the permission for PresVu eye drops following hyped claims in news reports,” he added. According to sources, health ministry officials had taken the matter seriously due to concerns over the potential misuse of the product. The company was alleged to have claimed that the drops could possibly replace reading glasses, with the onset of action occurring within 15 minutes of use.

“The unauthorised promotion in the press and over social media raised doubts about the product's safety and concerns about its use by the public. The promotion created the impression that it was an over-the-counter (OTC) drug, whereas it is approved as a prescription-only drug,” an official source told Business Standard.

Clarifying the issue behind the alleged claims, Masurkar stated that PresVu eye drops are not intended to replace reading glasses or non-invasive options for presbyopia. “It is a therapeutic option, available only by prescription from a registered medical practitioner, for patients diagnosed with presbyopia as assessed by an eye doctor,” he said.

Masurkar added that in explaining the treatment of presbyopia, the company had shared data from its Indian Phase 3 clinical trials regarding the 15-minute onset of action and the possibility of replacing reading glasses. “It appears that some of these explanatory statements were quoted out of context in certain news reports and were never intended to be claims of our company,” he said.

Officials indicate that Masurkar has also provided the DCGI with a written undertaking that Entod will fully comply with the conditions outlined in the permission for PresVu eye drops and make only approved claims.

“The company has appealed to the DCGI to reconsider the suspension of approval for PresVu eye drops,” an official added.

According to a company statement, Entod currently has over 150 ophthalmic formulations in the domestic market for various eye ailments and supplies to 67 countries globally. Its research and development (R&D) arm is also working on cutting-edge therapeutic treatments for myopia in children, glaucoma, corneal diseases, and retinal eye diseases.