BREAKING: PresVu Alternative to Glasses in Presbyopia Not Accurate, DCGI Suspends Permission

New Delhi: Days after Mumbai-based Entod Pharmaceuticals' claimed that their new eye drops could reduce the need for reading glasses in people with presbyopia, the DCGI has suspended the company's permission to manufacture and sell the product. Presbyopia, according to the National Eye Institute, is a refractive error that makes it difficult for middle-aged and older adults to see close objects.

The drug regulator stated that the company made claims about the drug without approval from the Central Licensing Authority, violating the New Drugs and Clinical Trial Rules, 2019.

In an order dated September 10, the Drugs Controller General of India (DCGI) noted that permission had been granted on August 20 for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for treating presbyopia in adults.

On September 4, the drug regulator requested an explanation from the company regarding its claims made in the press. The drug-maker subsequently submitted its response.

In response to the claim "first eye drop in India designed to reduce the need for reading glasses", the order stated that the company said there are currently no other eye drops approved for the treatment of presbyopia in India. "In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses," the order said.

In response to the claim "this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses", the company submitted that in the clinical trial conducted, subjects did not wear glasses to participate.

"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 pc w/v 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," the order said.

In response to the claim "PresVu can provide an advanced alternative that augments near vision within 15 minutes", the firm in its response stated that one doctor has evaluated the drug product as compared to reading glasses.

"In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 pc w/v is approved for the treatment of Presbyopia in adults and is not approved for such claim that PresVu can provide an advanced alternative that augments near vision within 15 minutes," the order read.

The drug regulator stated that the company has failed to respond to the queries and tried to justify the claims for the product for which no approval was granted. It said, "...whereas it is clear that you have not obtained any prior approval from the Central Licensing Authority to make such claims for the said drug product as mentioned above. Thus, you have violated the condition No. (vi) of the permission dated 20.08 2024 issued to you for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v under the provisions of the New Drugs and Clinical Trials Rules, 2019.

The order further said considering the various media reports, there is a likelihood of the general public being misled by the claims made by the company for which no approval was granted.

"In view of above and considering the public interest, the permission issued to manufacture and market of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v vide is hereby suspended till further orders under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019 of the Drugs and Cosmetics Act, 1940," the order stated.