Drug agency suspends approval for eye drops that supposedly replace reading glasses

India's drug regulator took seriously claims by Mumbai-based Entod Pharmaceuticals that it could help reduce dependence on reading glasses for presbyopia and withdrew approval to manufacture and sell the company's new eye drops.

According to the National Eye Institute, presbyopia is a refractive error that makes it difficult for middle-aged and older adults to see things up close.

The drug regulator said the company had made claims about the drug without obtaining approval from the central regulatory authority, thereby violating the provisions of the New Drugs and Clinical Trial Rules, 2019.

In an order issued on September 10, the Drugs Controller General of India (DCGI) said that the directorate had granted approval on August 20 for the manufacture and marketing of an ophthalmic solution containing pilocarpine hydrochloride for the treatment of presbyopia in adults.

On September 4, the drug agency then asked the company to respond to the allegations made in the press, whereupon the drug manufacturer also submitted a response.

In response to the claim of being “first eye drops in India to reduce the need for reading glasses”, the order said the company had informed that there are currently no other eye drops approved in India for the treatment of presbyopia.

“In this regard, you are informed that Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 percent w/v has not been approved for the claim of reducing the need for reading glasses,” the order said.

In response to the claim that “these eye drops provide a non-invasive way to improve near vision without the need for reading glasses,” the company stated that the subjects did not wear glasses during the clinical study conducted.

“In this regard, you are informed that Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 pc w/v is approved for the treatment of presbyopia in adults and not for the claim that these eye drops can improve near vision without the need for reading glasses,” the order said.

In response to the claim “PresVu may provide an advanced alternative that improves near vision within 15 minutes,” the company stated that a doctor had evaluated the drug in comparison to reading glasses.

“In this regard, you are informed that Pilocarpine Hydrochloride Eye Drop Solution USP 1.25 pc w/v is approved for the treatment of presbyopia in adults and not for the claim that PresVu can provide an advanced alternative that improves near vision within 15 minutes,” the order states.

The drug agency said the company did not respond to requests and attempted to substantiate the advertising claims for the product, which had not been approved.

“It is evident that you have not obtained prior approval from the Central Regulatory Authority to make the above claims for the said drug. Therefore, you have violated the condition no. (vi) of the approval dated 20.08.2024 granted to you for manufacturing and marketing Pilocarpine Hydrochloride Eye Drops Solution USP 1.25% w/v under the provisions of the New Drugs and Clinical Trials Rules, 2019,” the order said.

The order further states that in view of the various media reports, there is a likelihood that the public will be misled by claims made by the company for which no authorization has been granted.

“In view of the above and keeping in view the public interest, the authorisation granted to manufacture and market Pilocarpine Hydrochloride Eye Drops Solution USP 1.25% w/v is suspended until further notice under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019 of the Drugs and Cosmetics Act, 1940,” the order said.