Taking serious note of Mumbai-based Entod Pharmaceuticals’ claims that it can help reduce dependency on reading glasses for those suffering from presbyopia, the Drugs Controller General of India has suspended the permission granted to manufacture and sell their new eye drops.
According to the National Eye Institute, presbyopia is a refractive error that makes it hard for middle-aged and older adults to see things up close.
The drug regulator said the company made claims for the drug product for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.
In an order issued on September 10, the Drugs Controller General of India (DCGI) said the Directorate had issued permission on August 20 for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults.
Then on September 4, the drug regulator had asked for an explanation from the company for the claims it made in the press following which the drug-maker also 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 that “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 drops 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 had 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 had failed to respond to the queries and tried to justify the claims for the product for which no approval was granted.