The Drug Controller General of India (DCGI) has suspended the permission granted earlier to Entod Pharmaceuticals for PresVu, an eyedrop designed to treat Presbyopia among people, following their claims that it can help in reducing dependency on reading glasses. The Drug regulator said the company had not obtained any approval from the Central Licensing Authority for the drug product, which is considered a violation of the New Drugs and Clinical Trail Rules 2019.

What is PresVu?

Earlier in August, the CEO of Entod Pharmaceuticals, Nikhil K Masurkar presented PresVu as a revolutionary treatment for Presbyopia. This medication was developed by the company for individuals between the age group of 40-55 years, suffering from mild to moderate presbyopia. PresVu was developed to enhance the vision and the quality of life for people. It was all set to launch in India during the first week of October with a price Rs 345 per vial.

Source: Nikkhil K Masurkar

DGCI issues an order suspending PresVu: Here’s what the order reads

In an order issued on September 10, the DGCI said the director had approved on August 20 the production and distribution of Pilocarpine Hydrochloride Ophthalmic solution for the treatment of adult presbyopia among adults.

On September 4, the drug regulator requested an explanation from the company about the statements it had made in the media about the product, to which the manufacturer submitted its request.

In response to their claim, “India’s first eyedrop 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 percent w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses,” the order noted.

Further, in response to another claim, this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses”. The company submitted that during 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. It is not approved for such claim that PresVu can provide an advanced alternative that augments near vision within 15 minutes.”

The Order

PresVu failed to respond

Meanwhile, the drug regulator said that the company has failed to respond to the queries and tried to present justify claims for the product which is not approved officially.

In addition to this, the Public is being misled by the claims of the company which has no approval. The drug regulator announced its suspension under the provisions of Rule 84 of the New Drugs and Clinical Trails Rules 2019 of the Drugs and Cosmetics Act 1940.

What is Presbyopia and Symptoms?

Presbyopia is a common age-related condition where there is a gradual loss of one’s vision to focus on nearby objects. The condition typically happens during the mid-40s and continues to progress until the age of 65. Some common symptoms of Presbyopia involve Blurred vision, eye strain, or headache after prolonged close-ups, etc.