US FDA Approval and the DCGI Suspension of PresVu Eye Drops for Presbyopia

Wednesday, 11 September 2024, 22:38

US FDA regulations impact the suspension of PresVu eye drops by DCGI, aimed at treating presbyopia. The product, produced by Entod Pharmaceuticals, faced scrutiny over unauthorized promotions. Despite the suspension, the company defends the efficacy shown in clinical trials using Snellen's chart for near vision impairment assessment.
Indiatimes
US FDA Approval and the DCGI Suspension of PresVu Eye Drops for Presbyopia

US FDA Approval and DCGI's Actions

The Drug Controller General of India (DCGI) has recently suspended the license for PresVu, an eye drop produced by Entod Pharmaceuticals, intended to alleviate the reliance on reading glasses for patients suffering from presbyopia. This action stems from concerns about the company's unauthorized promotions, casting doubt on the safety of the product and leading to potential misuse.

Background on PresVu

Government sources revealed that the promotion of PresVu raised alarms similar to those associated with OTC drugs, despite its approval as a prescription-only medication. In response to these allegations, Entod Pharmaceuticals remains steadfast, intending to contest the suspension in court.

Clinical Evidence and FDA Comparison

In a statement, Entod Pharmaceuticals emphasized that their approval from DCGI was based on a valid controlled clinical trial involving 234 patients, demonstrating both the safety and efficacy of PresVu for individuals with presbyopia. These patients reported improved vision and were able to read additional lines on the Snellen's chart, a standard measure of near vision impairment.

Furthermore, similar eye drops with the same active ingredient and concentration have received US FDA approval and have been marketed in the US for over three years without any serious complications.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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