Govt suspends license of PresVu wonder eye drops which claimed to replace reading glasses

The Drug Controller General of India has suspended the licence for PresVu, an eye drop by Entod Pharmaceuticals, due to unauthorised promotion. The eye drop claims to reduce the need for reading glasses in people with Presbyopia. Entod Pharmaceuti...

Agencies
The Drug Controller General of India (DCGI) has suspended the license for PresVu, an eye drop by Entod Pharmaceuticals meant to reduce the need for reading glasses in people with Presbyopia.

Government sources said the suspension was due to the company’s unauthorized promotions, creating doubts about the product's safety and its misuse by patients. "The promotion had raised concern about its use like OTC drugs whereas it is approved as a prescription-only drug," government sources said.

Entod Pharmaceuticals denied any unethical promotion and plans to challenge the suspension in court. In a statement, the company said, “Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen's chart which is yardstick of near vision impairment.”


The company also noted that similar eye drops with the same active ingredient and concentration have been approved by the US FDA and marketed in the US for the last three years without serious complications.
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