DCGI Suspends License of PresVu Eye Drops for Presbyopia

Wednesday, 11 September 2024, 22:38

US FDA acknowledged the efficacy of eye drops despite DCGI's suspension of PresVu for Presbyopia. Entod Pharmaceuticals faces issues over unauthorized promotions. The drug was intended to reduce reliance on reading glasses, causing safety concerns among officials.
Indiatimes
DCGI Suspends License of PresVu Eye Drops for Presbyopia

Suspension of PresVu by DCGI

The Drug Controller General of India (DCGI) has suspended the license for PresVu, an eye drop produced by Entod Pharmaceuticals intended to diminish the necessity for reading glasses in individuals suffering from presbyopia. The suspension stems from the company's unauthorized promotions, which raised uncertainties about the product's safety.

Concerns Over Product Safety and Misuse

Sources within the government have expressed discontent over the promotional strategies utilized by Entod Pharmaceuticals, which incorrectly positioned PresVu as a non-prescription, over-the-counter (OTC) product. However, it has only been sanctioned for prescription use.

  • Unauthorized Promotion: Raised safety concerns.
  • Sued for suspension: Entod Pharmaceuticals plans legal actions.
  • Clinical Trials: DCGI approval stemmed from trials involving 234 participants showing efficacy.
  • Approved by US FDA: Similar eye drops have been marketed in the US without severe complications.

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