FDA gives LensGen IDE approval to start presbyopia-correcting IOL study
LensGen received approval from the U.S. Food and Drug Administration to start a pivotal study of the Juvene intraocular lens (IOL) for patients with cataracts, according to a company press release.
The IOL is modular and has a fluid optic component that changes shape to adjust focus.
“We are proud to achieve this significant milestone for the company, which allows us to move forward with the IDE pivotal trial with the ultimate goal of seeking premarket approval in the largest eye care market in the world,” said Ramgopal Rao, LensGen Chief Executive Officer in the press release. “Achieving IDE approval of a novel device is a tremendous undertaking and enormous accomplishment for the company, and we are grateful to the FDA for their rigorous and insightful guidance throughout the process.”
Eric Donnenfeld, MD, Clinical Professor in the Department of Ophthalmology at the New York University Grossman School of Medicine and Founding Partner of Ophthalmic Consultants of Long Island added: “Based on the Grail Study clinical data and my direct experience with surgery and observations of the patients implanted with Juvene IOL, LensGen technology has the potential to provide a significant new and superior option to our patients.”
Read the full press release here.