LensGen, a privately held ophthalmic medical device company, announced that the US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to initiate a pivotal trial of its Juvene intraocular lens (IOL) for cataract patients.
The LensGen Juvene IOL is designed to restore clear and continuous vision throughout a wide range of distances, including near and intermediate. The lens is modular, with a fluid optic component that adjusts focus on demand, for seeing mobile devices and computer screens to high-quality distance vision in a variety of lighting conditions. The lens is implanted using the same surgical techniques used with traditional IOLs.
“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.
“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,” said Eric Donnenfeld, M.D., 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.