The approval will allow LensGen to move forward with the IDE pivotal trial with the ultimate goal of seeking premarket approval in the United States.
LensGen Inc. has received approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal study of the company's Juvene IOL for patients with cataracts.
The Juvene IOL (LensGen Inc.) is a new modular, shape-changing, fluid optic IOL designed to behave like the natural crystalline lens. It is designed to permanently restore clear and continuous vision at all distances including near and intermediate. The lens is implanted using the same surgical techniques used with traditional intraocular lenses.
"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," LensGen CEO Ramgopal Raosaid in a statement. "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."
"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, 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.
The Grail investigators, led by Donnenfeld, conducted an exploratory study of the Juvene IOL in which patients underwent small-incision cataract surgery followed by IOL implantation.
The primary outcomes evaluated were the best-corrected distance visual acuity (CDVA), distance-corrected intermediate VA (DCIVA), distance-corrected near (DCNVA), and defocus curves.
LensGen is currently in the processing of raising a Series B Financing expected to close in the first half of 2022.
RELATED: Grail Study shows refractive stability of Juvene IOL