Intraocular lens developer LensGen announced today that it received FDA investigational device exemption (IDE) for its Juvene lens.
Irvine, California-based LensGen designed the Juvene intraocular lens (IOL) for patients with cataracts, with the IDE set to initiate a pivotal study for the device.
The company developed Juvene IOL t0 permanently restore clear and continuous vision at all distances, including near and immediate. The lens is modular and has a fluid optic component designed to change shape to adjust focus on demand for active lifestyles.
Additionally, the lens offers improved viewing for mobile devices and computer screens, as well as distance vision in a wide range of lighting conditions. LensGen said that the lens is implanted using the same surgical techniques as with traditional IOL devices.
LensGen noted that it is currently in the process of raising a Series B financing round, with expectations of closing that funding in the first half of 2022.
“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 Rao said in the 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.”