The US Food and Drug Administration (FDA) has granted an approval for LensGen’s investigational device exemption (IDE) application to begin a clinical study of the Juvene intraocular lens (IOL).
LensGen has designed the pivotal trial to assess Juvene presbyopia-correcting intraocular lens in patients with cataracts.
Presbyopia, a common and age-related vision condition, makes people difficult to focus on things up close.
The Juvene IOL has been designed for the permanent restoration of clear and continuous vision at all distances, including near and intermediate.
The lens, which is modular, features a fluid optic component that holds the potential to change shape for the adjustment of focus ranging from viewing mobile devices and computer screens to quality distance vision in different lighting conditions.
According to the company, the lens is implanted using the same surgical techniques utilised for traditional intraocular lenses.
LensGen CEO Ramgopal Rao said: “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.
“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.”
At present, the company is under the process of raising a series B financing that is anticipated to be completed in the first half of next year.
LensGen is focused on the development of capsule filling intraocular lens platform and fluid-lens, which mimics the human lens.
