IRVINE, Calif., Nov. 29, 2021 /PRNewswire/ — LensGen, Inc., a privately held ophthalmic medical device company, announced today that it 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 intraocular lens (IOL) for patients with cataracts.
The LensGen Juvene IOL is designed to permanently restore clear and continuous vision at all distances including near and intermediate. The lens is modular and has a fluid optic component that changes shape to adjust focus on demand for today’s active lifestyles, from viewing mobile devices and computer screens to high-quality distance vision in a broad range of lighting conditions. 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,” said Ramgopal Rao, LensGen Chief Executive Officer. “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, 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.
LensGen is currently in the processing of raising a Series B Financing expected to close in the first half of 2022.
LensGen, Inc., is a privately held ophthalmic medical device company that develops breakthrough technologies to improve vision and improve the lives of patients. Through its pioneering efforts to develop a versatile, capsule filling intraocular lens platform and fluid-lens that mimics the natural human lens, the company aims to restore youthful vision to millions of cataract and presbyopia patients around the world.
A cataract is a cloudy area in the natural lens of the eye that affects vision. As a cataract develops, the eye’s lens gradually becomes hard and cloudy allowing less light to pass through, which makes it more difficult to see. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness.1 More than four million cataract surgeries are performed each year in the U.S., and projected to increase by more than 16 percent by the end of 2024. The presbyopia correcting IOL market is expected to grow 60 percent by the end of 2024.2
Presbyopia is a common, age-related vision condition in which people have difficulty focusing on things up close. It involves the gradual loss of the eye’s ability to focus on close objects, such as smart phones, computers, books, and menus. Everyone will experience presbyopia as they age, with symptoms often first appearing as an individual enters their forties and continues to worsen into their sixties.3 In the U.S., an estimated 112 million people experience vision issues due to presbyopia.4
Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.
1. Centers for Disease Control and Prevention, Vision Health Initiatives. Available at: https://www.cdc.gov/visionhealth/basic/ced/index.html
2. Market Scope. 2019 IOL Market Report
3. Mayo Clinic, Presbyopia. Available at: https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328.
4. American Optometric Association: Optometric Clinical Practice Guidelines, Care of the Patient with Presbyopia. Available at: https://www.aoa.org/documents/optometrists/CPG-17.pdf