LensGen® Receives US FDA IDE Approval to Begin Clinical Study of Juvene® Presbyopia Correction Intraocular Lens
The LensGen Juvene IOL is designed to permanently restore clear, continuous vision at all distances, including near and intermediate. The lens is modular and has a fluid optical component that changes shape to adjust focus on demand of today’s active lifestyles, from viewing mobile devices and computer screens to high quality far vision in a wide range of lighting conditions. The lens is implanted using the same surgical techniques used with traditional intraocular lenses.
âWe are proud to have taken this important milestone for the company, which allows us to move forward with the IDE pivotal trial with the ultimate goal of obtaining pre-market approval in the larger market of eye care to the world, âsaid Ramgopal rao, CEO of LensGen. âObtaining IDE approval for a new device is a tremendous undertaking and a tremendous accomplishment for the company, and we are grateful to the FDA for their rigorous and insightful advice throughout the process.â
âBased on the clinical data from the Grail study and my direct experience of surgery and observations of patients implanted with Juvene IOL, LensGen technology has the potential to provide a significant and superior new option to our patients,â said declared Eric Donnenfeld, MD, clinical professor in the ophthalmology department of the New York University Grossman School of Medicine and founding partner of Ophthalmic Consultants of Long Island.
LensGen is currently in the process of raising Series B funding which is expected to close in the first half of 2022.
LensGen, Inc., is a privately held ophthalmic medical device company that develops cutting-edge technologies to improve the vision and 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 through worldwide.
A cataract is a cloudy area in the natural lens of the eye that affects vision. As cataracts develop, the lens of the eye gradually becomes hard and cloudy, allowing less light to pass through, making it harder to see. Cataracts are the most common age-related eye disease and the leading cause of preventable blindness.1 Over four million cataract surgeries are performed annually in the United States and are expected to grow over 16% by the end of 2024. The market for presbyopia correcting IOLs is expected to grow 60% by the end from 2024.2
Presbyopia is a common age-related eye condition in which people find it difficult to focus on things up close. It involves the gradual loss of the eye’s ability to focus on nearby objects, such as smartphones, computers, books, and menus. Everyone will experience presbyopia as they get older, with symptoms often first appearing when a person enters their 40s and continues to worsen into their 60s.3 In the United States, an estimated 112 million people suffer from vision problems due to presbyopia.4
Warning: investigation device. Limited by the federal government (or United States) for investigative use.
1. Centers for Disease Control and Prevention, Vision Health Initiatives. Available at: https://www.cdc.gov/visionhealth/basic/ced/index.html
2. Scope of the market. 2019 IOL Market Report
3. Mayo Clinic, Presbyopia. Available at: https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328.
4. American Association of Optometry: Optometric Clinical Practice Guidelines, Care of the Presbyopic Patient. Available at: https://www.aoa.org/documents/optometrists/CPG-17.pdf
Contact: Geline Atienza