J&J Granted FDA Approval for Monofocal IOL

The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson Vision’s TECNIS Eyhance and TECNIS Eyhance Toric II intraocular lens (IOL) for cataract patients in the U.S. The first implantation of TECNIS Eyhance IOL in the U.S. will occur in Texas next week.
 
Over 90 percent of people develop cataracts by the age of 65.² Left untreated, cataracts cause vision to deteriorate over time. They are the leading cause of preventable blindness worldwide, impacting more than 100 million eyes.³ Cataract surgery is one of the most common outpatient procedures, with a success rate of aabout 98 percent.⁴ Cataract treatments can also help correct vision in addition to removing the cataract, reducing or eliminating the need for glasses.^5,6
 
“84 percent of surgeons⁷ choose monofocal IOLs for their cataract patients, so it’s thrilling to see the first breakthrough in monofocal technology in decades enter the market to add to our treatment portfolio,” Douglas Koch, M.D., Houston, Texas commented in a press release. “It’s the first monofocal designed to provide a slight increase in the depth of focus,^1,8 which is something I need for the patients in my practice looking for more from a monofocal.”
 
The latest innovation in the TECNIS Family of IOLs—TECNIS Eyhance and TECNIS Eyhance Toric II IOLs—have a breakthrough refractive surface designed to:
 
Slightly extend the depth of focus¹ through the unique shape of the lens
Deliver better image contrast in low light⁹ TECNIS Eyhance IOLs deliver 30 percent improvement in image contrast compared to AcrySof IQ SN60WF at 5mm
Provide safe and easy delivery using the new TECNIS Simplicity system that streamlines lens delivery and protects against contamination¹⁰
 
“Built on the proven TECNIS platform,¹¹ TECNIS Eyhance combines low-light performance with breakthrough refractive surface design, providing a new kind of monofocal experience for cataract patients,¹²” said Rajesh K. Rajpal, MD, chief medical officer and global head of clinical and medical affairs at Johnson & Johnson Vision. “Additionally, the TECNIS Eyhance Toric II lens is engineered with a new squared and frosted haptic design for added friction inside the capsular bag to treat cataract patients with astigmatism.”
 
“We consistently engage with our surgeons and their patients to better understand their unmet needs, and their feedback drove us to innovate and push the boundaries of the monofocal category—a category that’s largely been stagnant for the last 20 years,” said Sandor Palfi, Commercial Vice President of the Americas at Johnson & Johnson Vision. “TECNIS Eyhance IOL is built on the foundation of our proven TECNIS platform, designed to deliver more.”
 
TECNIS Eyhance first launched in Europe in February 2019 and became commercially available in Latin America and Canada in the summer of 2020. TECNIS Eyhance and TECNIS Eyhance Toric II are now commercially available in the U.S., with TECNIS Eyhance Toric II launching in Europe and Canada later this year.
 
References
¹ Data on file. Eyhance DFU. The TECNIS Eyhance IOLs are designed to slightly extend the depth of focus compared to the TECNIS 1-Piece IOL, Model ZCB00 as measured in bench testing.
² Kellogg Eye Center. Cataract. https://www.umkelloggeye.org/conditions-treatments/cataract.
³ World Health Organization. Blindness and Impairment. https://www.who.int/en/news-room/fact-sheets/detail/blindness-and-visual-impairment
⁴ Vision Health Initiative, Common Eye Disorders. Centers for Disease Control and Prevention. https://www.cdc.gov/visionhealth/basics/ced/index.html
⁵ All About Vision. Will I Need Glasses After Cataract Surgery? https://www.allaboutvision.com/conditions/faq-cataract-glasses-after-surgery.htm
⁶ Khandelwal SS, et. al. Effectiveness of multifocal and monofocal intraocular lenses for cataract surgery and lens replacement: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):863-875. doi: 10.1007/s00417-018-04218-6.
⁷ Market Scope 2020 Global IOL Report.
⁸ Data on file. Eyhance DFU.
⁹ Data on file. Johnson & Johnson Surgical Vision, Inc. 2021.
¹⁰ TECNIS Monofocal IOL with TECNIS Simplicity Delivery System (package insert, DFU DCB00 (Z311063P Rev. D).
¹¹ The safety and effectiveness of the TECNIS Eyhance IOL has not been substantiated in clinical trials. The effects of the TECNIS Eyhance IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances have not been evaluated clinically.
¹² Data on file, Johnson & Johnson Surgical Vision, Inc. 2021.