Johnson & Johnson Vision Receives FDA Approval For Next Generation Monofocal Intraocular Lens - TECNIS Eyhance™ And TECNIS Eyhance™ Toric II IOLs - For The Treatment Of Cataract Patients
SANTA ANA, Calif., Feb. 2, 2021 /PRNewswire/ -- Johnson & Johnson Vision**, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies***, today announced that the U.S. Food and Drug Administration (FDA) approved the TECNIS Eyhance™ and TECNIS Eyhance™ Toric II intraocular lens (IOL) for the treatment of cataract patients in the United States. With this approval and subsequent commercial launch, ophthalmologists in the U.S. now have the ability to choose this next generation monofocal as the lens of choice for their patients with or without astigmatism. The first implantation of TECNIS Eyhance IOL in the U.S. will happen in Texas next week.
More than 90% of people develop cataracts—the clouding and yellowing of the lens in the eye—by the age of 65.2 While part of the normal aging of the eye, left untreated, cataracts cause vision to deteriorate over time. In fact, cataracts 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 performed today and has a success rate of approximately 98%.4 Today, cataract treatments can also offer patients vision correction, reducing or eliminating the need for glasses, in addition to removing the cataract.5,6
"84% 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," said Douglas Koch, M.D., Houston, TX****. "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 – is defining the future of monofocals, with a breakthrough refractive surface designed to:
"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."
The TECNIS Eyhance IOL is the latest lens in the TECNIS Family, which celebrates its 20th anniversary this year. The TECNIS Family portfolio is the broadest mix of IOLs for cataract patients in need of monofocals, multifocals, extended depth of focus (EDOF), and those with or without 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.
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About Johnson & Johnson Vision**
About Johnson & Johnson Medical Devices Companies***
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance™ and TECNIS™ Eyhance Toric II IOLs with TECNIS Simplicity® Delivery System
INDICATIONS FOR USE
The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS Eyhance™ Toric II IOLs for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag.
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
* Compared to the TECNIS 1-PIece IOL, Model ZCB00 as measured in bench testing.
**Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
****Dr. Koch is a paid consultant of Johnson & Johnson Vision, Inc.
*****Dr. Rajesh K. Rajpal is an employee of Johnson & Johnson Surgical Vision, Inc., serving as Head of Clinical and Medical Affairs across both the Surgical Vision and Vision Care organizations.
******Sandor Palfi is an employee of Johnson & Johnson Vision, Inc., serving as Commercial Vice President of the Americas, with oversight of the U.S., Latin America and Canada regions.
© Johnson & Johnson Vision, 2021. All rights reserved.
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SOURCE Johnson & Johnson Vision