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FDA Approves Alcon's AcrySof IQ PanOptix Trifocal IOL, the First Trifocal Lens

FDA Approves Alcon's AcrySof IQ PanOptix Trifocal IOL, the First Trifocal Lens

PanOptix delivers an exceptional combination of near, intermediate, and distance vision and substantially reduces the need for glasses.

By Business Wire08.27.19
Alcon announced the Food and Drug Administration (FDA) approval and its initial commercial launch of AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL), the first and only trifocal lens for U.S. patients undergoing cataract surgery. PanOptix is clinically shown to deliver an exceptional combination of near, intermediate and distance vision while significantly reducing the need for glasses after surgery.1,2
 
PanOptix is already one of the leading presbyopia-correcting IOLs in more than 70 countries. It is designed for today’s active lifestyles, from viewing mobile devices and computer screens to high-quality distance vision in a range of lighting conditions. The new lens uses ENLIGHTEN Optical Technology, a proprietary design that optimizes intermediate vision without compromising near and distance vision. Available in spherical and toric designs, PanOptix is built on Alcon’s proven AcrySof IQ IOL platform that has been implanted in more than 120 million eyes globally.
 
“We are proud to bring this new class of IOLs to the largest eye care market in the world,” said David J. Endicott, CEO of Alcon. “We are leveraging Alcon’s years of experience with PanOptix in other countries to provide the best possible training and support for U.S. surgeons. Our goal is to ensure optimal outcomes for cataract patients looking to correct their vision at all distances, with the vast majority of them never needing to wear glasses post-surgery.”
 
The FDA approval of PanOptix was based on a pivotal study at 12 investigational sites in the U.S. With this single trifocal lens design, PanOptix patients demonstrated exceptional, uninterrupted vision. The results also showed high patient satisfaction with more than ninety-nine percent of PanOptix patients saying they would choose the same lens again.1


 
More than 4 million cataract surgeries are performed each year in the U.S., which is projected to increase by more than 16 percent by the end of 2024.3,4 The presbyopia-correcting IOL market is expected to grow 60 percent by the end of 2024.4
 
“The U.S. ophthalmology community has been eagerly awaiting FDA approval of PanOptix. While participating in the clinical trial, I saw first-hand the impact of this lens on my patients,” said Kerry Solomon, M.D., Carolina Eyecare Physicians, PanOptix clinical trial investigator. “We know patients undergoing cataract surgery today want a replacement lens that delivers the vision they need to live full, active lives without always being dependent on glasses. PanOptix is an excellent lens option to address these needs and is clinically proven to deliver an outstanding range of vision.”
 
Alcon plans to begin training U.S. ophthalmologists and making inventory of PanOptix and PanOptix Toric IOLs available through the rest of 2019 into early 2020. As part of its patient education efforts, the company will soon launch a dedicated PanOptix website and multimedia awareness campaign. A similar effort is planned for eye care professionals with special launch activities slated for the annual meeting of the American Academy of Ophthalmology in October.
 
References
1 AcrySof IQ PanOptix Directions For Use. 
2 Compared to AcrySof monofocal IOL. 
3 Market Scope. 2017 Ophthalmic Surgical Instrument Report. 
4 Market Scope. 2019 IOL Market Report. April 2019. 
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