Alcon (NYSE:ALC) said today that it won FDA approval for its AcrySof IQ PanOptix trifocal intraocular lens and is preparing an initial commercial launch for the device.
The Fort Worth, Texas-based company’s AcrySof IQ PanOptix device is the first and only trifocal device in the U.S. for patients undergoing cataract surgery. It’s designed to provide a combination of improved near, immediate and distance vision and significantly reduce the need for glasses after surgery.
FDA approval followed a U.S. pivotal study that revealed uninterrupted vision and high patient satisfaction (99%) from the PanOptix lenses, according to the company.
Alcon said it plans to begin training ophthalmologists and making inventory of its PanOptix products available through 2019 and into 2020. It also intends to launch a PanOptix website and incorporate activities for eye care professionals at the annual meeting of the American Academy of Ophthalmology in October.
“We are proud to bring this new class of IOLs to the largest eye care market in the world,” Alcon CEO David Endicott said in prepared remarks. “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 U.S. ophthalmology community has been eagerly awaiting FDA approval of PanOptix,” added clinical investigator Dr. Kerry Solomon of Carolina Eyecare Physicians. “While participating in the clinical trial, I saw first-hand the impact of this lens on my patients. 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.”
