Lumenis Ltd., the world’s largest energy-based medical device company for ophthalmic, aesthetic and surgical applications and the inventor of intense pulsed light (IPL) technology, today announced that the FDA has granted De Novo authorization for Lumenis’ newest IPL device for improving signs of dry eye disease due to meibomian gland dysfunction (MGD).
Dry eye disease is a common disorder that causes dry, gritty, burning, tired eyes and fluctuating vision. About 16 million Americans have been diagnosed,1 and twice as many may be undiagnosed with dry eye. MGD is the leading cause of dry eye disease, accounting for about 86% of cases.2
The Lumenis multi-center, double-blinded, randomized controlled FDA trial showed that Lumenis IPL with patented Optimal Pulse Technology (OPT®) significantly improved tear breakup time, meibum quality, and meibomian gland expressibility.3 The clinical trial joins a long list of studies of Lumenis’ IPL with OPT® that have shown the same results, as well as reduction of inflammatory markers.4-7
Subsequent to the FDA approval, Lumenis is launching OptiLight™, a bright solution for dry eyes. OptiLight™ with Lumenis’ patented OPT® technology is designed for a consistent, precise, and controlled light-based treatment of signs of dry eye disease.
“We deal with dry eye every day, but unless we address the underlying inflammation, it’s difficult to meaningfully impact the disease. OptiLight™ helps us to address the inflammation, as shown in Lumenis’ IPL clinical trials, and improves signs of dry eye disease due to MGD, positioning it as a valuable tool in our dry eye toolkit,” said Dr. Steven J. Dell, medical director of Dell Laser Consultants and lead investigator in the Lumenis’ clinical trial submitted to the FDA.
“Lumenis has launched many ‘firsts’ in eye care, and we never stop innovating. This is why we are excited that our IPL device with patented OPT® technology is the first and only such device to receive FDA approval for improving signs of dry eye disease. We’re exceptionally proud to elevate dry eye management and to improve the quality of life for millions of patients,” said Lumenis CEO Tzipi Ozer-Armon. “We are proud to launch OptiLight™️, a light-based system that provides doctors with a safe and effective dry eye procedure to add to their toolkit. We look forward to continued collaboration with doctors across the U.S. and globally in elevating dry eye care.”
Lumenis will unveil the new OptiLight™ at a formal virtual launch event on May 13, 2021, 7 p.m. EDT. Register at: www.lumenis.com/optilight.