Lumenis announced that the FDA has granted De Novo authorization for Lumenis’ newest intense pulsed light (IPL) device for improving signs of dry eye disease due to meibomian gland dysfunction (MGD).
The Lumenis multicenter, 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,” Steven J. Dell, MD, medical director of Dell Laser Consultants and lead investigator in the Lumenis’ clinical trial, said in a company news release.
“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,” Lumenis CEO Tzipi Ozer-Armon said in the news release. “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.
- Farrand et al. Am J Ophthalmol 2017;182:90-98.
- Lemp MA et al. (2012) Cornea May;31(5):472-8.
- FDA study sponsored by Lumenis: internal reference LUM-VBU-M22-IPL-17-01.
- Yan et al. (2020), Eye & Contact Lens 2021, 27(1):45-53.
- Arita et al. (2019) Ocul Surf 17(1):308-13.
- Gao et al. (2019) Int J Ophthalmol 12(11):1708-1713.
- Liu et al. (2017) Am J Ophthalmol 183:81-90.