FDA approves IPL device to manage dry eye disease

The FDA has granted De Novo authorization to Lumenis Ltd. for its 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

In a multi-center, double-blinded randomly controlled FDA trial, the Lumenis IPL with patented Optimal Pulse Technology(OPT) improved tear breakup time, meibum quality, and meibomian gland expressibility.3 According to the company, this is the latest

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

In the wake of receiving FDA approval, Lumenis is launching OptiLight, a bright solution for dry eyes.

According to the company, OptiLight and the OPT technology can offer a 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.” Steven J. Dell, MD, medical director of Dell Laser Consultants and lead investigator in the Lumenis’ clinical trial submitted to the FDA, said in a statement.

Dell noted that OptiLight allows treating physicians address the inflammation, as shown in Lumenis' IPL clinical trials.

“This improves signs of dry eye disease due to MGD, positioning it as a valuable tool in our dry eye toolkit,” Dell said.

In a statement, Lumenis CEO Tzipi Ozer-Armon said the company is looking forward to continued collaboration with doctors across the US and globally in elevating dry eye care.

The company focuses on minimally-invasive clinical solutions for the surgical, ophthalmology and aesthetic markets, and is developing and commercializing energy-based technologies, including laser, intense pulsed light (IPL) and radio-frequency (RF).

References

1. Farrand et al. Am J Ophthalmol 2017;182:90-98.

2. Lemp MA et al. (2012) Cornea May;31(5):472-8.

3. FDA study sponsored by Lumenis: internal reference LUM-VBU-M22-IPL-17-01.

4. Yan et al. (2020), Eye and Contact Lens 2021, 27(1):45-53.

5. Arita et al. (2019) Ocul Surf 17(1):308-13.

6. Gao et al. (2019) Int J Ophthalmol 12(11):1708-1713.

7. Liu et al. (2017) Am J Ophthalmol 183:81-90.