The United States Food and Drug Administration (FDA) has granted De Novo authorisation for Lumenis’ newest intense pulsed light (IPL) device for improving signs of dry eye disease due to meibomian gland dysfunction (MGD).
Lumenis’ multi-centre, double-blinded, randomised controlled FDA trial showed that Lumenis IPL with patented Optimal Pulse Technology (OPT) significantly improved tear breakup time, meibum quality, and meibomian gland expressibility.1 The clinical trial is one of a number of studies of Lumenis’ IPL with OPT that have shown the same results, as well as reduction of inflammatory markers.2-5
OptLight has been launched in Australia as a “bright solution for dry eyes” subsequent to the FDA approval and Therapeutic Goods Administration listing. OptiLight with Lumenis’ patented OPT technology is designed for a consistent, precise, and controlled light-based treatment of signs of dry eye disease.
Dr Jason Holland, lead clinical optometrist at The Eye Health Centre in Queensland, described Lumenis as “an essential tool” in his practice’s dry eye toolkit.
“In my clinic we deal with dry eye disease every day and have found that in order to make a meaningful impact on the disease, we need to address the underlying inflammation. Lumenis’ OPT technology helps us to address inflammation, as shown in published clinical trials, which improves the signs and symptoms of dry eye disease due to MGD.”
Dry eye disease is a common disorder that causes dry, gritty, burning, tired eyes and fluctuating vision. In January 2020, Optometry Australia reported around 77%6 of Australians have suffered from dry eye symptoms, yet only 26%6 have visited an optometrist to discuss treatment options. Current literature even suggests that up to 86%7 of dry eye patients demonstrate signs of MGD.
- 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.
- Optometry Australia, the 2020 Vision Index Report
- Lemp et al. 2012