OptiLight is an IPL device indicated for patients aged 22 years and above with symptoms of DED due to MGD and with Fitzpatrick skin types I-IV
Lumenis has received the FDA De Novo authorisation for its new intense pulsed light (IPL) device, dubbed OptiLight, to improve signs of dry eye disease (DED) due to meibomian gland dysfunction (MGD).
OptiLight is an IPL device with a spectrum of 400-1200nm, indicated for patients aged 22 years and above with symptoms of DED due to MGD and with Fitzpatrick skin types I-IV.
IPL is designed only for external application to skin on the malar region of the face, from tragus to tragus including the nose, with eyes fully covered by protective eyewear.
The treatment is intended as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.
Lumenis CEO Tzipi Ozer-Armon said: “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.
“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.”
The FDA approval is based on a multi-centre, double-blinded, randomised controlled trial that showed Lumenis IPL with patented Optimal Pulse Technology (OPT) improved tear breakup time, meibum quality and meibomian gland expressibility.
The Israeli medical device company said that the clinical trial joins a series of studies of IPL with OPT technology that demonstrated similar results, along with reduction of inflammatory markers.
OptiLight with Lumenis’ patented OPT technology is designed for a consistent, precise, and controlled light-based treatment of signs of dry eye disease, said the company.
Dry eye disease is a common disorder that causes dry, gritty, burning, tired eyes and fluctuating vision, and MGD is a major cause of dry eye disease.
Lumenis clinical trial lead investigator Steven Dell said: “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.”