FDA clears TearCare system for treatment of meibomian gland dysfunction
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The TearCare system has received 510(k) clearance from the FDA for the treatment of meibomian gland dysfunction, according to a press release from Sight Sciences.
The system works by providing localized heat therapy to soften or liquefy thickened meibum inside the glands to allow for more effective gland clearance.
The clearance is based on data from several studies, including OLYMPIA. Patients who underwent a single TearCare procedure had statistically significant improvements in mean tear film breakup time and meibomian gland secretion score at 1 month after treatment.
“While historic treatments for dry eye, such as artificial tears and prescription eye drops, help address symptoms of dry eye and other potential causes, treatments for MGD remain an essential therapy for our dry eye patients,” Preeya K. Gupta, MD, lead author of the OLYMPIA study, said in the release. “The OLYMPIA study further validates the safety and efficacy of the TearCare system to treat MGD, and we are excited to offer our patients an FDA-cleared option that can help clinicians clear gland obstructions and deliver better outcomes for adult MGD patients.”
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