The U.S. Food and Drug Administration granted 510(k) clearance of the TearCare System (Sight Sciences, Inc) for the treatment of meibomian gland dysfunction (MGD), the leading cause of dry eye disease (DED), according to a company press release.
The indication clears TearCare for the application of localized heat therapy in adult patients with evaporative DED due to MGD, when used in conjunction with manual expression of the meibomian glands.
Clearance is based on data from multiple studies, including the OLYMPIA in which patients treated with one TearCare procedure showed significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score. Patients treated with TearCare also showed significant reductions in mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores (P < 0.0001). Ocular Surface Disease Index scores improved by ≥1 severity category in 72% of patients treated with TearCare in the OLYMPIA study and 81% of patients treated with TearCare met Miller’s definition of clinically meaningful improvement in Ocular Surface Disease Index.
“With such a significant number of DED cases caused by MGD, clinicians need a safe and effective modality to treat underlying meibomian gland obstruction in these patients,” said Preeya K. Gupta, MD, Managing Director of Triangle Eye Consultants and lead author of the OLYMPIA study, in the press release. “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. 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.”
Read the full press release here.
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