The FDA has cleared Sight Sciences Inc's (NASDAQ:SGHT) TearCare System for meibomian gland dysfunction (MGD), the leading cause of dry eye disease (DED).
- The indication clears TearCare for applying localized heat therapy in adult patients with evaporative DED due to MGD when used with the manual expression of the meibomian glands.
- The TearCare System provides safe and effective localized heat therapy intended to help soften or liquify thickened meibum for effective gland clearance.
- Related content: Benzinga's Full FDA Calendar.
- The FDA clearance is based on data from multiple studies of the TearCare System, including recent safety and effectiveness clinical data from the pivotal OLYMPIA study published in Cornea.
- At one month post-treatment in the OLYMPIA study, patients who received a single TearCare procedure showed significant improvements (P<0.0001) in mean tear film breakup time and meibomian gland secretion score.
- TearCare subjects also showed significant reductions in mean eye dryness, Symptom Assessment in Dry Eye (SANDE), and Ocular Surface Disease Index scores.
- In the study, 72% of TearCare patients showed OSDI improvement by at least one severity category, and 81% of TearCare patients met Miller's definition of clinically meaningful improvement in OSDI.
- Price Action: SGHT shares are down 0.64% at $18.65 during the market session on the last check Wednesday.
