FDA Approves Sight Sciences' TearCare System For Common Eye Condition

The FDA has cleared Sight Sciences Inc's 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.
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