Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye
AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease. In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001)
Clinical Trial Information about COMET-4, found here.
AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available.
Clinical Trials
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (Kauai)
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (STRIDE 1)
Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (STRIDE 2)
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (STRIDE 3)
EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25%
EYSUVIS® is the first and only FDA-approved corticosteroid for short-term dry eye treatment.
IMPORTANT SAFETY INFORMATION
EYSUVIS® should not be used if you have a viral infection in your eye. Talk to your doctor before using EYSUVIS® if you think you may have a viral, bacterial, or fungal eye infection.
Your doctor should examine your eyes before prescribing EYSUVIS®, to check for increased eye pressure or damage to the surface of the eye.
Consult your doctor if pain, redness, itching, or inflammation develops or gets worse. Wash your hands well before each use.
Do not allow the dropper tip to touch any surface, as this may contaminate the suspension. Shake the bottle for two to three seconds before using. If a dose is missed, take the missed dose when remembered.
Remove contact lenses before using EYSUVIS®; they may be reinserted 15 minutes later. The most common adverse drug reaction following the use of EYSUVIS® for two weeks was instillation site pain, which was reported in 5% of patients.