Sight Sciences Announces Completion of Enrollment in SAHARA, a Randomized Clinical Trial of the TearCare® System vs Restasis®

• 310-patient RCT designed to evaluate the superiority of TearCare® (device) vs Restasis® (drug) in patients with chronic dry eye disease is now fully enrolled
• 6-Month efficacy results expected by Summer 2023

Excerpt from the Press Release:

MENLO PARK, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives, today announced the completion of enrollment in the SAHARA Trial, a first of its kind outcomes study designed to evaluate whether an interventional dry eye procedure with the TearCare System is superior in alleviating the signs and symptoms of dry eye disease compared to 6-months of twice daily Restasis® dry eye eyedrops (cyclosporine ophthalmic emulsion, 0.05%). Primary endpoints measured by a masked assessor at 6 months include changes from baseline of Tear Breakup Time (sign) and Ocular Surface Disease Index Score (symptom). Results from the 310-patient, 1:1 randomized SAHARA trial are expected to be available in late Q2 2023.

“While topical prescription therapies play an important role in the treatment of dry eye disease, we believe the interventional TearCare procedure may be a more effective treatment for this chronic disease, based on its fast onset of action, consistent improvements in dry eye signs and symptoms, and durability of treatment effect that we have seen through other TearCare trials and regular clinical use. We are looking forward to comparing the TearCare procedure to daily cyclosporine use in all of these clinically important ways through this RCT,” said Brandon Ayres, M.D., FAAO, Co-Director Cornea Fellowship Program, Wills Eye Hospital. “We look forward to the 6-month results of this landmark “device vs drug” trial for patients suffering from dry eye disease and think it could have major implications in how we think about and treat dry eye disease going forward.”

SAHARA is the first multicenter, randomized controlled trial designed to evaluate whether treatment with a dry eye therapeutic device (TearCare) demonstrates superiority when randomized against a standard of care dry eye prescription topical medication (Restasis®).

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