Sight Sciences reports primary endpoint met in SAHARA trial

Sight Sciences announced the six-month results from the SAHARA randomized controlled trial. The trial successfully met its primary endpoint and the data reported statistically significant improvements as compared to Restasis eye drops for the treatment of dry eye disease. These results will be presented in greater detail at the American Academy of Optometry’s annual meeting in October 2023. SAHARA Phase I Results: The SAHARA trial achieved its primary six-month endpoint, demonstrating the superiority of interventional eyelid procedures enabled by TearCare over Restasis eyedrops in the improvement of tear break up time, a key measure of aqueous retention, tear stability and the tear film’s ability to protect the ocular surface. The SAHARA trial also observed that procedures enabled by TearCare were non-inferior to Restasis eyedrops in Ocular Surface Disease Index, which was the co-primary six-month endpoint. Throughout the study, interventional eyelid procedures with TearCare demonstrated clinically and statistically significant improvements of every endpoint and at every measurement interval: one week, one month, three months, and six months. Endpoints assessed include TBUT, meibomian gland score, corneal staining, and conjunctival staining. Symptoms endpoints include two commonly used patient-reported questionnaires: Ocular Surface Disease Index and Symptom Assessment in Dry Eye. TearCare is intended to help restore healthy function to diseased meibomian glands by removing obstructions interfering with meibum production and outflow. SAHARA is the first of its kind head-to-head, “device versus drug” RCT designed to compare the effectiveness of interventional eyelid procedures enabled by TearCare to twice daily Restasis prescription eyedrops. In this trial, 345 subjects at 25 sites in 14 states were randomized 1:1 between TearCare and Restasis groups. To reduce the potential for bias, physicians evaluating patients were masked regarding subject treatment groups. SAHARA was designed to challenge existing treatment paradigms by focusing physicians’ attention on restorative procedures that address the underlying cause of meibomian gland disease and demonstrate the clinical benefits of procedural dry eye intervention compared to prescription dry eye eyedrops. An abstract of Phase 1 results from SAHARA has been accepted by the American Academy of Optometry for presentation at its annual meeting in October. Sight Sciences plans to submit the findings from SAHARA for publication in peer-reviewed journals in the coming months. In the next phase of the SAHARA study, subjects in the Restasis cohort cease use of Restasis, receive an interventional eyelid procedure with TearCare, and will be monitored for another six months. Subjects in the TearCare cohort will receive additional interventional eyelid procedures as necessary based on pre-determined criteria over an additional 18 months to measure the durability of procedural treatment effect. Final results from SAHARA are expected by 2025.