Sight Sciences, Inc. announced the six-month results from the SAHARA randomized controlled trial (RCT).
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 (TBUT), 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 (OSDI), 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 (OSDI) and Symptom Assessment in Dry Eye (SANDE).
“At each measurement interval over the initial six-month study period, subjects in the TearCare cohort exhibited statistically significant improvement in all key signs and symptoms,” remarked Brandon Ayres, MD, FAAO, Co-Director Cornea Fellowship Program, Wills Eye Hospital and a Principal Investigator of Sahara. “As we hypothesized, the data from the SAHARA trial suggests that interventional eyelid procedures enabled by TearCare technology help directly address the root cause of MGD and were more effective than topical Restasis eyedrops in treating dry eye on an aggregate basis across the endpoints measured in the SAHARA trial. TearCare patients in the SAHARA trial benefitted from improved function of obstructed and diseased meibomian glands and experienced rapid improvement in dry eye symptoms. The results from SAHARA support and build on the results from prior TearCare technology trials. This landmark “device vs. drug” trial shows we should change how we treat meibomian gland disease and dry eye in the future.”
“We are extremely pleased with the successful 6-month results of the SAHARA RCT. The data from this trial support our belief in the clinical superiority of interventional eyelid procedures enabled by TearCare technology versus Restasis,” said Paul Badawi, co-founder and CEO of Sight Sciences. “We focus on developing interventional technologies and procedures that can comprehensively address the underlying causes of eye disease and this is evident in both our OMNI technology for primary open angle glaucoma as well as our TearCare technology for meibomian gland disease. SAHARA demonstrates the rigor we embrace in designing clinical trials to establish the clinical value of our products and procedures.”
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 (cyclosporine ophthalmic emulsion, 0.05%).
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 (MGD) and demonstrate the clinical benefits of procedural dry eye intervention compared to prescription dry eye eyedrops.
Over 17 million Americans are diagnosed with dry eye disease and studies have shown that MGD is associated with up to 86% of dry eye disease³. Currently, over the counter and prescription eyedrops are the dominant treatment for dry eye with costs to payors and patients exceeding $2 billion annually.⁴
Eyedrops do not address obstructed meibomian glands, the root underlying cause of MGD. Sight Sciences designed its TearCare technology and its comprehensive interventional eyelid procedure to safely and effectively treat the underlying obstructive causes of MGD.
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 (24 months total study period) to measure the durability of procedural treatment effect. Final results from SAHARA are expected by 2025.