- 310-patient RCT designed to judge the prevalence of TearCare® (system) vs Restasis® (drug) in sufferers with continual dry eye illness is now absolutely enrolled
- 6-Month efficacy outcomes anticipated by Summer 2023
MENLO PARK, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare know-how firm centered on creating revolutionary options meant to rework care and enhance sufferers’ lives, in the present day introduced the completion of enrollment in the SAHARA Trial, a primary of its variety outcomes examine designed to judge whether or not an interventional dry eye process with the TearCare System is superior in assuaging the indicators and signs of dry eye illness in comparison with 6-months of twice each day Restasis® dry eye eyedrops (cyclosporine ophthalmic emulsion, 0.05%). Primary endpoints measured by a masked assessor at 6 months embody adjustments from baseline of Tear Breakup Time (signal) and Ocular Surface Disease Index Score (symptom). Results from the 310-patient, 1:1 randomized SAHARA trial are anticipated to be out there 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,” mentioned 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 sufferers affected by dry eye illness and suppose it may have main implications in how we take into consideration and deal with dry eye illness going ahead.”
SAHARA is the primary multicenter, randomized managed trial designed to judge whether or not remedy with a dry eye therapeutic system (TearCare) demonstrates superiority when randomized in opposition to an ordinary of care dry eye prescription topical medicine (Restasis®). Patients in the TearCare group underwent an in-office eyelid debridement, 15-minute bilateral, precision managed thermal session with TearCare, instantly adopted by doctor guided guide expression of the meibomian glands. Patients in the Restasis® management group self-administered 1 drop of Restasis twice a day on daily basis for six months with medical assessments accomplished on the 6-month timepoint. The major superiority endpoint measures to be evaluated at six-months, a interval that gives enough time for the whole onset of cyclosporine’s mechanism of motion, are imply change from baseline in tear breakup time (TBUT) and ocular floor illness index (OSDI) scores. SAHARA’s two major endpoint end result measurements of TBUT (signal) and OSDI (symptom) are established methods in which clinicians assess dry eye illness. Following the 6-month read-out, all Restasis sufferers shall be crossed over to the TearCare group and obtain a TearCare process. All 310 sufferers shall be adopted for a further 18 months to evaluate sturdiness of TearCare remedy and re-treatment impact over a complete medical trial interval of two years.
“We’d like to thank our clinical investigators, their site staffs, and all study subjects for their participation in our pivotal “drug vs device” dry eye trial,” mentioned Paul Badawi, Co-Founder and CEO of Sight Sciences. “We embarked on SAHARA, the largest randomized controlled trial with the longest follow-up analysis of any dry eye disease RCT, with patients and payors in mind. We’ve remained steadfast in our commitment to delivering best-in-category clinical outcomes and seeking comprehensive coverage and reimbursed access to TearCare for patients whose eye care practitioners believe it is a medically necessary and reasonable treatment option to address their MGD. Having consulted from the very beginning with national and regional payors to get their input on the type of trial design that would support coverage and payment for TearCare, we arrived at SAHARA. We look forward to the important results of this pivotal “drug vs device” RCT for sufferers affected by continual dry eye illness.”
Additional info on the SAHARA trial may be discovered at www.clinicaltrials.gov.
About Sight Sciences
Sight Sciences is an eyecare know-how firm centered on creating and commercializing revolutionary options meant to rework care and enhance sufferers’ lives. Using minimally invasive or non-invasive approaches to focus on the underlying causes of the world’s most prevalent eye illnesses, Sight Sciences seeks to create simpler remedy paradigms that improve affected person care and supplant typical outdated approaches. The Company’s OMNI® Surgical System is a minimally invasive glaucoma surgical procedure (MIGS) system indicated to cut back intraocular strain in grownup sufferers with major open-angle glaucoma (POAG), the world’s main trigger of irreversible blindness. The Company’s TearCare® System is 510(okay) cleared for the applying of localized warmth remedy in grownup sufferers with evaporative dry eye illness attributable to meibomian gland dysfunction (MGD), enabling office-based clearance of gland obstructions by a watch care skilled to handle the main trigger of dry eye illness. For extra info, go to www.sightsciences.com.
About the TearCare® System
The TearCare System is FDA cleared and indicated for the software of localized warmth remedy in grownup sufferers with evaporative dry eye illness attributable to meibomian gland dysfunction, when used in conjunction with guide expression of the meibomian glands.
The TearCare System is the one system designed to evacuate obstructed meibomian glands whereas harnessing a pure blink expertise. The system is comprised of single-use, universally becoming SmartLids™ that are positioned on the eyelids to soundly and successfully ship “intelligent therapeutic heat”. The transportable SmartHub™ communicates instantly with the SmartLids to exactly management the quantity of section transition heating and the period of remedy. After quarter-hour of therapeutic warmth, the Clearance Assistant forceps permits the ECP to regulate expression of the stagnant, obstructed meibum expertly and exactly by focusing on particular person meibomian glands whereas acquiring full visible affirmation of the success of this customized remedy.
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Gilmartin Group
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