Published in Pipeline

Sight Sciences announces results of 3-year GEMINI trial and SAHARA RCT at ASCRS annual meeting

Sight Sciences, Inc. announced that data from studies of two of its proprietary glaucoma and dry eye technologies, the OMNI Surgical System (“OMNI”) and the TearCare System (“TearCare”), will be presented in two oral presentations and two posters at this year’s ASCRS Annual meeting April 5 to 8 in Boston, MA.

OMNI technology facilitates surgeons’ ability to perform a comprehensive, implant-free, minimally invasive glaucoma surgical procedure in adults with primary open-angle glaucoma (“POAG”). TearCare technology enables a proprietary, interventional eyelid procedure for diseased meibomian glands and is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease (“DED”) due to meibomian gland dysfunction, when used in conjunction with manual expression of the meibomian glands.

“We are excited that additional data supporting the efficacy and safety of our OMNI and TearCare technologies will be presented at ASCRS, the largest annual gathering for anterior segment surgeons,” said Paul Badawi, CEO and co-founder of Sight Sciences. “In addition to our existing robust body of clinical evidence, we now have additional data showing impressive OMNI results at 36-months, which demonstrate the vital long-term element of OMNI’s efficacy. We are also pleased that new TearCare data will be shared that supports the use of TearCare technology as a primary treatment for DED.”

Oral Presentation: OMNI Surgical System

  • 36-Month Outcomes for Canaloplasty and Trabeculotomy Combined with Cataract Surgery: Extended Follow-up from the Gemini Study – oral presentation on Sunday, April 7, at 3:50 PM ET at the BCEC Meeting level 2 room 259A. Lead author: Arkadiy Yadgarov, MD

“Long-term data is key in the selection of a surgical treatment,” said Arkadiy Yadgarov, MD, of Omni Eye Services of Atlanta, GA. “The 12-month GEMINI trial demonstrated efficacy of the OMNI procedure combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma.1,2 This extension of the trial shows that these positive 12-month outcomes were sustained through 36 months.”

Oral and Paper Presentations: TearCare System

  • Tear Break-up, Meibomian Gland, and Dry Eye Symptom Improvement for Cyclosporine-Treated Patients after Localized Heat Therapy Treatment (SAHARA Cross-Over/phase 2) – oral presentation on Sunday, April 7 at 3:30 PM ET at the BCEC Meeting level 2, room 259B. Lead author: Brandon Ayres, MD
  • Rapid Improvement in the Signs and Symptoms of Dry Eye Disease with Localized Heat Therapy (LHT) or Cyclosporine Ophthalmic Emulsion (CsA) (SAHARA subanalysis) – poster presentation. Lead author: Julio Echegoyen, MD, PhD
  • Localized Heat Therapy (LHT) Compared to Cyclosporine Ophthalmic Emulsion (CsA): A Subanalysis on Age, Gender, and Disease Burden (SAHARA subanalysis) – poster presentation. Lead author: Jennifer Loh, MD

“These data once again support the conclusion that TearCare should be a preferred treatment for DED associated with meibomian gland dysfunction,” says Brandon Ayres, MD, of Wills Eye Hospital, Philadelphia, PA. “In phase 1 of the SAHARA trial, we found the interventional TearCare procedure provided statistically superior and sustained improvement in tear break-up time and multiple measures of meibomian gland secretion when compared to treatment with Restasis.3 In phase 2 (cross-over) of the study, we found that a single TearCare procedure improved signs and symptoms for patients beyond what was achieved with six months of Restasis.”


Red Carpet Event
Additionally, at ASCRS, Sight Sciences will be hosting a red carpet event at its booth (#545), where the company will celebrate its shared commitment to elevating eyecare for the benefit of patients. The event will be on Saturday, April 6, 2024, from 3:45 PM to 4:30 PM ET. Learn more about this and other Sight Sciences activities at ASCRS at www.sightsciences.com/ascrs


References
1. GALLARDO MJ, PYFER MF, VOLD SD, ET AL. CANALOPLASTY AND TRABECULOTOMY COMBINED WITH PHACOEMULSIFICATION FOR GLAUCOMA: 12-MONTH RESULTS OF THE GEMINI STUDY. CLIN OPHTHALMOL. 2022;16:1225-1234. PUBLISHED 2022 APR 21. DOI:10.2147/OPTH.S362932
2. GREENWOOD MD, YADGAROV A, FLOWERS BE, ET AL. 36-MONTH OUTCOMES FROM THE PROSPECTIVE GEMINI STUDY: CANALOPLASTY AND TRABECULOTOMY COMBINED WITH CATARACT SURGERY FOR PATIENTS WITH PRIMARY OPEN-ANGLE GLAUCOMA. CLIN OPHTHALMOL. 2023;17:3817-3824. PUBLISHED 2023 DEC 12. DOI:10.2147/OPTH.S446486
3. AYRES BD, BLOOMENSTEIN MR, LOH J, ET AL. A RANDOMIZED, CONTROLLED TRIAL COMPARING TEARCARE® AND CYCLOSPORINE OPHTHALMIC EMULSION FOR THE TREATMENT OF DRY EYE DISEASE (SAHARA). CLIN OPHTHALMOL. 2023;17:3925-3940. PUBLISHED 2023 DEC 18. DOI:10.2147/OPTH.S442971