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Sight Sciences Announces FDA Authorization for the PRECISION Trial, a Groundbreaking Three-Arm Randomized, Controlled IDE Trial of Canal Viscodilation in Combination with Cataract Surgery in Adults with Primary Open-Angle Glaucoma (POAG)
As the pioneer of ab interno canaloplasty, Sight Sciences is executing this IDE trial to seek FDA clearance for canal viscodilation alone as a MIGS procedure
About this update from Sight Sciences, Inc.
[{"type":"text","content":"As the pioneer of ab interno canaloplasty, Sight Sciences is executing this IDE trial to seek FDA clearance for canal viscodilation alone as a MIGS procedure for adults with POAG\nMENLO PARK, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced that the Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) authorizing the Company to conduct a clinical study to assess the safety and effectiveness of a new, higher volume (21 microliters of viscoelastic fluid dispensed), investigational OMNI® device (“higher volume OMNI”) to perform canal viscodilation alone to lower intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG). The PRECISION clinical trial is designed as a three-armed randomized controlled trial (RCT), which the Company believes will be the first of its kind and represents the largest MIGS clinical trial ever initiated, based on total number of patients receiving MIGS interventions in conjunction with cataract surgery (n=459). The devices that will be evaluated in the study are the higher volume OMNI (Sight Sciences) and the iStent Inject Canal Implant (Glaukos). In the three arms of the study, patients will receive one of the following treatments in conjunction with cataract surgery: (1) ab interno canaloplasty alone using higher volume OMNI; (2) sequential canaloplasty followed by trabeculotomy using higher volume OMNI; or (3) implantation of two trabecular microbypass canal implants using iStent Inject. The PRECISION study is intended to evaluate for regulatory purposes the safety and efficacy of higher volume OMNI for use in canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) without sequential trabeculotomy (cutting of trabecular meshwork (TM)) for IOP and medication reduction in adult patients with POAG. The higher volume OMNI is a next-generation OMNI device that dispenses a higher volume of viscoelastic fluid (21 microliters) than the currently marketed OMNI Surgical System (11 microliters). Sight Sciences is conducting this canal viscodilation alone IDE trial, which is believed to be necessary to support a premarket notification to the FDA seek...