Sight Sciences Gets FDA Authorization for PRECISION Trial

Sight Sciences announced 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 seeking clearance for use to perform canal viscodilation alone procedures in adults with POAG.
 
“​I’m excited to begin this prospective study evaluating the safety and efficacy of standalone ab interno canaloplasty using the higher volume OMNI,” said Mark Gallardo, M.D., El Paso Eye Surgeons, principal investigator of the PRECISION clinical trial. “The higher volume (21 microliters versus 11 microliters) of viscoelastic may provide for a greater expansion of Schlemm’s canal and the distal collector system, which in turn may allow for enhanced aqueous outflow with a resultant reduction in pressure. This procedure can become a valuable first-line MIGS procedure for adults with mild to moderate POAG. When more significant pressure and medication reductions are necessary, comprehensively addressing all three points of outflow resistance by coupling canaloplasty with trabeculotomy, may synergistically allow patients to achieve their targeted goals.”
 
“We believe in our technology, including the potential of the higher volume OMNI to address unmet medical needs in POAG patients, and we are excited to develop robust clinical data under this IDE that could support an expanded indication for use for canal viscodilation alone without trabeculotomy,” said Paul Badawi, co-founder and CEO, Sight Sciences. “Compelling, multi-center safety and effectiveness clinical data was necessary for FDA 510(k) clearance of our current combined OMNI indication for use in canaloplasty and trabeculotomy. We are now making the next requisite clinical investments under this IDE to provide the FDA with robust clinical data that could support the safety and effectiveness of a canaloplasty alone indication. We believe that, with the FDA’s authorization to proceed with the PRECISION IDE trial, we will be the first to investigate a MIGS device for use to lower IOP using ab interno transluminal canal viscodilation, or ab interno canaloplasty, alone. This trial is the next step in our path to set the clinical standards of canal viscodilation as a MIGS procedure for POAG. We are very pleased and appreciative of the collaborative IDE process with the FDA and look forward to developing the clinical data necessary to seek clearance for this new specific MIGS indication for the ab interno transluminal viscodilation of Schlemm’s canal, which we believe could meaningfully benefit adult patients with POAG in the future.”