FDA Clears Sight Sciences' Trial Of Canaloplasty Combined With Cataract Surgery To Lower Ocular Pressure

The FDA has signed off Sight Sciences Inc's SGHT clinical study to assess investigational higher volume OMNI device to perform canal viscodilation alone to lower intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG).
The PRECISION trial is designed as a three-armed randomized controlled trial with patients receiving micro-invasive glaucoma surgery (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 Glaukos Corp's GKOS iStent Inject Canal Implant.
The PRECISION study will evaluate the safety and efficacy of higher volume OMNI for use in canaloplasty without sequential trabeculectomy.
The higher volume OMNI dispenses a higher volume of viscoelastic fluid (21 microliters) higher than the currently marketed OMNI Surgical System (11 microliters).
For Q3, Sight Sciences generated revenue of $13.1 million, +51% Y/Y, and gross margin expanded to 84% from 70% a year ago.
The growth was primarily driven by an increase in the number of facilities ordering OMNI and utilization per ordering facility during Q3.
The Company posted a smaller net loss of $(17.2) million compared to $8.1 million a year ago.
Cash and cash equivalents totaled $271.5 million, and total debt was $32.5 million.
Related content: Benzinga's Full FDA Calendar.
Price Action: SGHT shares are up 1.16% at $24.23 during the premarket session on the last check Thursday.