Benzinga | Nov 11, 2021 07:25AM EST

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

* The FDA has signed off Sight Sciences Inc's (NASDAQ: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 (NYSE: 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.