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.
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Posted-In: Briefs glaucomaNews Health Care Small Cap FDA General
