Venture-backed ophthalmic medical device company Sight Sciences said today it won FDA investigational device exemption approval to initiate a clinical trial of its Visco 360 Viscosurgical System for treating patients with glaucoma.
The multi-center, randomized trial will compare ab interno canaloplasty with the Visco 360 system against selective laster trabeculoplasty. The study will investigate the safety and effectiveness of the Visco 360 system in canaloplasty versus SLT for reducing intraocular pressure in primary open angle glaucoma patients, the company said.
“I have performed hundreds of ab externo canaloplasties over the years with excellent results. I am excited to participate in the Visco 360 study to characterize the safety and effectiveness of ab interno canaloplasty for patients with primary open angle glaucoma who do not need a combined procedure with cataract surgery. I believe that glaucoma specialists, comprehensive ophthalmologists, and any anterior segment surgeons will find this familiar ab interno approach to canaloplasty extremely useful for the care of their mild to moderate glaucoma patients and I look forward to participating in this important pivotal study,” principal investigator Dr. Steven Sarkisian of the University of Oklahoma said in a press release.
The company’s Visco 360 Viscosurgical System is a single-handed, single-use device combining a custom access cannula, flexible microcatheter with an atraumatic tip, internal infusion pump and viscoelsastic reservoir. The system fetures a control wheel designed to retract the microcatheter.
“We are extremely excited to begin this pivotal clinical trial investigating the use of our Visco 360 device for this specific indication. We believe there is a huge unmet need for an effective ab interno glaucoma procedure that is not performed in conjunction with cataract removal and we look forward to working with all of our clinical partners in the execution of this large, robust FDA clinical study,” CEO Paul Badawi said in prepared remarks.
In March, Sight Sciences said it closed an oversubscribed $7 million Series B round of financing.
Sight Sciences produces the Trab 360 and Visco 360 surgical devices as well as a portfolio of technologies in the advanced stages of development for treating evaporative dry eye.
The round was led by Dallas-based private equity firm Hicks Equity Partners, and Sight Sciences said that all Series A investors participated in the B round, including Series A co-lead Scientific Health Development, Allegro Investment Funds and other institutional and angel investors.
The post Second Sight wins IDE for Visco 360 appeared first on MassDevice.
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