Omni receives FDA clearance for additional indication
The FDA has granted 510(k) clearance to the Omni surgical system for canaloplasty followed by trabeculotomy to reduce IOP in primary open-angle glaucoma, according to a press release from Sight Sciences.
“This expanded indication establishes the safety and efficacy of this comprehensive MIGS device in both combination cataract and stand-alone primary open-angle glaucoma patients,” Reay Brown, MD, chief medical officer at Sight Sciences, said in the release.
Omni is also used to deliver viscoelastic fluid during ophthalmic procedures and to cut trabecular meshwork tissue during trabeculotomy. The new indication makes Omni the first cleared ab interno device for stand-alone MIGS procedures in adults with primary open-angle glaucoma, the release said.
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