InnFocus said Wednesday that results from a 3-year trial of its MicroShunt drainage system designed to treat glaucoma patients reported a significant reduction in intraocular pressure and the use of glaucoma medication.
Results from the study were published in the Journal of Glaucoma, the company said.
“These results show not only the potential effectiveness but the possibility for sustainability of low IOP with the InnFocus procedure,” lead author Dr. Juan Batlle said in a press release.
Patients in the study had an average pre-surgical medicated intraocular pressure of 23.8 mm Hg, and after 3-years of treatment with the MicroShunt system reported a 55% reduction in IOP at 10.7 mm Hg. More than 80% of the 22 patients studied had IOPs under 14 mm Hg, and 64% did not require any glaucoma meds after the 3rd year, the Miami, Fla.-based company said.
InnFocus said there were no reports of leaks, infections, migrations, erosions, persistent corneal edema, chronic hypotony or serious long-term adverse events during the trial.
The company is pursuing FDA approval for the device as a minimally invasive stand-alone procedure for mild, moderate and sever open angel glaucoma, and says the final phase of its FDA randomized clinical trial comparing the system to trabeculectomy is “underway.”
In late December, InnFocus said it closed a $33.9 million Series C round for the upcoming clinical trial of its MicroShunt device.
In November, InnFocus won the FDA’s approval to add an additional 412 patients to its clinical trial ahead of a bid for pre-market approval. When the federal safety watchdog agreed to allow the trial expansion, CEO Russ Trenary said InnFocus is “poised to become the clear leader in treating all stages of primary open angle glaucoma.”
The post Innfocus touts 3-year MicroShunt data appeared first on MassDevice.
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