FDA approves microshunt trial for OAG

Miami-InnFocus Inc. has received authorization from the FDA to begin the phase I trial of the InnFocus MicroShunt to treat open-angle glaucoma (OAG).

The trial will be the first to use trabeculectomy with mitomycin C as a study control, according to the company.

“We believe that the excellent clinical results achieved by (this) in earlier clinical evaluations indicate that the device will perform well against the current gold standard of trabeculectomy,” said Leonard Pinchuk, PhD, president of InnFocus.

An ongoing study, now in its third year in the Dominican Republic, shows that the device can lower IOP by 50% to 60% with the average pressure residing between 10 and 12 mm Hg.

“This is particularly important in view of many well-documented studies showing that reducing pressure below 14 mm Hg arrests progression of the disease,” Dr. Pinchuk said.

About 90% of the patients’ pressures are below 14 mm Hg and similar numbers of patients are totally off glaucoma medication, he said.

“The key to our success is our proprietary biomaterial which demonstrates a clinically insignificant foreign body reaction in the eye,” Dr. Pinchuk said

In addition to the FDA authorization, InnFocus has also announced a $13.4 million financing led by HOYA and Saints Capital Everest.

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