InnFocus’ MicroShunt is the only micro-invasive glaucoma surgery (MIGS) device undergoing a randomized clinical trial that uses trabeculectomy as the comparator.
“We want to get to a point where trabeculectomy is really out of the market,” said Russ Trenary, president and CEO. “The stand-alone market is the place to be.” The glaucoma surgical procedure market is a potential 7 million people in the US alone – but combined procedures only comprise 700,000. With a projected 40% or more CAGR from 2015 to 2020, MIGS represents the largest growth opportunity in ophthalmology, Trenary said, and InnFocus is concentrating on the overall open-angle glaucoma market (representing 59% of the US market, or about 4.15 million patients).
OUS data on almost 100 enrolled patients with pre-op intraocular pressure (IOP) of about 23 mmHg (on full medication) dropped to below 15 mmHg, and that seems to be maintained through 3 years (n = 22).
“These patients are down to a mean of 0.5 medications,” Trenary stated. “More importantly, about 70% are completely off medication.”
Even patients who were on maximum medical therapy but still had baseline IOPs of almost 30 mmHg were able to drop to just under 15 mmHg and maintain those levels through year 2. IOP results are similar regardless of whether cataract removal is part of
the surgical procedure, Trenary said. InnFocus is at the end of its second-phase US study on 400 patients with 1-year follow-up.
Russ Trenary is President & CEO for InnFocus, Inc., an early stage company pioneering a microsurgical solution for glaucoma. He has led, or been a named officer, for medical device companies, for over 20 years.