Ivantis, developer of thel Hydrus Microstent, announced that it has submitted its final premarket approval (PMA) module to the FDA for market approval. The HORIZON pivotal trial is a 556-patient, prospective, randomized trial conducted at 38 centers in 9 countries and on 3 continents. Patients were followed for 2 years. Study subjects with mild-to-moderate primary open angle glaucoma underwent cataract surgery. At the time of surgery, subjects were randomized to receive either cataract surgery alone, or cataract surgery plus the Hydrus Microstent. The HORIZON Study is the largest minimally invasive glaucoma surgery (MIGS) randomized controlled trial completed to date, and the first pivotal trial to span the globe.
"The submission of Ivantis' PMA marks a significant milestone toward our goal of bringing the Hydrus Microstent to market in the United States in 2018, and we look forward to the FDA's review," Dave Van Meter, president and CEO, said in a company news release. "We want to acknowledge the significant effort and contributions from the investigators and clinical sites around the world who participated in the HORIZON Study. The HORIZON Study underscores our commitment to a rigorous, evidence-based approach to evaluating the Hydrus Microstent. On the heels of the prior HYDRUS II Trial, this allows Hydrus to become the first MIGS technology evaluated in two well-controlled trials, conducted in accordance with the ANSI Standard for implantable glaucoma devices, the highest level of evidence defined by the Food and Drug Administration."
"The HORIZON Trial is one of the most rigorous and well conducted trials I have seen, and I wish to congratulate Ivantis and its investigators," Donald Budenz, MD, MPH, and chairman of the Department of Ophthalmology at the University of North Carolina, and a member of the HORIZON Data Safety Monitoring Board (DSMB), said in the news release. "Glaucoma is a rapidly growing global disease, and, as a glaucoma specialist, I applaud the company for pursuing not only the largest randomized, controlled MIGS trial ever run, but one that will teach us about MIGS and its potential for treating glaucoma in the US and across the world. My colleagues and I eagerly await the public presentation and publication of these results, and look forward to the eventual approval of the technology."
Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing the eye's natural outflow pathway, known as Schlemm's canal. Most often, glaucoma patients have both a blockage and a collapse of the canal. The Hydrus Microstent, placed in the canal using a minimally invasive, microsurgical procedure, provides a tri-modal mechanism of action to restore the flow of fluid in the eye. The device opens a bypass through the traditional source of flow blockage, known as the trabecular meshwork; it then dilates and scaffolds Schlemm's canal to enhance outflow, and is the only device to span 90 degrees of the canal to provide consistent access to the eye's fluid collector channels.