Glaucoma company Ivantis disclosed on Monday the receipt of approval from the Food and Drug Administration (FDA) approval for Hydrus Microstent for the treatment of patients with mild to moderate primary open-angle glaucoma, the leading cause of blindness.

According to the company, Hydrus Microstent is a microinvasive glaucoma surgery (MIGS) device that is used to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm's canal, the eye's natural outflow pathway.

The US FDA's approval is based on the company's landmark HORIZON Trial, the largest MIGS study ever conducted. The study included 556 mild to moderate glaucoma patients undergoing cataract surgery, randomized to either receive cataract surgery plus the Hydrus Microstent (treatment) or cataract surgery alone (control).

About 77.2% of patients in the Hydrus Microstent group achieved ≥ 20% reduction in unmedicated intraocular pressure at 24-months postoperative, compared to 57.8% in the cataract surgery alone group, meeting the primary effectiveness endpoint.

To date, this represents the largest improvement over control reported in any MIGS pivotal trial. Additionally, the HORIZON Trial results have been accepted for publication in Ophthalmology, the leading journal in the field (in press, available online 23 June 2018), concluded the company.