Ivantis Now Has Its MIGS Stent Approved

The competition in the microinvasive glaucoma surgical (MIGS) space is certainly heating up after today’s news. FDA has given a nod to Ivantis’ Hydrus Microstent, which will undoubtedly compete against Glaukos’ iStent. Irvine,CA-based Ivantis’ approval comes on the heels of Glaukos winning a nod from FDA for the iStent inject Trabecular Micro-Bypass System. The Hydrus Microstent is used to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. The device’s approval is based on the HORIZON Trial, a study that included 556 patients either receiving cataract surgery plus the Hydrus Microstent or cataract surgery alone. Data from the study showed that about 77.2% of patients in the Hydrus Microstent group achieved a statistically significant decrease at 24-months postoperative compared to 57.8% in the cataract surgery alone group. Ivantis said the secondary effectiveness endpoint was also met, with Hydrus Microstent patients achieving a mean intraocular pressure (IOP) reduction of 7.5 mmHg, a difference of 2.3 mmHg compared to cataract surgery alone. Several epidemiological studies have shown that each point of IOP reduction reduces the risk of progression of glaucoma. Ivantis said the 43% improvement for the treatment group over control is also the largest of any MIGS pivotal trial to date. Ivantis said the HORIZON Trial results have been acce...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news