MAY 06, 2015
Transcend Medical, Inc.
Cataract/Anterior Segment, Glaucoma
Transcend Medical announced that the CyPass microstent used in combination with cataract surgery can achieve sustained IOP reduction in glaucoma patients for up to 2 years.
The company plans to file a Premarket Approval application with the FDA during the second half of this year. The device has already received the CE Mark in Europe.
The CyPass is the first stent designed to reduce IOP by enhancing aqueous outflow to the suprachoroidal space. It avoids the trabecular meshwork and Schlemm’s canal—a drainage pathway that is believed to be compromised in glaucomatous eyes.
The COMPASS study included more than 500 patients with mild to moderate glaucoma randomized to undergo cataract surgery in combination with the CyPass or cataract surgery alone. All patients were medication-free at baseline and at the 1- and 2-year follow-up visits, but a significantly higher proportion in the combined surgery group experienced a 20% or greater reduction in IOP from baseline at one and two years compared with patients randomized to cataract surgery alone.“With an elegant, straightforward implantation procedure coupled with these positive clinical outcomes, the CyPass Microstent is positioned to provide a valuable new therapeutic option for ophthalmologists treating their cataract patients suffering from glaucoma.” said Dr. Steven Vold, MD, president of Vold Vision in Fayetteville, Ark., chair of the COMPASS Steering Committee, and one of the lead investigators for the study.