The year 2015 represented a milestone for Transcend Medical – it completed a milestone study and filed a Premarket Approval for a minimally invasive glaucoma surgery (MIGS) device, the CyPass Micro-Stent.
The CyPass is a next-generation device designed to enhance aqueous outflow to the suprachoroidal space by being placed in the supraciliary space (an ab interno location) through a 1.5-mm clear corneal incision.
Both cataract and glaucoma surgeons can perform the gonio-free procedure; because the device sits in the supraciliary space, the need to visualize the trabecular meshwork is eliminated. According to the company, several recent studies have validated the therapeutic potential of the suprachoroidal space. Other groups have shown a single injection into the suprachoroidal space grants access to the entire space, which Transcend has confirmed in both preclinical and clinical studies. Evidence exists that there is almost a 4-mm Hg gradient that drives the aqueous from the anterior chamber to the suprachoroidal space without the need to create an opening in the sclera or elsewhere. With more than 3,000 successful cases worldwide, Transcend Medical has completed the largest MIGS trial to date. Throughout the 10 years’ of study on the device, there has been a “very consistent, sustained intraocular pressure lowering,” of 30% to 35% out to three years, said Chief Medical Officer Sean Ianchulev, MD, MPH, who believes the device will be commercially successful as both a stand-alone and in combination with cataract surgery. The firm is only pursuing a combination approach (CyPass Micro-Stent and phacoemulsification) in the US., but has a CE mark for both combination and stand-alone procedures in the European Union. To date, no major vision threatening complications have been reported.
The company expects to share data from the COMPASS trial in early 2016; that study has enrolled 505 patients with a two-year follow-up to evaluate both safety and efficacy.
Transcend has developed the CyPass VX, which allows a viscosurgical device (OVD) to be injected behind the stem to expand the suprachoroidal space by a factor of 50; this creates an internal reservoir, which is able to provide more absorption of the aqueous and better intraocular pressure (IOP) lowering. If future studies prove successful, this may be a means of addressing neovascular glaucoma. Early randomized studies on the device indicate the CyPass VX provides “incremental benefits” when 30 to 60 mL of OVD is injected.
Sean Ianchulev, MD, MPH
Dr. Ianchulev is a physician-executive, innovator and venture capital investor with deep life-science and medical technology expertise.