SAN FRANCISCO — Thanks to a pending boom in minimally invasive glaucoma surgery (MIGS) devices, the global glaucoma device market is poised to come out of its long slumber and triple over the next five years, participants at the fifth annual “Glaucoma 360-New Horizons Forum” heard.
Sponsored by the non-profit Glaucoma Research Foundation, the forum aims to bring together the various players involved in advancing the new ideas and innovations in glaucoma into clinical use.
For many years, the $5 billion global glaucoma market was notably sleepy, with minimal innovation on both the pharmaceutical and device side. No significant new classes of pharmaceutical agents have been approved since the first prostaglandin (latanoprost) gained clearance in 1996. The device side has languished with older laser technologies (trabeculoplasty) and relatively inef-fective and/or risky surgical procedures (trabeculectomy and shunts) being the mainstays in treating drug-resistant or non-compliant patients.
The device/surgical landscape changed dramatically in June 2012 with FDA approval of the Glaukos iStent. Revenue from iStent in 2015, in just its second full year of commercialization, exceeded $71 million, a 57% increase over 2014, Glaukos reported.
The iStent represents the first in a wave of new MIGS devices queued for approval. On the near horizon is AqueSys, which Allergan acquired in October 2015 for $300 million plus potential future earn-out payments. Before the acquisition, AqueSys management had said publicly that they expected to garner a 510(k) FDA clearance for the XEN Gel Stent this year.
In May this year, the COMPASS pivotal trial data for the CyPass Micro-Stent from Transcend Medical will likely be released at the annual meeting of the American Society of Cataract and Refractive Surgery. Industry sources believe that Transcend will likely be invited to an FDA Oph-thalmic Advisory Panel meeting in either late 2Q or 3Q 2016.
Presenting at Glaucoma 360, Dr. Steven Vold said “MIGS is transforming the way we treat combined cataract and glaucoma.” He spoke highly of the CyPass Micro-Stent, saying that it provides “novel [non-trabecular] aqueous outflow enhancement using supraciliary versus trabecular stenting.”
Other contenders in the MIGS space are Ivantis and InnFocus, which expect to get FDA approval over the next few years. The former completed enrollment in April 2015 for the HYDRUS IV clinical trial, which enrolled 556 patients, the largest MIGS study ever. Ivantis is currently in the FDA mandated two-year follow-up period and could reach the domestic market in 2018.
InnFocus, which also presented at Glaucoma 360, is rapidly enrolling for its 412 patient pivotal trial, which it expects to complete in the next 12 to 18 months. It will compare the MicroShunt with trabeculectomy. Importantly, the FDA also recently informed the company that it will require only a one-year follow-up to the pivotal trial data, shortening the path to US commercialization. Specifically, the firm’s device could be approved sometime in 2018 or 1Q 2019.
As a positive effect of these MIGS devices moving toward commercialization, the market research firm Market Scope is forecasting that the global glaucoma device market will soar from $354 million in 2015 to $1.1 billion in 2020 – a hefty compound annual growth rate of 26%.
MIGS has given the glaucoma market its wake-up call.