Pivotal Trial Results for Glaukos’ iStent inject® Published in Leading Ophthalmic Journal

Study Published in Ophthalmology Demonstrates Significant, Sustained
Clinical Benefit and Confirms Favorable Safety Profile for
Next-Generation Device Approved by FDA in June 2018

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and
pharmaceutical company focused on the development and commercialization
of novel surgical devices and sustained pharmaceutical therapies
designed to transform the treatment of glaucoma, announced today that
the U.S. Investigational Device Exemption (IDE) pivotal trial results
for its next-generation iStent inject^®
Trabecular Micro-Bypass System have been published in Ophthalmology.

Results of the iStent inject prospective, randomized, controlled,
multicenter clinical trial, which included 505 mild-to-moderate primary
open-angle glaucoma (POAG) subjects from 41 investigational sites,
formed the basis for Food & Drug Administration approval of the device
in June 2018. In the study, 387 subjects were randomized to iStent
inject in combination with cataract surgery and 118 subjects were
randomized to cataract surgery only. Subjects were followed through 24
months with annual medication washouts.

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