Glaukos (NYSE:GKOS) said today it won FDA premarket approval for its iStent inject trabecular micro-bypass system.
With the clearance, the iStent inject is now indicated for use in the reduction of intraocular pressure in adults with mild to moderate primary open-angle glaucoma who are undergoing concomitant cataract surgery.
San Clemente, Calif.-based Glaukos said the iStent inject is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It uses a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecular meshwork locations via a single corneal entry point.
Glaukos said that it believes the iStent inject is the smallest medical device ever to win clearance from the FDA.
“The approval of iStent inject represents another major Glaukos milestone in the pursuit of our mission to transform glaucoma therapy and further strengthens our position at the forefront of micro-scale innovation. We greatly appreciate the diligent work of the FDA to conduct a thorough and timely review of the iStent inject and grant approval. In addition, we are very grateful to the investigators and patients who participated in the clinical trial and played an instrumental role in helping us to bring iStent inject to the U.S. Given its clinical performance and enhanced procedural elegance, we believe the iStent inject will be an attractive, two-stent solution for U.S. ophthalmic surgeons to reliably manage glaucoma patients’ IOP in a straightforward and effective manner,” prez & CEO Thomas Burns said in a press release.
Approval came backed by data from a 505-patient trial randomized to either treatment with iStent inject plus cataract surgery, or cataract surgery alone. Data from the study indicated that use of the iStent inject resulted in a 20% or greater reduction in unmedicated diurnal IOP in patients undergoing cataract surgery at 24 months.
At two years, 75.3% of the cohort who received the iStent inject achieved a 20% or greater reduction in unmedicated intraocular pressure compared to 61.9% in the cataract-surgery-only cohort. Mean unmedicated IOP amongst iStent patients was 6.9 mmHg compared to 5.4 mmHg for the cataract-only cohort.
Results indicated that at two years, the iStent inject cohort had a 31% mean reduction in unmedicated IOP of 17.11 mmHg from a baseline of 24.8 mmHG and that 62.6% of the cohort achieved an unmedicated mean IOP at or below 18 mmHg, compared to only 49.2% in the cataract-surgery-only cohort.
Glaukos said that following the completion of “various administrative matters with the FDA,” it plans to begin commercialization in the third quarter.
“U.S. ophthalmic surgeons have been eagerly awaiting the availability of iStent inject, which offers them an exciting new treatment option for effectively managing glaucoma patients’ IOP while potentially reducing or eliminating the need for topical hypotensive medications. The results of the U.S. trial, along with those of numerous international peer-reviewed studies, confirm that iStent inject provides predictable, clinically significant IOP reductions with an excellent safety profile through an elegant, micro-invasive procedure with minimal tissue disruption,” iStent inject pivotal trial investigator Dr. Thomas Samuelson of the University of Minnesota said in a prepared statement.
Last month, Glaukos saw shares fall after the ophthalmic medical tech company posted first quarter earnings that saw profits swing to losses, despite topping The Street’s expectations.
