Perspective

FDA approves iStent inject

The iStent inject trabecular micro-bypass system has received premarket approval from the FDA for the reduction of IOP, Glaukos announced in a press release.

The approval is based on a pivotal, prospective, randomized, multicenter study of 505 mild to moderate primary open-angle glaucoma patients who were randomly assigned to receive the iStent inject with cataract surgery or cataract surgery only. The trial showed a statistically significant reduction in unmedicated diurnal IOP in the iStent inject cohort at 24 months, the release said.

Designed to optimize the natural outflow of aqueous humor, the iStent inject creates two patent bypasses through the trabecular meshwork for multidirectional flow through Schlemm’s canal.

“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 microscale innovation,” Glaukos President and CEO Thomas Burns said in the release.

U.S. commercial launch activities of the iStent inject are expected to begin in the third quarter, according to the release. The device is already available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa.

The iStent inject trabecular micro-bypass system has received premarket approval from the FDA for the reduction of IOP, Glaukos announced in a press release.

The approval is based on a pivotal, prospective, randomized, multicenter study of 505 mild to moderate primary open-angle glaucoma patients who were randomly assigned to receive the iStent inject with cataract surgery or cataract surgery only. The trial showed a statistically significant reduction in unmedicated diurnal IOP in the iStent inject cohort at 24 months, the release said.

Designed to optimize the natural outflow of aqueous humor, the iStent inject creates two patent bypasses through the trabecular meshwork for multidirectional flow through Schlemm’s canal.

“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 microscale innovation,” Glaukos President and CEO Thomas Burns said in the release.

U.S. commercial launch activities of the iStent inject are expected to begin in the third quarter, according to the release. The device is already available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa.

    Perspective
    John A. Hovanesian

    John A. Hovanesian

    Approval of the iStent inject is a major step forward in the treatment of glaucoma in the U.S. This device makes trabecular bypass as intuitive as it can be and makes MIGS approachable for every cataract surgeon. Those surgeons who have been standing on the sidelines, waiting to get started with MIGS, have a very good reason to begin treating patients now.

    • John A. Hovanesian, MD, FACS
    • OSN Cataract Surgery Section Editor

    Disclosures: Hovanesian reports he is a consultant to Glaukos and several other companies making MIGS devices.