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FDA approves iStent inject
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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.