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
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