The FDA has issued approvals and clearances and closed out warning letters in recent weeks regarding multiple companies and products in the ophthalmology industry.
Here are nine recent FDA actions as reported on Healio.com/OSN:
FDA approves iStent inject
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
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