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Nine FDA actions you might have missed
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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 inject cohort at 24 months. Read more.
FDA clears Alleye AMD monitoring application
Alleye is designed to detect and monitor age-related macular degeneration and characterize central and paracentral metamorphopsia. Read more.
FDA approves moxidectin to treat river blindness
River blindness, caused by the parasitic worm Onchocerca volvulus, is spread by black flies that breed in the rivers of sub-Saharan Africa, Yemen, and South and Central America. Larvae invade skin and eyes, where they can cause permanent blindness, itching and disfiguring skin conditions. Read more.
FDA accepts NDA for loteprednol etabonate ophthalmic gel 0.38%
A new drug application for Bausch + Lomb’s sub-micron loteprednol etabonate ophthalmic gel 0.38% has been accepted by the FDA. Read more.
FDA clears IND application for Oyster Point ’ s dry eye treatment
OC-01, a nicotine acetylcholine receptor agonist, is an investigational compound that stimulates natural tear film production via a nasal spray. Read more.
FDA lifts warning letter against STAAR Surgical
The FDA has issued a close-out letter to STAAR Surgical, lifting a 2014 warning regarding the manufacture of Visian Implantable Collamer Lens devices. Read more.
FDA approves iDESIGN Refractive Studio for LASIK
The iDESIGN, which uses topography-integrated, wavefront-guided technology, allows physicians to take precise measurements of both the inside and outside of the eye to personalize the LASIK procedure to each patient. Read more.
FDA awards RMAT designation to Nightstar ’ s choroideremia treatment
Currently in phase 3 development, NSR-REP1 is comprised of an AAV2 vector containing recombinant human complementary DNA designed to produce the protein REP1 in the eye. Read more.
FDA says Sun Pharma addressed issues at facility in India
Issues observed at Sun Pharma’s Halol facility in Gujarat, India, detailed in an FDA warning letter in December 2015, have been addressed, and the inspection is now closed. Read more.