In calendar 2016, the US FDA approved ~105 new drugs (New Drug Applications and Biologic Licensing Approvals). Of these, ~22 were for “New Medical Entities”. Of the 105, 8 were for ophthalmic products. Among these were 4 different approvals for Avedro’s Photrexa® in various forms for various corneal indications. The others were: tetracaine for local anesthesia, bromfenac in Durasite™ for post-operative inflammation (BromSite™), lifitegrast for dry eye (Xiidra®), and multi-dose non-preserved cyclosporine (Restasis®). Also of note was the additional indication for adalimumab (Humira®) for posterior uveitis.
In calendar 2016, FDA’s Center for Devices approved three new PMAs in ophthalmology (Visumax™ Femtosecond Laser, the Cypass™ Micro-Stent, and the Raindrop™ Near Vision Inlay), and cleared one new 510K in ophthalmology (Xen® for glaucoma).