The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 46 new medical entities in 2017. This was a record high for the last ten years. PharmaLogic supported at least two of them, one of them considered to be a first in class.
With recent press releases by the Sponsors, there are at least five ophthalmic New Drug Applications (NDAs) under review by the U.S. FDA at this time (25 April 2017). Some of these were held up for chemistry issues in their original 2016 submissions.
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).
Dr. Novack’s presentations in 2014 include: FDA requirements for new drugs at Glaucoma 360 (Glaucoma Research Foundation), “Better Therapeutics in Glaucoma Through Drug Delivery” in the Innovator’s symposium at the American Society for Cataract & Refractive Surgery, and a Phase 2b study of AR-13324 in glaucoma and ocular hypertension at ARVO.
Dr. Novack continues to advise numerous companies on FDA interactions, including critical End of Phase 2 meetings, with frequent meetings with the FDA. Numerous investment firms have asked Dr. Novack’s advise on investments in innovative ophthalmic firms.
Dr. Novack has worked with advised numerous companies their FDA and EMA interactions on new drugs, including accompanying clients to their regulatory meetings.
In June 2013, Dr. Novack was officially thanked for his 16 years of service to the UC Santa Cruz Foundation, including serving as past president.
The year 2012 has been a great one for approvals for PharmaLogic. Four products on which we made substantial contributions were approved in the U.S. : iStent® Trabecular Micro-Bypass Stent, Jetrea® (ocriplasmin), Kyprolis® (carfilzomib), and Myrbetriq® (mirabegron).