Ophthalmology Therapeutic Roundup — January 26, 2017

Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week. 

• According to various media reports, Novartis AG is considering alternatives for its Alcon division, including a spinoff or an initial public offering.
• IACTA Pharmaceuticals, Inc. has acquired the North American rights to develop and commercialize NM133 — an investigational medicine designed to help treat dry eye -- from its developer, Nanomerics, Ltd.
• Nicox S.A. recently provided a clinical and regulatory update for NCX 470 -- a nitric oxide (NO) donating bimatoprost analog being developed for intraocular pressure (IOP) lowering. The company reported it had completed a positive pre-Investigational New Drug (IND) with the U.S. FDA, and expects to file its IND in the fourth quarter of 2017, with a first-in-human Phase 2 clinical study expected to start in the first quarter of 2018. 
• Ocular Therapeutix, Inc. has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Dextenza™ (dexamethasone insert) 0.4 mg, for the treatment of ocular pain occurring after ophthalmic surgery. The company reportedly believes the FDA review period of the NDA resubmission could take between two to six months.
• Eyegate Pharmaceuticals, Inc. has been granted a Canadian patent that covers an aqueous dexamethasone formulation comprising dexamethasone phosphate and the use of the formulation for delivering dexamethasone phosphate to ocular tissue via iontophoresis. The company already holds similar patents in the U.S., Mexico, Australia and Israel, with applications pending in Europe and Brazil.
• Bausch + Lomb announced it as resolved its patent infringement lawsuit vs. Vitamin Health, Inc. filed in September 2013 in the U.S. District Court for the Western District of New York.  Among other claims, the lawsuit accused Vitamin Health of infringing B+L’s U.S. patent covering PreserVision® AREDS and AREDS 2.
• BioTime, Inc. and its subsidiary, Cell Cure Neurosciences, Ltd. announced an abstract evaluating OpRegen® in patients with advanced dry age-related macular degeneration (dry-AMD) based on the ongoing Phase I/IIa clinical trial will be presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2017. BioTime also announced it expects expansion of OpRegen into the initial U.S. clinical sites in the coming weeks, and further data from cohort 2 in the first half of 2017 with cohort 3 enrollments starting in the coming months.
• And Genentech, a member of the Roche Group, announced the U.S. FDA has accepted its Supplemental Biologics License Application (sBLA) for Actemra® (tocilizumab) for the treatment of giant cell arteritis (GCA) — a chronic, potentially life-threatening autoimmune condition that can cause visual symptoms and, if left untreated, can lead to blindness.