Ophthalmology Therapeutic Roundup — November 10, 2016

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

• Clinical stage drug development company RegeneRx Biopharmaceuticals, Inc. announced the first patients have been enrolled in a Phase 3 clinical trial (ARISE-2 trial) with RGN-259 (Thymosin beta 4) — a sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.
• Glaukos Corporation reported announced a recent study showed 100 percent of 57 phakic eyes with open-angle glaucoma achieved a ≥ 20% reduction in unmedicated intraocular pressure (IOP) one year after implantation of the iStent inject® Trabecular Micro-Bypass in a standalone procedure. The study was recently published in the journal Advances in Therapy.
• Nicox S.A. provided an update on the regulatory status of its key projects, latanoprostene bunod and AC-170. Valeant Pharmaceuticals International, Inc., has stated that Nicox's licensee for latanoprostene bunod, Bausch + Lomb, is currently addressing the issues identified by the U.S. FDA and anticipates being ready for inspection by the end of the year. And since Nicox received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for AC-170, Nicox has remained in close contact with the relevant manufacturing parties who are actively working to address the FDA's concerns as soon as possible and expects to meet with the FDA during the fourth quarter of 2016 regarding resubmission next steps.
• And a special issue of the journal Drug Delivery and Translational Research will be focused on ocular drug delivery. The issue will reportedly include articles by recognized global experts and researchers in the field of ophthalmic drug delivery, covering a broad spectrum of drug delivery topics including current challenges faced with regard to the ocular barriers presented and establishment of suitable models to drive future technology success.