Ophthalmology Therapeutic Roundup — November 3, 2016

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

• Aerie Pharmaceuticals, Inc. recently reported successful 90-day topline efficacy results of its Rocket 4 Phase 3 clinical trial of product candidate Rhopressa™ — a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Additionally, Aerie announced it has withdrawn the Rhopressa NDA (new drug application) that was submitted to the FDA in the third quarter of 2016. The filing was reportedly withdrawn as the result of a third-party manufacturing facility in Tampa, Fla. not being ready for pre-approval inspection by the FDA. The drug product contract manufacturer has advised Aerie and the FDA that it expects to be prepared for FDA inspection in January 2017, and Aerie expects to resubmit the Rhopressa NDA filing at that time.
• Glaukos Corporation recently announced a study of 134 predominantly Hispanic eyes with open-angle glaucoma (OAG) showed mean intraocular pressure (IOP) of 12.9 mm Hg and a 61 percent decrease in mean medication burden one year following implantation of the iStent® Trabecular Micro-Bypass Stent in combination with cataract surgery.
• Ophthotech Corporation reported the Phase 2b study results of Fovista® (pegpleranib) — the company's anti-PDGF agent administered in combination with Lucentis® (ranibizumab) anti-VEGF therapy for the treatment of wet age-related macular degeneration (AMD) — have been published online in Ophthalmology®, the journal of the American Academy of Ophthalmology. The article reportedly indicates Ophthotech's Fovista (1.5 mg), administered in combination with Lucentis, met the pre-specified primary efficacy endpoint of mean change in visual acuity.
• Allergan plc recently received U.S. FDA approval for Restasis Multidose™ (Cyclosporine Ophthalmic Emulsion) 0.05% — a preservative-free, multi-dose bottle offering the same preservative-free formulation of Restasis since the launch in 2003. The product is reportedly designed with a patented unidirectional valve and air filter technology that eliminates the need for a preservative.
• Imprimis Pharmaceuticals, Inc. has filed for registration of its recently-constructed New Jersey facility with the U.S. Food and Drug Administration (FDA) as a 503B outsourcing facility.  The state-of-the-art facility is expected to begin manufacturing as an outsourcing facility in December 2016 and dispensing medications in early first quarter 2017. Imprimis reportedly designed the facility for the production of its core ophthalmology formulations.