Ophthalmology Therapeutic Roundup — February 16, 2017

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

• Imprimis Pharmaceuticals has started shipping its core sterile ophthalmic medications to select customers from its FDA-registered outsourcing facility without the need for a patient-specific prescription. Over the next few weeks, Imprimis' flagship Dropless Therapy® injectable and LessDrops® topical formulations will reportedly become available to all customers.
• Biotechnology company REGENXBIO Inc. announced its Investigational New Drug application (IND) is active for the planned multi-center, open-label, multiple-cohort, dose-escalation Phase I clinical trial of RGX-314 for the treatment of wet age-related macular degeneration (AMD). The goal of the RGX-314 program is reportedly to develop a single-dose treatment for wet AMD that prevents future disease recurrence, while reducing or eliminating the need for regular injections that are the current standard of care in wet AMD.
• Shire Pharma Canada ULC has filed a New Drug Submission (NDS) with Health Canada for the marketing authorization of lifitegrast for the treatment of dry eye disease in adults in Canada. The lifitegrast submission is supported by five clinical trials with more than 2,500 patients. If approved, Canada will be the first country to receive marketing authorization for lifitegrast after the U.S.
• Glaukos Corporation reported it has completed patient enrollment in the pivotal phase of its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial for the iStent SUPRA® Suprachoroidal Micro-Bypass Stent. The clinical trial will reportedly include 36 sites and 505 subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.
• Resverlogix Corp. recently highlighted two potentially new indications recently identified by third party academic research involving its lead drug, apabetalone. One of these indication, published in the Journal of Neuroinflammation, reportedly described the inhibition of bromodomain and extra-terminal (BET) epigenetic readers, including apabetalone (RVX-208), as having therapeutic potential in degenerative diseases of the eye (retinal).
• Noveome Biotherapeutics, Inc. reported publication of preclinical data in a multiple sclerosis (MS) model with ST266 — the company’s novel secretome. Intranasally delivered, ST266 reportedly demonstrated anti-inflammatory activity and prevented retinal ganglion cell (RGC) loss in the optic nerve, showing its therapeutic potential for treating optic neuritis — the most common presenting sign of MS.

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