Ophthalmology Therapeutic Roundup — October 13, 2016

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

• Ocular Therapeutix, Inc. has entered into a strategic collaboration, option and license agreement with Regeneron Pharmaceuticals, Inc., through which they will collaborate on the development of a sustained release formulation of the vascular endothelial growth factor (VEGF) trap aflibercept for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases. Ocular Therapeutix also recently offered an update on its development strategy, reporting it was currently developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with both small and large molecule pharmaceuticals, such as tyrosine kinase inhibitors (TKIs) and protein-based anti-vascular endothelial growth factors (VEGFs) respectively, with the goal of delivering sustained and therapeutic levels of drugs to targeted ocular tissues.
• Biotechnology company Allegro Ophthalmics, LLC recently announced its DEL MAR Phase 2b clinical trial evaluating Luminate® (ALG-1001) in 136 patients with diabetic macular edema (DME) met its primary and secondary endpoints, demonstrating promising visual acuity gains and reduction in central macular thickness (CMT) that were equivalent to bevacizumab monotherapy.
• Genentech, a member of the Roche Group, recently announced the U.S. FDA has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis® (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV) — a complication of severe near-sightedness that can lead to blindness. The sBLA is reportedly based on results from the company's Phase III RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy, reportedly the only treatment currently approved by the FDA for mCNV.
• Ophthalmic R&D company Nicox S.A. has received a Complete Response Letter (CRL) from the U.S. FDA regarding the New Drug Application (NDA) for AC-170 — a novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. According to Nicox, the FDA's stated reason for the CRL pertains solely to a Good Manufacturing Practice (GMP) inspection at a third party facility producing the active pharmaceutical ingredient (API) cetirizine and supplying it to the manufacturer of the finished product.
• RXi Pharmaceuticals Corporation recently had an article published about the company called "Age-Related Macular Degeneration: On the Rise as Baby Boomers Age" in Western Pennsylvania Healthcare News. The company will be presenting an overview of its novel self-delivering RNAi (sd-rxRNA®) technology at the 15th Annual BIO Investor Forum on October 18, 2016 in San Francisco. Additionally, the company recently announced it has entered into an exclusive option agreement to acquire all outstanding capital stock of MirImmune Inc. — a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer.
• And a team of three graduate students from the University of Southern California are finalists in the 2016 Collegiate Inventors Competition for their project, "AesculaGel: Thermally Responsive Hydrogels for Ocular Drug Delivery." AesculaGel is reportedly a sustained drug delivery gel that is inserted directly into the tear duct by a doctor four times a year, and the students believe their project could be used as a method for more precise dosing for the treatment of glaucoma.