Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Allergan plc's wholly-owned subsidiary Allergan Pharmaceuticals International Limited, and genome editing company Editas Medicine, Inc., have entered into a strategic research and development alliance under which Allergan will receive exclusive access and the option to license up to five of Editas Medicine's genome-editing ocular programs, including its lead program for Leber Congenital Amaurosis (LCA10), which is currently in pre-clinical development. The agreement covers early stage, first-in-class ocular programs targeting serious diseases based on Editas Medicine's unparalleled CRISPR genome editing platform, including CRISPR/Cas9 and CRISPR/Cpf1. Editas Medicine's lead program is being developed for the potential treatment of the rare, inherited retinal degenerative disease LCA10.
- BioTime, Inc. announced the expansion of its ongoing Phase I/IIa clinical trial for OpRegen® in the advanced dry form age-related macular degeneration (dry-AMD) by naming the first two sites that will treat patients in the U.S. OpRegen is reportedly an investigational therapy in which retinal pigment epithelial (RPE) cells are introduced into the subretinal space where they are intended to replace missing RPE cells.
- Ocular Therapeutix, Inc. announced positive results of a patient experience study of DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use. The study, published in Patient Preference and Adherence, reportedly evaluated the overall patient experience and perceived value of DEXTENZA following cataract surgery. According to the results, 92 percent of patients reported the highest level of overall product satisfaction, with 88 percent saying they would request the insert if they were to undergo cataract surgery again.
- Privately-held biopharmaceutical company Tyrogenex has completed patient enrollment in the APEX Study — a phase 2 trial of X‐82 (vorolanib) for the oral treatment of wet age-related macular degeneration (wAMD). The APEX study is reportedly a randomized, double‐masked, placebo‐controlled, dose‐finding, non-inferiority study of X‐82 plus as‐needed intravitreal anti‐VEGF compared to as‐needed intravitreal anti‐VEGF alone in patients with neovascular AMD.
- Nicox S.A. announced resubmission of the New Drug Application (NDA) for AC-170 — its novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The brand name provisionally approved by the U.S. FDA for AC-170 is ZERVIATE.
- Alimera Sciences, Inc. announced its European subsidiary, Alimera Sciences Limited, has signed an exclusive agreement with Brill Pharma S. L. (Brill Pharma), Barcelona, Spain, for distribution of ILUVIEN® — Alimera's sustained release intravitreal injection for the treatment of diabetic macular edema — in the Kingdom of Spain.
- And a recent report of biotech innovations driving cannabinoid-based pharmaceutical market growth mentioned Canada-based InMed Pharmaceuticals, Inc. has a second product candidate, INM-085, targeting glaucoma that was also being developed for topical eye drop application. INM-085 would reportedly be the first glaucoma treatment designed to be a multi-mechanism, multi-target of action therapy based on cannabinoids.
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