Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Yesterday, Allergan plc announced the 510(k) Premarket Notification Application for the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) has been accepted for filing by the U.S. Food and Drug Administration (FDA). XEN45 is a minimally invasive implantable crosslinked gelatin shunt used to reduce intraocular pressure (IOP) associated with refractory glaucoma.
- Eleven Biotherapeutics, Inc. announced earlier this week it had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial of EBI-031 — a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling, which may be effective for the treatment of ocular diseases such as diabetic macular edema and uveitis.
- Biotechnology company GenSight Biologics recently announced promising results for its Phase I/II study to demonstrate the safety and tolerability of GS010 in patients with Leber’s Hereditary Optic Neuropathy (LHON). The study reportedly showed visual acuity improvement in patients with an onset of disease of less than two years.
- Last week, Applied Genetic Technologies Corporation (AGTC) announced the European Commission (EC) has granted an orphan medicinal product designation to its investigational gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene. Additionally, AGTC will host a Research Day on Tuesday, June 21, 2016 in New York City that will be live webcasted. The presentation will include scientific collaborators to discuss the range of ophthalmology clinical endpoints, how they are measured, how they define and describe the vision experienced by the patient, and how results in AGTC's clinical development programs could be reported.
- Aerpio Therapeutics, Inc. reported positive clinical results for its Phase 2a study of its lead candidate, AKB-9778, for the treatment of patients with diabetic macular edema (DME). The combination of AKB-9778 (dosed at 15 mg BID subcutaneously) and Lucentis® (ranibizumab injection dosed at 0.3 mg intravitreally) reportedly provided a clinically significant benefit in reduction of macular edema.
- Clinical-stage pharmaceutical company Aerie Pharmaceuticals, Inc. announced today the completion of patient enrollment in Rocket 4 — the company's Phase 3 clinical trial for Rhopressa™ (netarsudil ophthalmic solution) 0.02% intended to satisfy filing requirements in Europe. Rhopressa is a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
- BioTime Inc. and Cell Cure Neurosciences Ltd. reported that the Data Safety Monitoring Board (DSMB) have reviewed initial safety data from the first cohort in the Phase I/IIa clinical trial of OpRegen® — retinal pigment epithelial cells designed for the treatment of the advanced form of dry age-related macular degeneration (dry-AMD). The DSMB has reportedly authorized the OpRegen clinical trial to move forward with enrollment and dose escalation to the second cohort.
- And clinical-stage ophthalmology company Acucela Inc. reported it had received a written termination notice from Otsuka Pharmaceutical Co., Ltd. in regards to the company's product candidate emixustat hydrochloride (“emixustat”) and a development and collaboration agreement for Otsuka's product candidate OPA-6566.