Ophthalmology Therapeutic Roundup — August 10, 2017

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

• Allegro Ophthalmics, LLC reported its DEL MAR Phase 2b Stage 2 clinical trial met its primary endpoint when used as a sequential therapy in patients with diabetic macular edema (DME). The study reportedly evaluated Luminate® as a sequential therapy or in combination therapy with anti-VEGF in 80 patients with DME.  The 1.0 mg dose of Luminate in sequential therapy reportedly demonstrated visual acuity gains equivalent at all time points to bevacizumab monotherapy, and again showed 12-week durability after the completion of three loading doses.
• Ocugen, Inc. announced the U.S. FDA has granted orphan drug designation (ODD) for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease (oGVHD). The ODD will reportedly allow the company to further advance the clinical development of OCU300, with a proprietary nanoemulsion, into a phase 3 clinical trial in the near future.
• Applied Genetic Technologies Corporation (AGTC) announced the U.S. FDA has granted an orphan drug designation for its gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene. In June 2016, the company reportedly announced that the European Commission (EC) granted orphan medicinal product designation for the same indication. Additionally, researchers from the University of Pennsylvania recently announced the publication of preclinical proof of concept data supporting the clinical development of a gene-based therapy for the treatment of XLRP developed by AGTC.
• Valeant Pharmaceuticals International, Inc. announced it had received a Complete Response Letter (CRL) from the U.S. FDA regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% — an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The CRL from the FDA reportedly only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla. The FDA reportedly did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
• Clearside Biomedical, Inc. completed patient enrollment in its Phase 3 PEACHTREE clinical trial to evaluate the safety and efficacy of CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”) — the company’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide, for the treatment of macular edema associated with non-infectious uveitis.
• Guardion Health Sciences, Inc. recently completed their Series B funding round, raising an aggregated total of $3.105 million. The company reportedly plans to use the proceeds to accelerate expansion of their operations, implement their sales and marketing strategy, and complete development of additional products in their pipeline.
• Aerpio Pharmaceuticals, Inc. announced shares of the Company’s common stock have been cleared for trading on the OTC Market Group's OTCQB® Market in the United States. Shares of Aerpio’s common stock will reportedly trade under the ticker symbol "ARPO", effective at the market open on August 8, 2017.

Like what you read? Follow OphthalmologyWeb to keep up with our latest articles, news and events. Plus, get special offers and more delivered to your inbox.