Ophthalmology Therapeutic Roundup — October 20, 2016

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

• Genentech — a member of the Roche Group — recently received U.S. FDA approval for its Lucentis® (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is reportedly the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions.
• Clinical stage biotechnology company Envisia Therapeutics recently released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also reportedly demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (Xalatan® and Lumigan®).
• PanOptica, Inc. reported positive data from a Phase 1/2 study of PAN-90806 — a topical anti-vascular endothelial growth factor (anti-VEGF) eye drop in development for the treatment of neovascular eye diseases. Based on these results, the company reportedly plans to initiate a Phase 1/2 clinical trial of a next-generation formulation of topical PAN-90806 in patients with neovascular age-related macular degeneration (wet AMD) in 2017.                
• Quark Pharmaceuticals recently launched EyeActNow.com — a website designed to promote public awareness and subject recruitment for a global Phase II/III clinical study evaluating the investigational drug QPI-1007, which is designed to stop further vision loss in patients with early diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION). The study, known as QRK207, seeks to evaluate the safety and efficacy of QPI-1007, a novel siRNA (small interfering RNA) drug candidate for ocular neuroprotection.
• Spark Therapeutics recently announced it will be offering physicians and eligible patients access to genetic testing and counseling for more than 30 genes linked to certain forms of inherited retinal diseases (IRDs) to help those affected get the support and information they need. Additionally, Spark presented one-year efficacy data from the crossover group and two-year durability data from the original intervention group for the Phase 3 trial of voretigene neparvovec (formerly SPK-RPE65) during Retina Subspecialty Day at the American Academy of Ophthalmology 2016 Annual Meeting in Chicago. And Spark has entered into a multi-year research agreement with Dr. Guangping Gao, at the University of Massachusetts Medical School to identify adeno-associated virus (AAV) vectors from a proprietary library of AAV capsids and evaluate their efficacy, with the goal of enhancing the efficiency of gene delivery to cells in the retina, liver and central nervous system.
• SciFluor Life Sciences, Inc. reported the first patients have been dosed in both Phase I/II trials of SF0166 Topical Ophthalmic Solution, which is being evaluated as a potential new treatment for diabetic macular edema (DME) and age-related macular degeneration (wet AMD).
• ThromboGenics recently offered a third quarter business update, reporting the company is continuing to advance its portfolio of novel medications for the treatment of diabetic eye disease, and is conducting a Phase IIa clinical study (CIRCLE) evaluating THR-409 (ocriplasmin) to induce a complete posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
• And global specialty pharmaceutical company Mallinckrodt plc has awarded a $3 million Healthcare Advancement Grant to Children's National Health System to support a three-year outcomes research initiative focused on pediatric patients in the intensive care setting. And the company plans to provide 160,000 drug deactivation pouches to families in Kentucky as well as across the U.S. Midwest and Central Appalachia to encourage the safe and responsible disposal of leftover prescription pain medications.