Ophthalmology Therapeutic Roundup — December 1, 2016

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

• Omeros Corporation recently announced the successful outcome of its completed post-marketing clinical trial of the effect of OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% in pediatric patients undergoing cataract surgery. OMIDRIA is approved by the FDA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and is not currently approved for use in patients less than 18 years of age.
• Eyenovia Inc. has published its Phase II results showing the company's micro-formulation achieved either equivalent or greater biologic effect compared to standard eye drop therapy. The study was reportedly conducted in more than 100 subjects who received high-precision micro-formulation of 6µL of a dilatory agent versus standard eye dropper dosing of 40-50µL to compare the pharmacodynamic outcome of pupillary dilation measured by digital pupilometry.
• Santen Pharmaceutical Co., Ltd. recently announced topline results of its SAKURA global clinical development program designed to confirm the efficacy, safety, and optimal dose between three active doses of sirolimus intravitreal injection as monotherapy for patients with non-infectious uveitis of the posterior segment. The SAKURA Program reportedly met its objective, demonstrating that OPSIRIA (440 µg sirolimus injection, development code: DE-109) can effectively and safely reduce intraocular inflammation (as measured by vitreous haze).
• EyeGate Pharmaceuticals, Inc. announced following a pre-submission meeting with the U.S. FDA, it plans to pursue U.S. regulatory clearance of its EyeGate Ocular Bandage Gel (OBG) via the De Novo 510(k) pathway. EyeGate OBG is the lead product candidate from the company’s cross-linked, thiolated carboxymethyl hyaluronic acid (CMHA-S) platform.
• jCyte completed enrollment for a phase I/IIa trial to study the safety of its stem cell therapy candidate for retinitis pigmentosa (RP). The trial will reportedly include 18 patients with advanced RP, eight of whom have completed the one-year study.
• Portage Biotech Inc. announced the formation of EyeGen, Ltd. — a new ophthalmic company focused on developing preclinical ophthalmology assets through proof of concept. EyGen’s lead asset is PPL-003, a potent anti-inflammatory created by Portage Pharmaceuticals Limited and being developed for topical ophthalmic delivery in patients with ocular surface and anterior segment diseases.
• Spotlight Innovation Inc. recently announced it has made a strategic investment in medical device company Solx, Inc., which develops innovative surgical technologies that treat glaucoma and preserve vision. Solx's lead product is reportedly the SOLX Gold Shunt™ — an implantable drainage device designed to reduce elevated IOP associated with refractory glaucoma without creating a bleb.
• Paragon BioTeck, Inc. announced a ruling recently handed down by the U.S. Patent and Trademark Office affirming claims made by Paragon in the patent for its R-phenylephrine hydrochloride formulation. This ruling reportedly reinforces the science underlying the formulation of the company's Phenylephrine Hydrochloride Ophthalmic Solution, used by ECPs to attain mydriasis for conducting an ocular examination. 
• BioLineRx Ltd. has signed an exclusive, worldwide agreement with Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., for the in-licensing of a novel anti-inflammatory treatment for Dry Eye Syndrome (DES). This project, to be named BL-1230, is reportedly the third project in-licensed under the framework of the company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.
• Innovent Biologics, Inc. has raised $260 million in Series D financing to help accelerate its pipeline of biologic therapeutics. Since its founding in August 2011, Innovent has built a robust portfolio of 12 product candidates, including those for ophthalmology.
• Shire plc plans to expand its operations in Cambridge, Mass. to establish a rare disease innovation hub. Shire and BioMed Realty have reportedly signed a lease for a 343,000-square-foot building at 500 Kendall Street, with occupancy anticipated for Q1 2019.