Ophthalmology Therapeutic Roundup — January 12, 2017

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

• Clinical stage ophthalmology company Acucela Inc. — a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. — has received U.S. FDA drug designation for its leading drug candidate emixustat hydrochloride (“emixustat”) for the treatment of Stargardt disease.
• IACTA Pharmaceuticals, Inc. has acquired the North American rights to develop and commercialize NM133 — an investigational medicine designed to help treat dry eye — from its developer, Nanomerics, Ltd. NM133 is reportedly a nano-enabled form of cyclosporine A that is being investigated for the treatment of dry eye.
• New drug development company Lin Bioscience Inc. has licensed a first-in-class therapeutic program designed to slow or halt the progression of atrophic "dry" age-related macular degeneration (AMD) from Columbia University. The oral therapeutic candidate, LBS-008, is reportedly expected to enter Phase 1 clinical trials in 2017 for dry AMD, as well as for Stargardt Disease as an orphan indication.
• ForSight VISION4, a privately-held biotechnology company developing drug delivery for the treatment of retinal diseases, has been acquired by Roche Holdings Inc. The acquisition reportedly expands Roche's exclusive access to the ForSight VISION4 PDS technology for long acting delivery of therapeutics to the eye.
• Auven Therapeutics has closed the sale of its portfolio company Ocular Technologies Sarl to Sun Pharmaceutical Industries. Additionally, the company reported Seciera™, which was discovered and developed by Ocular Technologies, achieved positive top-line results in a confirmatory Phase 3 clinical trial in dry eye disease.
• Specialty pharmaceutical company Novaliq GmbH announced positive Phase 2 results evaluating CyclASol® — a clear, preservative-free cyclosporine A solution — in 207 patients with moderate to severe dry eye disease (DED). CyclASol reportedly showed a consistent reduction in corneal fluorescein staining, the primary sign endpoint, with an early onset of action over the four-month treatment period.
• Spark Therapeutics announced new four-year data from a Phase 1 clinical trial and natural history study findings that enhance the understanding of investigational voretigene neparvovec — a one-time adeno-associated viral (AAV) gene therapy for Inherited Retinal Disease (IRD) caused by biallelic RPE65 mutations. Additionally, the U.S. FDA has granted a request to amend the orphan drug designation for voretigene neparvovec to "the treatment of inherited retinal dystrophy due to biallelic RPE65 mutations."
• Clearside Biomedical, Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Number 15/086,485 entitled, “Methods and Devices for the Treatment of Ocular Diseases in Human Subjects.” Once the administrative process is complete, the U.S. Patent that issues from this application will provide intellectual property protection for methods of treating posterior ocular disorders by non-surgically administering axitinib to the suprachoroidal space of the eye.
• Swiss company Xigen recently reported successful Phase II results for its lead compound Brimapitide (XG-102) in the American Journal of Ophthalmology. Xigen’s innovative technology platform enables the design and synthesis of long-acting therapeutic peptides with a very high metabolic stability.
• ThromboGenics NV recently enrolled the first patients for its Phase II study evaluating the safety and efficacy of two dose levels of THR-317 for the treatment of diabetic macular edema (DME). The trial will also assess THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME.
• 4D Molecular Therapeutics recently announced enrollment of the first participant in its Choroideremia Natural History Study (NHS) towards developing a gene therapy product for the treatment of Choroideremia (CHM). Two clinical sites are reportedly actively recruiting for the study — the Retina Foundation of the Southwest in Dallas and Retina Vitreous Associates of Los Angeles.
• Nicox S.A. is finalizing the design of a first-in-human Phase 2 clinical trial to evaluate efficacy and safety of NCX 4251 — an ophthalmic suspension of fluticasone propionate nanocrystals as a topical treatment for acute exacerbation of blepharitis. The company plans to initiate Phase 2 during the fourth quarter of 2017 and expects the trial to take about one year to complete.
• Okogen, Inc. has reportedly secured ophthalmic contract research organization Ora, Inc. to conduct clinical studies and lead the regulatory strategy of OKG-0301 for the treatment of adenoviral conjunctivitis.
• Aerie Pharmaceuticals, Inc. has entered into a lease agreement with the Industrial Development Agency (IDA) of Ireland for a new manufacturing plant in Athlone, Ireland. This will reportedly be Aerie's first manufacturing plant, where the company plans to produce commercial supplies of Aerie’s current product candidates, Rhopressa™ and Roclatan™.
• TOT Biopharm Co., Ltd. has signed an exclusive licensing agreement with Lee's Pharmaceutical Holdings for its monoclonal antibody drug TAB014 that can be used to treat wet age-related macular degeneration (wAMD) and other eye diseases.
• Trefoil Therapeutics Inc. announced it has raised $5.2 million in Series 1 financing, which will reportedly help provide funding and research support that will allow the company to progress toward an Investigational New Drug (IND) filing. Trefoil is reportedly developing TTHX1114 as the first therapeutic application for the treatment of Fuchs endothelial corneal dystrophy (FECD).