Eyes on New Product Development

• Adenovir Pharma started a phase 2 clinical study for the pharmaceutical treatment of epidemic keratoconjunctivitis (January 2014).

• Alimera Sciences resubmitted an NDA to the U.S. Food and Drug Administration (FDA) for Iluvien® (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (March 2014). The firm also announced that it signed an exclusive 5-year agreement with Specialised Therapeutics Australia for the distribution of this product in Australia and New Zealand (April 2014).

• Amakem announced that treatment has started in a phase 2 dose-ranging study of AMA0076, a rho kinase inhibitor, for the treatment of glaucoma (May 2014).

• Avedro received a complete response letter from the FDA regarding its NDA for riboflavin ophthalmic solution/KXL System to treat keratoconus and corneal ectasia after refractive surgery (April 2014).

• BioLight Israeli Life Sciences Investments announced that its subsidiary ViSci has filed an IND application with the FDA to conduct a phase 1/2a clinical study with its subconjunctival latanoprost controlled-release insert for the treatment of glaucoma (March 2014). The firm also received a U.S. patent for this product (May 2014).

• ForSight VISION5 has completed enrollment in its phase 2 clinical study for the Helios™ ocular insert for the treatment of glaucoma and ocular hypertension (April 2014).

• Gene Signal announced data from phase 3 trial of aganirsen eye drops for corneal neovascularization due to inflammation (May 2014).

• Icon Bioscience reported that IBI-10090, an intraocular implant of dexamethasone, is in a pivotal phase 3 study to treat inflammation associated with cataract surgery (May 2014).

• Lupin acquired Mexico's Laboratorios Grin (March 2014).

• Nicox announced that its subsidiary Eupharmed has licensed Italian rights to Cationorm®, a Santen cationic oil-in-water product for the treatment of dry eye symptoms (May 2014).

• Novaliq commenced a phase 1 study for CyclASol (cyclosporine solution), recently gaining U.S. and European patent approval for the treatment of dry eye syndrome (April 2014).

• Novartis/Alcon received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for Simbrinza®, a fixed-dose combination of brinzolamide and brimonidine to treat glaucoma (May 2014).

• Novartis entered into an agreement with Ophthotech Corp. to commercialize the biopharmaceutical company's treatment for wet age-related macular degeneration, Fovista™, outside the United States (May 2014).

• Ohr Pharmaceutical has completed the enrollment of its OHR-002 (Squalamine Eye Drops) phase 2 clinical trial for the treatment of wet age-related macular degeneration (April 2014). The firm has acquired the technology assets of SKS Ocular Technologies to deliver drugs, including small molecules and biologics, for extended durations (May 2014).

• Parion Sciences announced that it received FDA acceptance of its IND application for P-321 Ophthalmic Solution, an inhibitor of the epithelial sodium channel for the treatment of dry eye disease (May 2014).

• Quark has completed a safety study of the intravitreal injection of QPI-1007, a small interfering RNA inhibitor of capsase-2, to treat nonarteritic anterior ischemic optic neuropathy (April 2014).

• R-Tech Ueno is developing unoprostone for the treatment of age-related macular degeneration (April 2014).

• Santen Pharmaceutical Co., Ltd., announced that SAKURA (Study Assessing double-masKed Uveitis tReAtment) Study 1, the first of two global phase 3 studies evaluating intravitreal injections of sirolimus in patients with noninfectious posterior-segment uveitis, met its primary endpoint (April 2014). Santen entered into an agreement with Merck for its branded prescription ophthalmic products in Japan, Europe, and Asia Pacific.

• Shire has completed dosing and presented results for lifitegrast in the treatment of dry eye for two studies: e OPUS-2 (a phase 3 placebo-controlled efficacy and safety study) and SONATA (a safety study in normal volunteers) (April 2014).

• Spark Therapeutics and Genable Technologies have entered into a collaboration agreement for Genable's lead therapeutic to treat rhodopsin-linked autosomal dominant retinitis pigmentosa, GT038 (March 2014).

• France introduced a measure allowing pharmacists to substitute prescribed brand-name biotech drugs with biosimilar versions in its 2014 healthcare budget (April 2014).

• The FDA Center for Devices and Radiological Health proposed speeding up medical device approvals for patients who have no other treatment options through a new program called the Expedited Access Premarket Approval Application (April 2014).

• The FDA selected University of California, San Francisco (UCSF), as the site of a new regulatory science center on the West Coast. The center, which will be a joint effort between scientists in the UCSF School of Pharmacy and Stanford University, aims to spur innovative approaches in drug development that will support the FDA's ability to evaluate and approve safe and effective new medications (May 2014).

• The FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events. It is convening a panel of experts to define techniques to reduce preventable harm. The FDA notes that effectiveness and safety of epidural administration of corticosteroids have not been established, and it has not approved corticosteroids for this use (April 2014).