Eyes on New Product Development

• Alimera Sciences, Inc. received a draft ruling from the U.K.'s National Institute for Health and Clinical Excellence on its Iluvien™ (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema, which was initially negative, and then referred to a subgroup for evaluation of additional information (August and September 2012).

• Allergan, Inc. and Molecular Partners AG announced that they have significantly expanded their existing relationship by entering into 2 separate agreements to discover, develop, and commercialize proprietary therapeutic DARPin^® products for the treatment of serious ophthalmic diseases. The lead molecule is MP0260, a dual anti-VEGF-A/PDGF-B DARP in a small molecule for the treatment of exudative age-related macular degeneration (AMD) and related conditions (August 2012).

• Amakem announced it has initiated a Phase 2a clinical study of its novel Rho kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension (September 2012).

• Bausch+Lomb announced that the U.S. FDA has approved the Lotemax^® (loteprednol etabonate ophthalmic gel (October 2012).

• Bausch+Lomb announced that the U.S. FDA has granted additional labeling indications for its Besivance^® (besifloxacin ophthalmic suspension), including an indication to treat bacterial conjunctivitis infections caused by susceptible isolates of Pseudomonas aeruginosa, as well as Aerococcus viridans, Moraxella catarrhalis, and Staphylococcus warneri (September 2012).

• Dompé announced a clinical trial to evaluate the recombinant human Nerve Growth Factor (rhNGF) for the treatment of neurotrophic keratitis (September 2012).

• Eisai Co., Ltd. and Santen Pharmaceutical Co., Ltd. have entered into an option agreement that grants Santen rights of evaluation and first negotiation for Eisai-owned compounds in the field of ophthalmology (September 2012).

• Ocular Therapeutix completed enrollment for its ReSure™ Sealant (a polyethylene glycol-based hydrogel) in patients undergoing cataract surgery (September 2012).

• Oxford BioMedica and its partner Sanofi announced safety results of the RetinoStat^® Phase I study in neovascular (wet) AMD and the StarGen™ Phase I/IIa1/2a study in Stargardt disease. Both products are gene delivery agents (August 2012).

• pSivida Corp. reported that its licensee Alimera Sciences has indicated its intention to resubmit its application for ILUVIEN^® for diabetic macular edema to the FDA (August 2012).

• Regeneron Pharmaceuticals announced that the U.S. FDA has approved EYLEA^®. (aflibercept) injection for the treatment of Macular Edema following Central Retinal Vein Occlusion. This product was also approved in Japan for the treatment of wet AMD (September 2012).

• Roche announced that, Lucentis^® (ranibizumab) was approved by the U.S. FDA for the treatment of diabetic macular edema (August 2012).

• Sigma-Tau Pharmaceuticals announced that the FDA has approved Cystaran (cysteamine ophthalmic solution) 0.44%, a topical ophthalmic therapeutic for treating corneal cystine crystal accumulation due to cystinosis (October 2012).

• Ten leading biopharmaceutical companies announced they have formed a nonprofit organization to accelerate the development of new medicines, TransCelerate BioPharma Inc. (September 2012).

• ThromboGenics announced that the U.S. FDA has approved JETREA^® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (October 2012).

• Valeant Pharmaceuticals acquired Visudyne^® (verteporfin for injection) from QLT, Inc. (September 2012).

• InSite Vision announced preclinical drug delivery data on DuraSite 2^®, an enhancement on its existing DuraSite, used in marketed ophthalmic products (September 2012).

• Ocular Therapeutix is starting a pilot Phase 2 study to evaluate its travoprost punctum plug for the treatment of elevated intraocular pressure (August 2012).

• Shape Ophthalmics announced clinical data on retention of their punctum plugs and is currently preparing a 510K submission (August 2012).

• The administration of Clinicaltrials.gov was transferred from the National Library of Medicine to the FDA (September 2012).

• The Centers for Disease Control and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New England Compounding Center. The recommendation is related to a multistate outbreak of lethal meningitis from 2 fungi, Aspergillus fumigates and Exserohilum rostratum, among patients who received an epidural corticosteroid injection. Products include methylprednisolone acetate and triamcinolone acetonide (October 2012).

• The U.K. NICE is now recommending Novartis' eye drug Lucentis for the treatment of diabetic macular edema, which reverses its previous draft guidance (October 2012).

• The U.S. FDA announced the formation of an internal task force that will support the development of new antibacterial drugs (September 2012).

• The U.S. National Institutes of Health announced that Christopher P. Austin, M.D., will serve as director of the NIH's newest center, the National Center for Advancing Translational Sciences (NCATS, September 2012).

• U.S. Congressman Ed Markey (D-Mass). introduced HR 6272, a bill to expand the clinical trial registry data bank to cover additional studies, such as Phase 1, bioequivalence, and those conducted outside the U.S. (August 2012).