Eyes on New Product Development

• Alimera reached an agreement with MEAgate International to distribute Ilveuin^® (fluocinolone acetonide intravitreal implant) in the Middle East (December 2015).

• Allegro completed enrollment in its DEL MAR phase 2b trial that is evaluating the safety and efficacy of Luminate^® (ALG-1001) in patients with DME (January 2016).

• Can-Fite's subsidiary, OphthaliX, completed patient enrollment for its phase 2 trial of CF101, an A3 adenosine receptor agonist, in the treatment of glaucoma (December 2016).

• Delcath launched a phase 3 trial of its Delcath Hepatic Delivery System and melphalan HCl designed for the treatment of hepatic dominant ocular melanoma (January 2016).

• Dompe announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has officially designated recombinant human Nerve Growth Factor (rhNGF) as an orphan drug for the treatment of neurotrophic keratitis (December 2015).

• Eleven Biotherapeutics reported phase 3 data on isunakinra (EBI-005) in allergic conjunctivitis (January 2016).

• Envisia has dosed its first patient in the second cohort of the phase 2 clinical program evaluating ENV515, an extended-release formulation of travoprost (January 2016).

• Eyegate started enrollment in a confirmatory phase 3 clinical trial of its EGP-437 combination product in patients with noninfectious anterior uveitis (January 2016).

• Glaukos is initiating a phase 2 study of a travoprost intraocular implant with the iDose delivery system in patients with glaucoma (January 2016).

• Mundipharma Ophthalmology Products licensed Merck's glaucoma products in Australia, Canada, Latin America, Middle East, Africa, and New Zealand (December 2015).

• Ocular Therapeutix announced that the U.S. FDA has accepted for review its New Drug Application (NDA) for Dextenza™ (sustained release dexamethasone) intracanicular depot for the treatment of ocular pain after ophthalmic surgery. The firm also completed a phase 2 study of this product in the treatment of patients with dry eye (December 2015).

• PanOptica announced interim results of a phase 1/2 study of PAN-90806, a topical antivascular endothelial growth factor eyedrop for the treatment of neovascular eye diseases (November 2015).

• pSivida plans to file for European marketing approval of Medidur™ (fluocinolone acetonide intravitreal implant) for chronic noninfectious uveitis of the posterior segment of the eye based on data from a single pivotal trial (December 2015).

• ThromboGenics started enrollment in a phase 2 study evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total PVD in patients with nonproliferative diabetic retinopathy (January 2016).

• The U.S. FDA approved several abbreviated NDAs for generic olopatadine HCl ophthalmic solution 0.1% (Apotex, Sandoz, Wockhardt, Watson, Zach, Aurobindo and Novel Labs, December 2015).

• Alexion received U.S. FDA approval for Kanuma^® (sebelipase alfa), an enzyme therapy indicated for the treatment of patients with lysosomal acid lipase deficiency. Kanuma is a biologic that is manufactured from chickens that express the biological product in its egg whites. It was a unique regulatory action, involving a new animal drug approval for the genetically engineered chickens, as well as designation as an orphan product, breakthrough therapy, priority review, and rare pediatric disease priority review voucher (December 2015).

• Allergan received U.S. FDA approval for BOTOX^® (onabotulinumtoxinA) for the treatment of adults with lower limb spasticity. It was previously cleared for the treatment of upper limb spasticity in March 2010 (January 2016).

The firm also acquired Anterios, Inc., a clinical stage biopharmaceutical company developing a delivery system and botulinum toxin-based prescription products (January 2016).

• Bial-Portela's phase 1 trial in France of an oral neurological drug resulted in the death of a subject and serious injury in 4 additional subjects (January 2016).

• The U.S. Government Accountability Office found flaws in the way the FDA tracked drugs after they came to the market (January 2016).

• U.S. Senators Chuck Grassley (R, IA) and Sen John McCain (R, AZ) urged Sylvia Burwell, secretary of Health and Human Services, to authorize increased importation of less expensive prescription drugs from Canada and possibly other countries (January 2016).

• U.S. Vice President Joe Biden said that the United States would speed up the approval of promising new drug combinations in a newly announced drive to cure cancer “once and for all” (January 2016).

• Valeant Pharmaceuticals is partnering with Walgreens in distributing its medications to patients (December 2015).