Eyes on New Product Development

Abstract

In the recent period, Valeant announced plans to acquire Bausch+Lomb, several other deals were announced, two companies completed enrollment in Phase 2 trials, and a third company is planning to enter Phase 3 with a novel treatment for neovascular age-related macular degeneration (AMD). Ocriplasmin, a new treatment for symptomatic vitreomacular adhesion has been launched in several countries in Europe, while other firms continue their efforts with European regulatory agencies for availability. The U.S. Federal government is dealing with the issues of compounding pharmacies and patenting of human genes.

Ophthalmic Pharmaceuticals

• Alimera Sciences announced that the Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence (NICE) has issued a positive Appraisal Consultation Document (ACD) on Iluvien^® (fluocinolone acetonide intravitreal implant) for the treatment of pseudophakic patients with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies (June 2013).

• Eleven Biotherapeutics entered into a collaboration with ThromboGenics NV to research and develop a protein therapeutic based on a novel biologic target employing Eleven's AMP-Rx protein design technology (May 2013).

• iCo Therapeutics, Inc. announced its completed enrollment of its Phase 2 iDEAL study evaluating the efficacy and safety after repeated injections of iCo-007 in patients with Diabetic Macular Edema (DME, June 2013).

• MorphoSys AG announced that it received a milestone payment from Novartis in connection with the clinical trial application (CTA/IND) and projected initiation of a Phase 1 clinical trial of a HuCAL-derived, fully human antibody for ophthalmology (May 2013).

• Ocular Therapeutix completed enrollment in a Phase II study of their sustained-release, intracannicular dexamethasone for the treatment of postoperative inflammation and pain (June 2013).

• Omeros Corporation announced that the European Medicines Agency (EMA) has confirmed that the Company's planned Marketing Authorization Application (MAA) for OMS302 can be submitted and reviewed under the EMA's centralized procedure (April 2013).

• Opthotech announced that they are proceeding to Phase 3 in the third quarter of 2013 for their anti-platelet-derived growth factor (PDGF), in combination with anti-VEGF therapy for the treatment of neovascular AMD.

• ThromboGenics announced that its partner Alcon has launched JETREA^® (ocriplasmin) in Germany, United Kingdom, Denmark, and Sweden (May 2013).

• Valeant Pharmaceuticals agreed to buy Bausch + Lomb (May 2013).

Ophthalmic diagnostics

• Nicox has entered into an exclusive agreement with Immco Diagnostics, Inc. to promote a CLIA-approved proprietary laboratory test combining three novel biomarkers (SP-1, CA-6, and PSP) and the traditional markers (ANA, Ro, La, and RF) targeted at early detection and diagnosis of Sjögren's Syndrome to eye care professionals in North America (June 2013).

Regulatory, Government and Pharmaceutical Industry

• Potiga™ (Ezogabine), a epilepsy therapy, was linked to retinal abnormalities and blue discoloration of the sclera, conjunctiva, and skin (April 2013).

• The American Academy of Ophthalmology (AAO) is advocating for removal of two sections of the pending U.S. safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act). The AAO is seeking exemptions from Sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation (May 2013).

• The U.S. Supreme Court ruled that human genes isolated from the body cannot be patented (June 2013).

Footnotes

Author Disclosure Statement

The author consults for numerous ophthalmic pharmaceutical and medical device firms.