Eyes on New Product Development

• Aerie Pharmaceuticals completed two Phase 2 studies of novel topical ocular hypotensive agents. The first was a fixed-dose combination of AR-12286, a Rho kinase (ROCK) inhibitor, and travoprost. The second was AR-13324, a molecule with activity at both ROCK and the norepinephrine transporter (November 2012).

• Alcon said that its Nevanac^® (nepafenac) ophthalmic suspension has been accepted by the Scottish Medicines Consortium (SMC) for use through the National Health Service in diabetic patients to reduce their risk of postoperative macular edema associated with cataract surgery (November 2012).

• Alimera Sciences, Inc. announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that Iluvien™ (fluocinolone acetonide intravitreal implant) is not recommended for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies (November 2012).

• Bayer HealthCare announced that Eylea^® (aflibercept solution for injection) has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (November 2012).

• Iconic Therapeutics, Inc. completed a Phase 1 study of intravitreal injection of hI-con1™, an all-human, factor VII-IgGFc chimeric protein in patients with wet adult macular degeneration (November 2012).

• Omeros Corporation completed the second of its two pivotal Phase 3 clinical trials evaluating OMS302 (a combination of an anti-inflammatory agent and an agent that causes mydriasis) in patients undergoing intraocular lens replacement surgery (November 2012).

• QLT Inc. completed two Phase 2 clinical studies, PPL GLAU 12 and PPL GLAU 13, of their Latanoprost Punctal Plug Delivery System (L-PPDS) in patients with ocular hypertension and open-angle glaucoma (October 2012).

• SARcode Bioscience, Inc. completed OPUS-1, a Phase 3 study of lifitegrast ophthalmic solution for the treatment of dry eye disease (November 2012).

• Avedro, Inc. and EyeGate Pharma announced that Avedro will hold an exclusive license to EyeGate Pharma's iontophoresis patents in the field of corneal collagen cross-linking (October 2012).

• Nicox S.A. announced its launch in the United States of AdenoPlus™, a rapid point-of-care diagnostic test that detects of adenovirus in ocular samples from patients with conjunctivitis (October 2012).

• GlaxoSmithKline announced plans to create a system that will enable researchers to access the detailed anonymized patient-level data that sit behind the results of clinical trials of its approved medicines and discontinued investigational medicines. They also announced they will publish results of screening data of its library of more than 2 million compounds for any that may inhibit tuberculosis bacteria (October 2012).

• Roche has taken a lead role in rallying 9 other large pharmaceutical firms to build a major collection of 1,500 induced pluripotent stem cell lines for use in early testing of drugs against a range of neurological ailments as well as diabetes (December 2012).

• Swissmedic, Switzerland's health regulator, imposed an immediate ban on Novartis AG's flu vaccines after possibly contaminated flu shots were found in batches in Italy (October 2012).

• The European Union approved for sale the Western world's first gene-therapy drug from UniQure for the treatment of lipoprotein lipase deficiency (November 2012).

• Two additional products from New England Compounding Center—preservative free betamethasone and cardioplegia solution—have tested positive for bacterial contamination, consistent with the finding of fungal contamination of its methylprednisolone acetate (October 2012).

• A Tennessee cancer doctor has pleaded guilty to purchasing illegal foreign drugs, as part of a long-running investigation into overseas distributors that sold fake versions of the cancer drug Avastin^® (bevacizumzab) and other unapproved medicines to U.S. clinics (November 2012).