Eyes on New Product Development

Abstract

In this reporting period, phase 1 trials with a new formulation, possibly useful in dry eye, were announced, as was the completion of a second efficacy study on a novel molecule with a possible new mechanism of action. In glaucoma, phase 3 results were announced for a new molecule. A phase 3 trial of another new formulation, potentially improving bioavailability, was announced for an ophthalmic corticosteroid. Retina continues to be an area of activity, ranging from preclinical gene therapy studies to an early-stage trial of a cell therapy, as well as one on a novel treatment for geographic atrophy, to approvals in various countries for a number of indications. Several business deals were announced in this period dealing with refractive and anterior segment therapies. Finally, in response to the Ebola virus crises, the U.S. Food and Drug Administration (FDA) has allowed a novel therapy to enter investigational clinical trials.

Ophthalmic Pharmaceuticals

• Advanced Cell Technology has completed enrollment in a phase 1 trial of retinal pigment epithelial cells in Stargardt's macular degeneration (September 2014).

• Alimera Sciences, Inc. received U.S. FDA approval for ILUVIEN^® (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME) in patients who have previously been treated with a course of corticosteroids and did not have a clinically significant increase in intraocular pressure (September 2014). Alimera also received approval for ILUVEIN^® in an additional 10 European Union countries (June 2014).

• Allergan received European Union approval for Ozurdex^® (dexamethasone intravitreal implant) for the treatment of DME (September 2014).

• Bausch+Lomb has completed a phase 3 trial of a submicron formulation of loteprednol etabonate gel (September 2014). Bausch+Lomb also presented results from its phase 3 studies of Vesneo^® (latanoprostene bunod), initially from Nicox, in the treatment of elevated intraocular pressure in patients with glaucoma and ocular hypertension (September 2014).

• Genzyme announced a collaboration with the University of Florida and University of Pennsylvania to develop a gene therapy for Leber congenital amaurosis (September 2014).

• Mimetogen announced results for a second clinical study with MIM-D3 for the treatment of dry eye (September 2014).

• Novaliq has completed two phase 1 studies: one with its semifluorinated alkane vehicle, F4H5 with cyclosporine, and the other with NovaTears^® over the counter (September 2014).

• Regeneron received U.S. FDA designation for breakthrough therapy for Eylea^® (aflibercept) for the treatment of diabetic retinopathy in patients with DME (September 2014).

• Roche is starting a clinical trial of lampalizumab for the treatment of geographic atrophy (September 2014).

• ThromboGenics received approval for JETREA^® (ocriplasmin) in South Korea (September 2014).

Regulatory, Government, and Pharmaceutical Industry

• Avedro acquired the assets of IROC Innocross, including a cross-linking device used to treat corneal abnormalities (September 2014).

• Nicox acquired Carragelose^®, an antiviral eye drop, from Marinomed Biotechnologie. Nicox acquired Doliage, a French ophthalmic firm (September 2014).

• Nitto Medic will distribute AdenoPlus^®, a diagnostic test for adenovirus in Japan under an arrangement with Nicox (August 2014).

• Tekmira was allowed by the U.S. FDA to provide its experimental drug, TKM-Ebola, to patients with Ebola viral infection (September 2014).

Footnotes

Author Disclosure Statement

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