Eyes on New Product Development

Abstract

In the recent period, for dry eye, a small firm completed a Phase 1b/2a study for a novel biologic in dry eye, and a large firm acquired an option for a small molecule also in Phase 2. In the retina, a diabetic macular edema treatment study was finished, and a new indication was approved for a biologic as well as continued activity in the clinical development of a corticosteroid implant treatment for uveitis. Additional business arrangements were made in glaucoma therapy, a femtosecond laser, and the patent activity was seen in drug delivery. The U.S. Food and Drug Administration (FDA) was active in generic drugs with a draft guidance for a dry eye treatment and a proposed change in labels for generic products.

Ophthalmic Pharmaceuticals

• Acadia Pharmaceuticals, Inc., announced that Allergan, Inc., has advanced an additional small molecule, collaborative product candidate as a potential new treatment for glaucoma (June 2013).

• Bausch+Lomb has acquired an option to license Mimetogen Pharmaceuticals, Inc., for the compound, MIM-D3, currently in Phase 2, for the treatment of dry eye (July 2013).

• Eleven Biotherapeutics completed the analysis of a Phase 1b/2a study of EBI-005, a Topical IL-1 Inhibitor Protein Therapeutic, in patients with dry eye disease (June 2013).

• iCo Therapeutics, Inc., announced that it 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).

• InSite Vision, Inc., has regained North American development rights to azithromycin ophthalmic solution 2% (AzaSite Xtra™) from Inspire Pharmaceuticals, Inc. (June 2013).

• InSite Vision, Inc., announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on its DuraSite^® 2, an enhanced drug delivery system (July 2013).

• Novartis announced that ranibizumab was approved by the European Commission for the treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia (July 2013).

• pSivida Corp has completed an investigator-sponsored Phase I/II study of its fluocinolone acetonide injectable microinsert in patients with posterior uveitis. They have also initiated the first of the two planned pivotal Phase III trials in the same indication (July 2013).

Other Ophthalmic Products

• Abbott has entered into an agreement to purchase OptiMedica Corporation, the manufacturer of a femtosecond laser (July 2013).

• Retina Implant AG, announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark in Europe (July 2013).

Regulatory, Government, and Pharmaceutical Industry

• The U.S. FDA Office of Generic Drugs (OGD) proposed draft guidelines for a generic version of Restasis^® (cyclosporine ophthalmic emulsion) that allow for either an in vitro analytical assay or a clinical efficacy study. Allergan, the manufacturer of Restasis, has announced that they will challenge this draft guidance (June and July 2013).

• The U.S. FDA is planning a proposed rule that would allow generic drug companies to update prescribing information for their products to reflect new safety information from the branded product. This is in contrast to current regulations (July 2013).

Footnotes

Author Disclosure Statement

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