Eyes on New Product Development

Abstract

In the recent period, there was substantial activity in the treatment of dry eye (patents issued, filing of a generic cyclosporine, an unsuccessful efficacy trial, a new Phase 3 trial, and cessation of U.S. development of a molecule). There is continued development of agents for the treatment of inflammation and retinal degeneration, and novel diagnostics. Advanced development and regulatory discussions continue on the therapeutics for retinal disease, and a hydrogel-based sealant was approved in the United States. Firms executed several arrangements to market products for glaucoma, retina, and infection.

Ophthalmic Pharmaceuticals

• Actavis's subsidiary, Watson Laboratories, Inc., has submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Allergan, Inc.'s Restasis^® (cyclosporine ophthalmic emulsion, January 2014).

• Acucela announced it is no longer pursuing rebamipide as a treatment for dry eye in the United States (December 2013).

• Alimera Sciences announced that it has entered into labeling discussions with the U.S. FDA for ILUVIEN^® (fluocinolone acetonide intravitreal implant, December 2013). In addition, the United Kingdom's National Institute for Health and Care Excellence (NICE) published final guidance for ILUVIEN (December 2013). Also, Alimera Sciences announced that the Scottish Medicines Consortium has accepted ILUVIEN (fluocinolone acetonide intravitreal implant) for restricted use within the National Health Service (NHS) Scotland for the treatment of diabetic macular edema in pseudophakic patients insufficiently responsive to available therapies (February 2014).

• Allergan obtained new patents that may extend the U.S. exclusivity for Restasis (cyclosporine ophthalmic emulsion) (December 2013).

• Bioheart announced that it will enroll patients in a study of efficacy of adipose-derived stem cells in patients with dry macular degeneration (December 2013).

• Can-Fite's OphthaliX subsidiary completed analysis of a Phase 3 study of oral CF101 for the treatment of dry eye syndrome (December 2013). Can-Fite was granted a U.S. patent for utilization of the A3 adenosine receptor as a biomarker to predict the patient's response to CF101 in autoimmune inflammatory indications (December 2013).

• Cell Cure, a subsidiary of BioTime is developing OpRegen^®, a cell-based therapeutic product, for age-related macular degeneration (December 2013).

• Eleven Biotherapeutics has initiated a Phase 3 clinical study (OASIS) of EBI-005, a topically administered interleukin-1 (IL-1) receptor blocker in dry eye disease (February 2014).

• InSite Vision completed dosing and evaluation in the confirmatory Phase 3 clinical trial of BromSite™ (0.075% bromfenac in DuraSite^®, ISV-303) for the reduction of inflammation and pain after cataract surgery (November 2013).

• Kala Pharmaceuticals submitted an Investigational New Drug (IND) application to the U.S. FDA to initiate a Phase 3 clinical program with its loteprednol etabonate ophthalmic nanosuspension product for the treatment of postoperative inflammation and pain following cataract surgery (January 2014).

• QLT, Inc. announced that the first patient has been dosed in the company's Phase IIa proof-of-concept trial of QLT091001 in adult subjects with impaired dark adaptation (December 2013).

• Regeneron Pharmaceuticals completed analysis of a study of Eylea^® (aflibercept) in the VIBRANT study in patients with macular edema following branch retinal vein occlusion (October 2013). The firm also completed an analysis of 2-year results from the VISTA trial of Eylea (aflibercept) for the treatment of diabetic macular edema (February 2014).

• The German Institute for Quality and Efficiency in Health Care (IQWiG) said it was unable to assess whether its new eye medication Eylea (aflibercept) offered an advantage over Lucentis^® (ranibizumab, January 2014).

• Stelis Biopharma and Pieris AG announced initiation of a collaboration for clinical development and commercialization of multiple novel Anticalin^®-based protein therapeutics worldwide, primarily focusing on ophthalmology (December 2013).

Other Ophthalmic Products

• Ocular Therapeutix received approval from the FDA to commercialize the ReSure^® Sealant, a polyethylene glycol-based hydrogel, in the United States, with an indication for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery (January 2014).

• The Massachusetts Eye and Ear/Harvard Medical School Department of Ophthalmology announced the availability of a comprehensive genetic diagnostic test for inherited eye diseases (November 2013).

Regulatory, Government, and Pharmaceutical Industry

• Akorn acquired the rights to 3 branded products from Merck AzaSite^® (azithromycin ophthalmic suspension), Cosopt^® (dorzolamide HCl/timolol maleate ophthalmic solution), and Cosopt-PF (preservative free, November 2013). In addition, Akorn has acquired rights to Betimol^® (timolol hemihydrate ophthalmic solution) from Santen (January 2014).

• Biocon Ltd, and Quark Pharmaceuticals, Inc. entered into a pact for developing a range of siRNA-based novel therapeutics, which will allow Biocon to codevelop, manufacture, and commercialize QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets (December 2013).

• GlaxoSmithKline said it would stop paying doctors to attend medical meetings or to speak about its drugs and the diseases treated by its medicines (December 2013).

• Nicox acquired Eupharmed, an Italian pharmaceutical firm (November 2013).

• Voyant Biotherapeutics, a company formed out of its Center for Translational Medicine at University of Utah, has signed an exclusive R&D Collaboration Agreement with Allergan, with a primary effort on treatment of age-related macular degeneration (February 2014).

Footnotes

Author Disclosure Statement

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