Eyes on New Product Development

Abstract

In this reporting period, in cornea, one firm gained approval for a new therapy for the treatment of neurotrophic keratitis, another completed enrollment of a Phase 2 study evaluating a novel dry eye therapy, and a third is developing a treatment for endothelial cell-mediated diseases. In genetic retinal degeneration, a gene therapy product is in late-stage review by the U.S. FDA, and another firm received orphan designation for a single-stranded RNA oligonucleotide. In fixed-dose combinations for glaucoma, two firms announced results of clinical trials. In uveitis, one firm started a Phase 2 study, and another expanded its market potential. The U.S. FDA extended the shelf life of several sterile injectable products, based upon shortages.

Ophthalmic Pharmaceuticals and Biologics

• Aerie Pharmaceuticals reported the successful 12-month safety results of its “Mercury 1” study of its fixed-dose combination of netarsudil and latanoprost (Roclatan™) in the treatment of glaucoma (July 2017).

• Aldeyra Therapeutics completed dosing in its Phase 2a clinical trial of ADX-102 in patients with dry eye disease (July 2017).

• Alimera Sciences secured the rights to pursue treatment of posterior uveitis with its Iluvien^® triamcinolone acetonide intravitreal implant from pSivida (July 2017).

• Dompe received marketing authorization from the European Commission for its cenegermin eye drops (a recombinant version of human nerve growth factor) for the treatment of neurotrophic keratitis (July 2017).

• Galapagos, through its partner Gilead, commenced a Phase 2 study of filgotinib for the treatment of noninfectious uveitis (July 2017).

• Inotek announced results of a Phase 2 study of a fixed-dose combination of trabodenoson and latanoprost for the treatment of glaucoma (July 2017).

• Lupin Limited launched of its generic moxifloxacin HCl ophthalmic solution in the United States (July 2017).

• Ocular Therapeutix received a second complete response letter from the U.S. FDA for its New Drug Application for Dextenza™, its dexamethasone intracanicular implant for the treatment of postoperative inflammation (July 2017).

• ProQR received orphan drug designation from the U.S. FDA for its QRX-411, a single-stranded RNA oligonucleotide which targets the pseudo-exon 40 mutation in the USH2A gene, for the treatment of retinitis pigmentosa (July 2017).

• Spark Therapeutics' voretigene neparvovec (Luxturna™) Biologics License Application was accepted for review by the U.S. FDA. It also received a rare pediatric disease designation from U.S. FDA (July 2017).

• Trefoil Therapeutics announced that its first development product is TTHX1114, an engineered fibroblast growth factor 1 (FGF-1) compound to treat endothelial cell-mediated diseases, including Fuchs dystrophy (March 2017).

Regulatory, Government, and Pharmaceutical Industry

• The Association for Accessible Medicine (a generic manufacturer's trade group) filed a suit against the state of Maryland with regard to their new law aimed at curbing price increases for generic drugs (July 2017).

• The U.S. FDA announced adverse events of ocular toxicities (including vision loss and retinal detachment) for the oncology therapeutics Keytruda^® (pembrolizumab), Opdivo^® (nivolumab), and Yervoy^® (ipilimumab) (July 2017).

• The U.S. FDA extended the shelf life for several injectable products, including sodium bicarbonate and atropine sulfate, based upon ongoing critical shortages (July 2017).

Footnotes

Author Disclosure Statement

The author consults numerous ophthalmic pharmaceutical and medical device firms.