Eyes on New Product Development

Adverum Biotechnologies has an active investigational new drug exemption for its planned phase 1 study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration (August 2018).

Aerie announced results from an aqueous humor dynamic study of Rhopress^® (netarsudil) in patients with open-angle glaucoma or ocular hypertension (August 2018).

Allergan is working with the genome editing company Editas Medicine to develop and commercialize EDIT-101 CRISPR genome editing medicine for the treatment of Leber congenital amaurosis type 10 (August 2018).

Amicus Therapeutics received U.S. FDA approval for its Galafold™ (migalastat) for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data. This approval used the accelerated approval pathway and was granted priority review (August 2018).

Aura Biosciences presented data from a phase 1b/2 clinical trial of AU-011, a light-activated vision-sparing tumor cell selective therapy for patients with choroidal melanoma (August 2018).

Dompe received U.S. FDA approval for its Oxervate™ (cenegermin-bkbj), a recombinant human nerve growth factor, indicating for the treatment of neurotrophic keratits (August 2018).

EyeGate Pharmaceutical announced top-line results from its phase 3 study, evaluating the safety and efficacy of EGP-437 (dexamethasone) delivered through its drug delivery system in the treatment of patients with noninfectious anterior segment uveitis (September 2018).

Eyenovia reported results of its PG21 study, evaluating a microdose of piezo-print latanoprost in volunteers (August 2018).

Glaukos entered into a research and development collaboration agreement with D. Western Therapeutics Institute (DWTI) for joint research development of novel intraocular products for the treatment of glaucoma using compounds from DWTI's proprietary rho kinase (ROCK) inhibitor compound library (August 2018).

Imprimis Pharmaceuticals is conducting a study of its triamcinolone acetonide-moxifloxacin intraocular injection in Canada (August 2018).

Kala Pharmaceuticals received U.S. FDA approval for its Inveltys™ (loteprednol etabonate ophthalmic suspension) for the treatment of postoperative inflammation and pain after ocular surgery (August 2018).

Nicox started enrollment in a phase 2 study of NCX 470, a nitric oxide-donating prostaglandin analogue, for the reduction of intraocular pressure (IOP) (August 2018).

Novartis received approval from the European Commission for its Kymriah CAR-T Cell Therapy for the treatment of pediatric and young adult patients with selected leukemia and lymphomas (August 2018).

Omeros announced that a patent infringement lawsuit with Sandoz regarding generic Omidria^® (phenylephrine and ketorolac intraocular solution) has been dismissed (August 2018).

Polyactiva is conducting clinical trials of an implantable delivery system for the treatment of elevated IOP (August 2018).

ProQR Therapeutics announced results from a planned interim analysis of its phase 1/2 trial of QR-110 in patients with Leber's congenital amaurosis 10 due to the p.Cys998X mutation in the CEP290 gene (September 2018).

Regeneron received U.S. FDA approval for its Eylea^® (aflibercept) on a 12-week dosing schedule for the treatment of wet age-related macular degeneration (August 2018).

RXi Pharmaceuticals announced results of a phase 1/2 clinical trial, RXI-109-1501, an open-label multidose escalation study with 3 dose cohorts, enrolled sequentially, evaluating the safety and tolerability of RXI-109, an RNAi therapy, injections in the eye of subjects with advanced neovascular age-related macular degeneration (August 2018).

Sun Pharma received approval from the U.S. FDA for its Cequa^® (cyclosporine ophthalmic solution) 0.09% to increase tear production in patients with keratoconjunctivitis sicca (August 2018).

Tetra Bio-Pharma submitted orphan drug applications to the U.S. FDA for cannabinoid treatment of rare cancers and ocular diseases (August 2018).

Tetraphase Pharmaceuticals received U.S. FDA approval for its Xerava™ (eravacycline) for intravenous injection. The indication for this new chemical entity antibiotic is for the treatment of complicated intraabdominal infections. This new drug provides a new option to combat the growing threat from treatment-resistant bacteria (August 2018).

Teva received approval from the U.S. FDA for a generic version of EpiPen (epinephrine, August 2018).

Yuyu Pharmaceuticals received approval from the Korean Ministry of Food and Drug Safety to go ahead with domestic phase 1 clinical trials for YY-101, a peptide-based dry eye treatment (March 2018).

EyeGate Pharmaceuticals began enrollment in a randomized study evaluating the ability of its Ocular Bandage Gel to reduce corneal staining in patients with punctate epitheliopathies due to pathologies such as dry eye (August 2018).

Ivantis received U.S. FDA approval for its Hydrus Microstent for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma (August 2018).

Retina Implant's Alpha AMS subretinal device will be evaluated in blind patients with retinitis pigmentosa (August 2018).

The U.S. FDA issued a draft guidance for human gene therapy for retinal disorders (July 2018).