
Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Aerie Pharmaceuticals, Inc. has resubmitted its NDA (New Drug Application) for RhopressaTM to the FDA after notification by its contract drug product manufacturer that the vendor’s Tampa, Florida facility is now ready for pre-approval inspection by the FDA for Rhopressa. As background, the Rhopressa NDA was withdrawn in October 2016 due to the contract manufacturer not yet being prepared for pre-approval inspection by the FDA at that time.
- Valeant Pharmaceuticals International, Inc.’s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. today announced the resubmission of an NDA to the U.S. FDA seeking approval for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension.
- Clearside Biomedical, Inc. announced it has initiated a strategic realignment of its research and development resources from its pre-clinical development program for axitinib for the treatment of wet age-related macular degeneration (AMD) toward its ongoing clinical development program for the treatment of diabetic macular edema assessing ZuprataTM, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide. Additionally, the company reported it had received its ninth U.S. Patent, entitled "Methods and Devices for the Treatment of Ocular Diseases in Human Subjects."
- BioLight Life Sciences Ltd. announced its subsidiary, DiagnosTear Ltd., has signed a services agreement with a pharmaceuticals company where it will provide analysis services through its TeaRx™ multi-parameter diagnostic assays for use in a clinical trial for dry eye syndrome. This will reportedly be the first time that TeaRx will be used in a drug trial.
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