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    Novel therapies abound in pipeline

    What clinicians should know about drugs, biologics in development for various diseases

    The importance of novel therapies for ocular disease is a given. However, as most novel therapies are financed by the private sector, it is fortunate that investors find ophthalmology a worthwhile investment.1

    This article provides an overview of new therapies—focusing on U.S. development, while also noting some products from outside the United States.

    In 2016, six ophthalmic products with New Drug Applications (NDAs) under consideration at the FDA were not approved based upon matters related to the chemistry, manufacture, and control (CMC). These products included:

    • A multi-dose, non-preserved formulation cyclosporine ophthalmic emulsion for dry eye disease (Restasis, Allergan);
    • A dexamethasone intracanalicular implant for inflammation (Dextenza, Ocular Therapeutix);
    • Latanoprostene bunod for glaucoma (Vyzulta,  Bausch + Lomb/Nicox);
    • Netarsudil for glaucoma (Rhopressa, Aerie Pharmaceuticals);
    • AC-170 (cetirizine) for allergic conjunctivitis (Zerviate, Nicox), and
    • A swollen nanocellular microemulsion latanoprost for glaucoma (Sun Pharmaceutical).2


    Two products—cyclosporine and cetirizine—were approved this year. The remaining four NDAs are still under consideration.

    Recent U.S. approvals, in chronological order starting in early 2016, include:

    • A local anesthetic, tetracaine (previously an “unapproved” therapy);3
    • A new formulation of the non-steroidal, anti-inflammatory agent, bromfenac (BromSite, Sun Ophthalmics);
    • The combination product of riboflavin/ultraviolet radiation for corneal pathology (Photrexa, Avedro);
    • An LFA-antagonist for dry eye disease (lifitegrast; Xiidra, Shire), and
    • A new antihistamine, cetirizine (Zerviate) for allergic conjunctivitis, as noted above.

    Also approved were additional indications for adalimumab for uveitis (Humira, AbbVie); giant cell arteritis for tocilizumab (Actemra, Genentech); additional diabetic retinopathy indications for ranibizumab (Lucentis, Genentech), and as aforementioned, a multidose, non-preserved formulation of cyclosporine (Restasis).

    Based upon publicly available information, seven ophthalmic NDAs or Biological License Applications are under FDA review. Some were noted above, as they were initially submitted in 2016. They include: brimonidine 0.025% (redness); dexamethasone insert for intracanalicular use; latanoprostene bunod 0.24%; netarsudil 0.02%; sirolimus 440 μg; an intracameral dexamethasone, and the first ophthalmic gene therapy under review, voretigene neparvovec.

    Phase III

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