By expanding this orphan drug indication, Mobius Therapeutics may now assume the benefits of orphan drug designation for new and evolving MIGS procedures used in the treatment of glaucoma.
ST. LOUIS, October 31, 2017 (Newswire.com) - Mobius Theraputics™, LLC, a St. Louis-based ophthalmic company, has expanded its Orphan Drug Designation from the Food and Drug Administration for its platform product, Mitosol®, to now read “Treatment of refractory glaucoma as an adjunct to surgery.”
By expanding this orphan drug indication, Mobius Therapeutics™ may now assume the benefits of orphan drug designation for new and evolving MIGS procedures used in the treatment of glaucoma.
“This expanded designation offers the benefits of Mitosol® in new and evolving procedures employing an ab interno approach, versus traditional ab externo approaches,” said Ed Timm, president of Mobius Therapeutics™. “New MIGS procedures, typified by the XEN® Gel Stent, have relied upon Mitosol® as a companion drug during pivotal clinical trials. Going forward, we may now pursue these indications, assuring these patients and providers that the precision, safety and unprecedented convenience of Mitosol® will be available to all.”
About Mobius Therapeutics, LLC:
Mobius Therapeutics™ is a commercial stage venture focused upon perioperative sterile injectables used in ophthalmic surgery. Its first product, Mitosol®, is the only FDA approved formulation of mitomycin-c bearing an ophthalmic indication. Mobius maintains an active sterile injectable product pipeline in varying stages of development. Please see full prescribing information at www.Mitosol.com and www.EyeAmphadase.com.
