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Biopharmaceuticals Ophthalmology FDA

 News Release - October 31, 2017

Mitosol(R)'s Orphan Drug Designation is Expanded for All Glaucoma Surgery

St. Louis ophthalmic company expands designation to include all glaucoma surgery

ST. LOUIS, Oct. 31, 2017 -- (Healthcare Sales & Marketing Network) -- Mobius Therapeutics™, 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.

XEN® is a registered trademark of Allergan, Inc.


Source: Mobius Therapeutics

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