Orphan Drug Designation Expanded for Mobius Therapeutics’ Mitosol

November 3, 2017: By Jon Swedien

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Mobius Therapeutics announced Oct. 31 that the orphan drug designation for Mitosol has been changed to read: “treatment of refractory glaucoma as an adjunct to surgery.”

Mitosol is an ophthalmic reformulation of mitomycin C for use in glaucoma surgery. The new designation lays the groundwork for Mobius to pursue an expanded indication for Mitosol that would include refractory glaucoma surgery.

The new designation qualifies Mobius for a research and development tax credit and a waiver of its prescription drug user fee when it seeks an expanded designation, said Ed Timm, president of Mobius.

Ultimately, Mobius would like to pursue an expanded indication for Mitosol that would cover ab interno glaucoma surgery, Timm said. Ab interno glaucoma surgery includes minimally invasive glaucoma surgeries (MIGS). Mitosol is currently indicated as an adjunct to ab externo glaucoma surgery.

“New MIGS procedures, typified by the XEN Gel Stent, have relied upon Mitosol as a companion drug during pivotal clinical trials,” Timm said.

InnFocus, now part of Santen, has also used Mitosol in clinical trials for its MicroShunt MIGS device, Timm said.

St. Louis-based Mobius is a commercial stage venture focused upon perioperative sterile injectables used in ophthalmic surgery.

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