Mobius Therapeutics has expanded its orphan drug designation from the FDA 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," Ed Timm, president of Mobius Therapeutics, said in a company news release. "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."