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Mobius Therapeutics receives orphan drug designation for system to halt pterygium recurrence
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ST. LOUIS —The U.S. Food and Drug Administration has granted Mobius Therapeutics orphan drug designation for a system used to prevent the recurrence of pterygium after surgical excision, the company announced in a press release.
The Mitosol system provides for the extended storage of mitomycin C. Combined with a closed handling system, it can deliver a single dose of mitomycin to stop the recurrence of pterygium and similar visual obstructions after surgical removal, according to company literature. The system has also demonstrated efficacious action in glaucoma, as well as corneal and refractive surgery.
"The designation of Mitosol as an orphan drug will help Mobius Therapeutics provide surgeons and allied health personnel with improved convenience, safety and precision in their treatment of pterygium," Ed Timm, president of Mobius Therapeutics, said in the release.
The Mitosol system, which is also being developed in additional indications, is awaiting regulatory approval.