Mitomycin C system designated orphan drug for pterygium

St. Louis, MO-An ophthalmic mitomycin C system (Mitosol, Mobius Therapeutics) used in the prevention of recurrence of pterygium after its surgical excision has received orphan drug designation from the FDA, according to the company.

The product provides for extended, on-site, room-temperature storage of ophthalmic mitomycin-C. With a closed handling system, it is designed to permit safe and efficient delivery of a precise, single dose of ophthalmic mitomycin C.

“The designation of [the system] 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,” said Ed Timm, president of the company.

Orphan drug designation is granted specifically to treat rare medical diseases or conditions. “Removal of pterygium is a specialized indication for the use of [the product] in ophthalmology, precisely the type of application to be protected by orphan drug status,” said Timm.

The system is awaiting regulatory approval, and additional applications are in the early stages of development.