Mitosol gains refractive indication

June 22, 2011

A preparation of ophthalmic mitomycin (Mitosol, Mobius Therapeutics) has received a third orphan drug designation from the FDA. This indication is for use in preventing corneal haze following surface ablation laser keratectomy, and adds a refractive indication to two previous orphan drug designations for the product: glaucoma and pterygium.

St. Louis-A preparation of ophthalmic mitomycin (Mitosol, Mobius Therapeutics) has received a third orphan drug designation from the FDA. This indication is for use in preventing corneal haze following surface ablation laser keratectomy and adds a refractive indication to two previous orphan drug designations for the product: glaucoma and pterygium.

“This final designation of [ophthalmic mitomycin] allows us to realize the full strategic vision of Mobius Therapeutics,” said Ed Timm, president of Mobius Therapeutics. “We will enter the market with a platform product that allows us to access every glaucoma surgeon and site of service worldwide. We will also offer an exclusive, annuity product in refractive surgery and ocular surface surgery. This will be done with a single product that offers precision, convenience, and quality assurance.”