Mobius Therapeutics, an ophthalmic company, has begun commercial shipments of Mitosol (mitomycin for solution) kit for ophthalmic use.
Mitosol will provide a new system for delivering a precise dose of its active ingredient, mitomycin-c, for use by ophthalmic surgeons in procedures without any change to its current technique.
Mobius Therapeutics president Ed Timm said the FDA approval of Mitosol for use in glaucoma surgery was the culmination of six years of collaborative work with the FDA and clinicians.
"Now that we have sufficient inventory on hand and manufacturing optimized, we can begin providing surgeons, hospitals, and patients an uninterrupted source of supply of this important agent used in the surgical treatment of glaucoma," Timm added.
According to the company, Mitosol is the first and only formulation of mitomycin-c, specifically approved for an ophthalmic indication.
Mitosol is a system for delivering antifibrotic agents in glaucoma, refractive, and corneal surgery. The glaucoma indication is in active commercialization while the refractive and corneal indications are awaiting approval by the FDA.