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FDA Approves Mitosol

Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol

ST. LOUIS, Feb. 9, 2012 /PRNewswire/ -- Mobius Therapeutics, LLC, a St. Louis-based ophthalmic company, has received final approval from the U.S. Food and Drug Administration for the platform product, Mitosol. This initial indication is for the use of Mitosol in glaucoma surgery. With FDA approval, Mobius Therapeutics can start marketing and production efforts for Mitosol immediately.

"The approval of Mitosol for use in glaucoma surgery represents the culmination of more than five years of work on the part of Mobius Therapeutics," said Ed Timm, President of Mobius Therapeutics. "It will provide surgeons, hospitals, and patients with enhanced convenience, safety, and consistency in the surgical treatment of glaucoma."

Glaucoma is the second-leading cause of blindness in the United States. It is treated progressively, beginning with pharmaceuticals, then office intervention and finally surgery. Mitosol provides a new system for delivering a precise dose of its active ingredient, mitomycin-c, to ophthalmic surgeons for use in procedures without any change to their current technique.

"The approval of Mitosol is an important event on multiple levels", stated Dr. Henry D. Jampel, Odd Fellows and Rebekahs Professor of Ophthalmology at the Wilmer Eye Institute of Johns Hopkins University. "Surgeons, patients and operating room staff will benefit from improved precision, convenience, quality assurance, and safety."

Mobius manufactures Mitosol locally, using St. Louis-based sterile packaging, precision medical molding, commercial sterilization and pharmaceutical logistic firms.

"We believe that Mobius represents a new and efficient model for merging a company's strengths with the locally available resources," said St. Louis Mayor Francis Slay. "As part of the local life science community, Mobius' approval represents a win not only for the company, but for the St. Louis economy as a whole."

About Mobius Therapeutics, LLC:

Mobius Therapeutics is an early stage venture focused on ophthalmic surgery solutions. Its first product, Mitosol, is a system for delivering antifibrotic agents in glaucoma, refractive, and corneal surgery. The glaucoma indication is in active commercialization; the refractive and corneal indications are awaiting approval by the Food and Drug Administration.

Jim Anderson
Mobius Therapeutics, LLC

Andy Likes
The Vandiver Group, Inc.

SOURCE Mobius Therapeutics, LLC

Posted: February 2012

Mitosol (mitomycin) FDA Approval History

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