FDA Approves Mitosol® for Immediate Production and Use in Glaucoma Surgery

 

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.

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.

CONTACT:
Jim Anderson
Mobius Therapeutics, LLC
314-615-6930
Jim.Anderson@mobiustherapeutics.com

Andy Likes
The Vandiver Group, Inc.
314-991-4641
alikes@vandivergroup.com

SOURCE Mobius Therapeutics, LLC

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