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FDA grants final approval for glaucoma drug platform

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ST. LOUIS — The U.S. Food and Drug Administration has granted final approval for the Mitosol platform product for use in glaucoma surgery, according to Mobius Therapeutics. The company will begin producing and marketing the system immediately, a press release said.

"The approval of Mitosol for use in glaucoma surgery represents the culmination of more than 5 years of work on the part of Mobius Therapeutics," Ed Timm, president of Mobius Therapeutics, said in the release. "It will provide surgeons, hospitals and patients with enhanced convenience, safety and consistency in the surgical treatment of glaucoma."

The Mitosol system allows ophthalmic surgeons to deliver a precise dose of its active ingredient, mitomycin C, without any change to their technique, the release said.

The FDA granted orphan drug designation for Mitosol to prevent the recurrence of pterygium after surgical excision in January 2011.