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news.The Food and Drug Administration (FDA) has granted orphan drug status (ODD) for Mobius Therapeutics' Mitosol, intended for preventing corneal haze following surface ablation laser keratectomy.
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With the current status Mitosol now has three ODDs for glaucoma, pterygium, and refractive indications.
Mobius president Ed Timm said this designation of Mitosol as an orphan drug will help Mobius Therapeutics provide surgeons and patients with enhanced convenience, safety, and consistency following surface ablation procedures.
"We will enter the market with a platform product that allows us to access every glaucoma surgeon and site of service worldwide," Timm said.
"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."