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news.Ista Pharmaceuticals has filed an investigational new drug application with the FDA to initiate a phase III study of a new tobramycin and prednisolone acetate combination product for inflammatory ocular conditions.
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The ophthalmic product will be developed for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.
The product is a fixed combination of tobramycin and prednisolone acetate, both already approved drugs on their own, in a proprietary formulation that Ista believes will be more comfortable for patients with inflamed eyes.
If approved, the product will compete in the antibiotic steroid segment of the US topical ophthalmic anti-inflammatory market.
If the phase III trial program goes to plan, Ista expects to be able to file a new drug application (NDA) with the FDA during the first half of next year.