Clearside Biomedical predicts its uveitis drug will be rejected, after FDA requests more data
In its second-quarter update earlier this month, eye drug developer Clearside Biomedical indicated it was looking to out-license its lead drug, Xipere, which is currently under FDA review. But those plans may be put on hold after the company on Thursday disclosed the FDA has asked for more data on the drug’s marketing application.
As a result, Clearside expects to receive a Complete Response Letter from the FDA on or before the decision date of October 19, it said. The drug, Xipere (triamcinolone acetonide ophthalmic suspension), is being evaluated for the treatment of macular edema associated with uveitis, which is characterized by inflammation of the middle layer of the eye.
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