pSivida On Cusp Of Uveitis Filings As EU Licensing Deal Nears
Phase III data from a second study support the three-year therapy Durasert in posterior uveitis, paving the way for EU and US filings.
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Yutiq, for posterior uveitis, will compete with two existing steroid products and should launch during the first quarter of 2019. EyePoint’s Dexycu, although approved in February, is still in scale-up and probably will launch a bit later.
The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.
The two companies can now market their HER-2 targeting antibody-drug conjugate in its second tumor type as they look to expand beyond breast cancer.