pSivida Submits New Drug Application (NDA) for Durasert™ Three-Year Treatment for Posterior Segment Uveitis to the U.S. FDA
PSIVIDA (PSDV)
Last psivida earnings: 2/7 04:02 pm
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Source: GlobeNewswire
WATERTOWN, Mass., Jan. 08, 2018 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Durasert three-year treatment for posterior segment uveitis. The NDA includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months with a p value “We have previously developed and out-licensed three sustained-release treatments for other back-of-the-eye diseases, all of which received FDA approval. This positive track record is an asset as we enter this next phase of development for our company’s first commercial product,” commented Nancy Lurker, President and CEO. “Durasert is our lead product candidate for the treatment for posterior segment uveitis, the third leading cause of blindness. Our goal with Durasert is to provide relief to the thou
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