WATERTOWN, Mass., June 22, 2017 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market the Company's Durasert three-year treatment for posterior segment uveitis in the European Union (EU).

"Our MAA submission is another significant milestone delivered on time by the pSivida team," commented Nancy Lurker, President and Chief Executive Officer. "Durasert three-year uveitis treatment, our lead product candidate, has now proven to be highly effective in reducing the recurrence of uveitis in two Phase 3 studies.  Both studies illustrate the benefits Durasert brings to those patients suffering from this disease, which is a leading cause of blindness.  As we await the review from the EU regulators, we continue to have advanced discussions with potential partners and are focused on entering into an out-licensing agreement for Durasert in the EU sometime this summer."

In each of pSivida's two Phase 3 trials for its Durasert three-year uveitis treatment, the primary efficacy endpoint was successfully achieved at six months with a p value <0.001. In addition, the safety profile of patients treated with Durasert three-year uveitis treatment was comparable to the safety profile of existing steroid uveitis treatments, which are considered standard of care for this disease.

Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is believed to be a leading cause of blindness in the developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S. and EU, posterior uveitis affects ~200,000 people, annually. Today, patients with posterior uveitis are typically treated with systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.

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