pSivida Submits Marketing Authorization Application for Approval of Durasert 3-Year Treatment for Posterior Segment Uveitis in the EU

Source: pSivida

pSivida Corp. has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market the company’s Durasert 3-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,” Nancy Lurker, President and Chief Executive Officer, said in a company news release. “Durasert 3-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 3-year uveitis treatment, the primary efficacy endpoint was successfully achieved at 6 months with a P value <0.001. In addition, the safety profile of patients treated with Durasert 3-year uveitis treatment was comparable to the safety profile of existing steroid uveitis treatments, which are considered standard of care for this disease.

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