pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency.
Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of prevention of recurrence of posterior uveitis at 6 months.
In the 153-patient trial, 21.8% of Durasert-treated patients had a recurrence compared to 53.8% of patients in the sham group.
The company also reported that intraocular pressure elevation was 2.4 mm Hg at 6 months for the Durasert group and 1.3 mm Hg for the sham group. Also, 41.6% of patients in the Durasert required IOP-lowering therapy at any time during the 1st 6 months follow-up and 34.6% for the sham group.
In patients with a natural lens at baseline, 4.9% in the group treated with Durasert needed a cataract surgery through 6 months versus 8.6% in the sham group.
“Our MAA submission is another significant milestone delivered on time by the pSivida team,” president &CEO Nancy Lurker said in prepared remarks. “Durasert 3-year uveitis treatment, our lead product candidate, has now proven to be highly effective in reducing the recurrence of uveitis in 2 Phase III 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.”
pSivida’s Durasert is an injectable, sustained-release drug delivery system that can last for up to 3 years. Administered in an office setting using a needle as small as 25-guage, the micro-insert is 3.5 millimeters in length with a diameter of 0.37 millimeters, according to the company.