pSivida (NSDQ:PSDV) touted data from the 2nd Phase III trial of its Durasert 3-year treatment for posterior segment uveitis. The company reported that the 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 data from this trial confirms previous clinical research demonstrating our 3-year Durasert insert for posterior segment uveitis may significantly help patients suffering from this devastating disease — the third leading cause of blindness,” president & CEO Nancy Lurker said in prepared remarks. “Our market research indicates strong interest in using the product driven by the results of our 1st Phase III clinical trial. We continue to expect the submission of the European Market Authorization Application by the end of June, and we remain on track to also file a New Drug Application with the FDA in the calendar 4th quarter of 2017.”
The Watertown, Mass.-based 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.
“The results of the 2nd Phase III study confirm the efficacy and safety profile of the Durasert 3-year insert demonstrated in the 1st Phase III study. Consistent, durable control of chronic posterior segment uveitis is a critical goal of treatment. The 3-year Durasert insert has the potential to be the 1st product approved to help prevent the recurrence of this devastating condition for up to three years with a single intravitreal injection,” primary investigator Dr. Jyotirmay Biswas said.
“Chronic posterior uveitis is challenging to treat as the disease tends to wax and wane over time. Durasert 3-year insert is a single-injection office-based treatment that can last 2-3 years. Therefore, it addresses the need to help prevent recurrences over an extended time period, rather than to treat them episodically, and may represent an exciting new approach to manage these patients,” Dr. Glenn J. Jaffe, from the Duke University School of Medicine, said.