A second phase 3 trial of pSivida's Durasert 3-year treatment for posterior segment uveitis achieved the trial’s primary endpoint. The study involved 153 patients and the primary endpoint was prevention of recurrence of posterior uveitis at 6 months with patients continuing to be followed for 36 months. Durasert 3-year insert demonstrated a significant reduction in the recurrence of posterior segment uveitis through six months; 21.8% of Durasert-treated patients had a recurrence compared to 53.8% of patients in the sham group (P<0.001).
“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," Nancy Lurker, President and CEO of pSivida Corp, said in a company news release. “Our market research indicates strong interest in using the product driven by the results of our first phase 3 clinical trial. We continue to expect the submission of the European Market Authorization Application (MAA) by the end of June, and we remain on track to also file a new drug application (NDA) with the FDA in the calendar fourth quarter of 2017.”
Additional safety results from the trial included:
- Intraocular pressure (IOP) elevation, which can lead to glaucoma, was 2.4 and 1.3 mm Hg (mean) at 6 months (vs baseline) for Durasert and sham, respectively.
- Patients requiring IOP-lowering therapy at any time during the first 6 months follow-up were 41.6% for Durasert and 34.6% for sham. No subject required IOP surgery during the first 6 months of follow-up.
- In patients with a natural (phakic) lens at baseline, 4.9% in the Durasert group required a cataract surgery through 6 months compared to 8.6% in the sham group.
Posterior segment uveitis is a chronic, noninfectious 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., posterior uveitis affects between 80,000 – 100,000 people. 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.
“The results of the second phase 3 study confirm the efficacy and safety profile of the Durasert 3-year insert demonstrated in the first phase 3 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 first product approved to help prevent the recurrence of this devastating condition for up to 3 years with a single intravitreal injection,” Dr. Jyotirmay Biswas, Professor of Ophthalmology and Director of Uveitis & Ocular Pathology Department, Sankara Nethralaya Ophthalmic Center, Tamil Nadu, India and primary investigator of the study, said in the news release.
“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, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, NC and one of the world’s leading uveitis experts, said in the news release.