pSivida (NSDQ:PSDV) touted 1-year follow-up data yesterday for the company’s Durasert 3-year treatment of posterior segment uveitis. The data, which was presented at the Association for Research in Vision and Ophthalmology annual meeting, is from pSivida’s 1st phase III trial.
The data showed that the 3-year uveitis implant significantly reduced the recurrence of posterior segment uveitis through 12 months – 27.6% of patients treated with Durasert had a recurrence, compared to 85.7% of patients in the sham group. In phakic patients, 33.3% in the Durasert group required a cataract surgery in the year-long follow-up, versus 4.8% of patients in the sham group.
The best corrected visual acuity gain of 15 letters or more at 6 and 12 months was 23% and 22.4% for Durasert and 7.3% and 10.3% for the sham procedure.
Intraocular pressure elevation was 1.3mm for Durasert at 12 months and 0.2mm for sham, on average. About 26.4% of Durasert patients needed IOP-lowering therapy after 1 year, compared to 26.2% for their counterparts in the control group.
“The data presented today by Dr. Jaffe continues to reinforce pSivida’s proven technology and depth of our innovation,” president & CEO Nancy Lurker said in prepared remarks. “The results, both at six and 12 months, demonstrated a significant reduction in the prevention of recurrence of posterior segment uveitis – a devastating disease and the third leading cause of blindness. Our market research indicates strong interest in using the product driven by the results of our first Phase III clinical trial demonstrating a significant, and durable, reduction in recurrence rates, improvements in BCVA and a favorable tolerability profile at 12 months. We continue to expect the 1st read-out of our 2nd Phase III clinical trial of Durasert and submission of the European Market Authorization Application (MAA) by the end of June. We remain on track to also file a New Drug Application (NDA) with the FDA in the calendar 4th quarter of 2017.”
PSDV shares were trading at $1.92 in afternoon activity, up 1.2%.