The 153-patient study found that there was a significant reduction in the recurrence of posterior segment uveitis through 12 months in the group treated with pSivida’s drug-releasing ocular insert, Durasert.
Just 37% of people treated with Durasert experienced a recurrence compared to 71.2% of patients in the control group. The portion of patients who required medication to lower their intraocular pressure during the 12 months of follow-up was 50.5% for the Durasert group and 51.9% for the control group. Just one patient, who was treated with Durasert, needed IOP surgery.
“The continued positive efficacy and safety data for Durasert, now confirmed in two separate Phase III studies at both six and 12 months, is encouraging for patients that are suffering from posterior segment uveitis,” primary investigator Dr. Glenn Jaffe said in prepared remarks. “While today’s standard of care treatment options are mainly directed at controlling flares, Durasert is designed to help prevent flares for up to three years with a single injection administered in an office setting.”
“As we await the US Food and Drug Administration’s decision on acceptance of our New Drug Application submitted in January, we are solidifying our go-to-market plan,” president & CEO Nancy Lurker added. “We continue to receive highly positive feedback from specialists regarding Durasert three year for posterior segment uveitis, which bolsters our team’s confidence that there will be strong interest to treat patients dealing with this devastating disease, which is the third leading cause of blindness, pending a favorable regulatory review.”
The Watertown, Mass.-based company also reported that it topped expectations on Wall Street today with its second quarter financial results for FY18.
pSivida posted a net loss of -$5.8 million, down from -$67,000 in the second quarter last year, on sales of $933,000 for the three months ended Dec. 31. Revenue for the quarter also fell dramatically compared to the same period last year, when it reported that it brought in $6 million in sales.
pSivida pointed out that the year-over-year differences are largely due to the $5.6 million it received last year when it ended an R&D collaboration with Pfizer.
Adjusted to exclude 1-time items, earnings per share were -13¢, ahead of consensus on The Street, where analysts were looking for sales of $510,000.