PSivida's Medidur™ Maintains Same High Statistical Significance In Primary Endpoint Through 12 Months In First Phase 3 Trial (p Less Than 0.00000001)

WATERTOWN, Mass., July 27, 2016 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products primarily for eye diseases, today announced its first Phase 3 trial of Medidur for the treatment of posterior uveitis continued to meet its primary endpoint (prevention of recurrence of disease) with high statistical significance through 12 months follow-up (p less than 0.00000001; intent to treat analysis). Posterior uveitis was much less likely to recur in eyes treated with a Medidur injection than those receiving a sham injection through 12 months (26.4% compared to 85.7%). The average increase in intraocular pressure (IOP) at 12 months was only 0.6mmHg more in Medidur-treated eyes than control eyes (1.3mmHg versus 0.7mmHg).

"The continued high efficacy and favorable safety results of Medidur in the treatment of posterior uveitis are impressive. Particularly encouraging is the effectiveness of Medidur in controlling recurrence of disease over the longer 12-month period. Medidur-treated eyes were over 5.2 times more likely to be free of recurrence through 12 months than control eyes," said Dr. Glenn Jaffe, Duke University Robert Machemer Professor of Ophthalmology and Chief of the Division of Retinal Ophthalmology and principal investigator for this trial.

Medidur was generally well tolerated through the last follow-up visit (minimum 12 months, maximum 30 months, average 18 months). The incremental risk of elevation of IOP for Medidur-treated eyes compared to control eyes was lower than it was through six months for over 21mmHg (8.3% versus 10.9%) as well as for the more serious elevation over 25mmHg (5.1% versus 11.3%). Elevated IOP was generally well treated with eye drops, and the percentage of eyes requiring incisional surgery to reduce IOP was essentially the same in Medidur-treated and control eyes through the last follow-up (4.6% versus 4.8%).

Dr. Paul Ashton, president and CEO of pSivida, said, "These results are demonstrating the potential for treating posterior uveitis by delivering a very small amount of drug directly to the back of the eye over an extended period with a single injection. We were pleased to see that over 80% of the Medidur-treated patients who were on systemic meds at baseline were able to come off of them entirely through 12 months."

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