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Jul 27, 2016

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."

pSivida has completed initial exploratory analyses and safety evaluations through 12 months of follow up and through the last follow-up visit including the following:

  • 22.9% of Medidur-treated eyes and 11.9% of control eyes showed improvement in visual acuity, gaining 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart through 12 months. The improvement in visual acuity in Medidur-treated eyes seen at six months was maintained at 12 months. This percentage improvement was twice that of control eyes through 12 months, despite the improvement in visual acuity for control eyes. 
  • Of the 65 patients receiving systemic therapy (steroids, immune suppressants and biologics) at baseline, 52.4% of control patients compared to 18.2% of Medidur treated patients were still being administered systemic treatment at 12 months.  These percentages are unchanged from six months.
  • Of the study eyes with a natural lens at baseline, 45.2% of Medidur-treated eyes compared to 9.5% of control eyes required cataract surgery through the last follow-up visit.  Cataracts are both a side effect of treatment with steroids and a natural consequence of posterior uveitis. 51.7% of Medidur-treated eyes and 50.0% of control eyes had already received cataract surgery before enrolling in the study.

In the first Phase 3 trial, a 129-patient, multi-center, randomized and double-blinded trial evaluating the safety and efficacy of Medidur for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis), 87 eyes were injected with Medidur, and 42 eyes were randomized to control and received a sham injection. The primary endpoint of the trial was prevention of recurrence of disease at six months, which the study achieved with high statistical significance (p less than 0.00000001; intent to treat analysis). All other efficacy and safety data analyses are exploratory. Topline results and exploratory analyses are all based on intent to treat population. Patients will be followed for three years from injection at six-month intervals.

About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis. Injected into the back of the eye in an office procedure, it provides sustained release of 0.18 mg of the corticosteroid fluocinolone acetonide at a controlled rate directly to the retina for three years.

About Posterior Uveitis. Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It afflicts 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 approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.

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. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects.

About Medidur Phase 3 Trials. pSivida is conducting two Phase 3 trials to assess the safety and efficacy of Medidur for the treatment of posterior uveitis. These are randomized, sham-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior uveitis at six months, with patients in both trials followed for three years. The first Phase 3 Medidur trial, which is fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S., met its primary efficacy endpoint with high statistical significance. The second trial, which will include up to 150 patients in approximately 15 centers in India, is currently enrolling patients.

About pSivida Corp. pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release, drug delivery products for treating eye diseases. pSivida has developed three of only four FDA-approved sustained-release treatments for back-of-the-eye diseases. The most recent, ILUVIEN®, a micro-insert for diabetic macular edema, licensed to Alimera Sciences, is currently sold in the U.S. and three EU countries. Retisert®, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida's lead product candidate, Medidur™, a micro-insert for posterior uveitis being independently developed, is currently in pivotal Phase 3 clinical trials, with an NDA anticipated in 2017. pSivida's pre-clinical development program is focused on using its core platform technologies Durasert™ and Tethadur™ to deliver drugs and biologics to treat wet and dry age-related macular degeneration, glaucoma, osteoarthritis and other diseases. To learn more about pSivida, please visit www.psivida.com and connect on Twitter, LinkedIn, Facebook and Google+.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: Designation of Medidur as an orphan medicinal product; our ability to achieve profitable operations and access to capital; fluctuations in our operating results; further impairment of our intangible assets; declines in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; safety and efficacy results of the second Medidur Phase 3 trial, data required for, and timing of filing and acceptance of, Medidur NDA and EU marketing approval applications, if at all; ability to use data in a U.S. NDA from trials outside the U.S.; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products using it; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements, even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.


Beverly Jedynak

T:            312-943-1123

M:          773-350-5793


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Source: pSivida Corp

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