PVA Psividacor Cdi

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced that it plans to file for EU marketing approval of Medidur™ for chronic non-infectious uveitis of the posterior segment of the eye (posterior uveitis) based on data from a single pivotal trial as a result of the high statistical significance achieved in its first Phase 3 clinical trial. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) advised pSivida that, consistent with the published Points to Consider (PtC) of the European Agency for Evaluation of Medicinal Products, an application for a product treating a condition like posterior uveitis could be based on statistically compelling and clinically relevant results from just one pivotal trial. The MHRA recently provided this specific advice in formal minutes of a meeting with pSivida held on October 29, 2015 (prior to the Company’s receipt of topline results for its first Phase 3 clinical trial). With those results now available, pSivida plans to confirm with the MHRA the plan to file for EU marketing approval of Medidur based on one trial. 

“We are delighted with this advice provided by the MHRA. We expect the high statistical significance of the efficacy data, clinical benefits and positive safety data in our first trial will meet the criteria used by MHRA and other EU regulatory authorities to approve a product on the basis of a single pivotal study,” said Paul Ashton, president and CEO of pSivida Corp. “Using data from a single clinical trial would significantly accelerate our filing for EU marketing approval for Medidur. As posterior uveitis affects a similar number of people in the EU and the U.S., accelerated approval in the important EU market would be very beneficial to us.”  

pSivida’s first Phase 3 clinical trial for Medidur for Posterior Uveitis met its primary endpoint of prevention of recurrence of disease at six months with exceptional statistical significance (p < 0.00000001, intent to treat). Exploratory analyses of Medidur-treated eyes compared to control at six months also showed statistical significance: improvement in visual acuity (gain of 15 or more letters on the Early Treatment Diabetic retinopathy Study (ETDRS) Eye Chart) (p = 0.011), reduction in treatment with systemic treatments (steroids, immunosuppressants and biologics) (p < 0.01), and prevention of loss of vision (loss of 15 or more letters) (p < 0.0001). Safety data at six months comparing Medidur-treated eyes to control eyes were also positive, including the observation of modest relative increases in intraocular pressure (IOP) above 21mmHg and cataract surgeries.

Based on the PtC and MHRA minutes, and pending confirmation from the MHRA, pSivida plans to base its EU submission for Medidur for posterior uveitis on safety and efficacy data from the referenced single Phase 3 trial, available safety data from its second Phase 3 trial, data from a short-duration inserter study and data incorporated from ILUVIEN® from DME Phase 3 trials. pSivida expects to file for European approval in the second half of 2016. A U.S. New Drug Application is planned in the first half of 2017 based on results from both of pSivida’s Phase 3 trials.

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 injection-controlled, double-masked trials. The primary endpoint of both trials is prevention of recurrence of posterior uveitis at six months, with patients in both trials followed for three years. The first Phase 3 Medidur trial, which enrolled 129 patients in 16 centers in the U.S. and 17 centers outside the U.S, achieved its primary efficacy endpoint with high statistical significance (p < 0.00000001; intent to treat analysis). The second trial, which is still enrolling patients, will enroll up to 150 patients in approximately 15 centers in India. Assuming favorable results from the second Phase 3 trial, an NDA is anticipated in the first half of 2017.  pSivida plans to seek FDA approval of Medidur based on six-month data from the two Phase 3 trials and a short-duration utilization study of pSivida’s redesigned proprietary inserter, together with data referenced from the Phase 3 trials of ILUVIEN for DME. 

About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis.  Injected into the back of the eye, it provides sustained release of 0.18 mg of the corticosteroid flucinolone acetonide at a controlled rate directly to the retina for three years. Medidur comprises the same micro-insert as ILUVIEN® for DME. ILUVIEN has been approved in the U.S. and 17 EU countries and is sold by pSivida’s licensee in the U.S., U.K., Germany and Portugal.

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 immunosuppressants 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 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 the first half of 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: number of trials and data required for EU marketing application and EU marketing approval; our ability to achieve profitable operations and access to capital; further impairment of our intangible assets; fluctuations in our operating results; 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 flucinolone acetonide side effects; safety and efficacy results of the second Medidur Phase 3 trial, timing of filing and acceptance of the 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
O: 312-943-1123
M: 773-350-5793
bjedynak@janispr.com