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pSivida Corporation

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December 19, 2016
To Our Shareholders:

As 2016 draws to a close, I want to provide you with an update on our progress at pSivida. Since I joined the Company in September of this year, I have undertaken a thorough review of the company’s assets and how we are deploying our people, our technology and our capital. I am very pleased with the significant strength of our proven Durasert ® sustained release drug technology and the scientific, regulatory and manufacturing team here at pSivida, along with the corporate and administrative staff. We have a talented group of people who are very committed to seeing our products brought to market for the benefit of patients as well as our shareholders. We recently have strengthened the team by the addition of Dr. Dario Paggiarino, our Chief Medical Officer, who joined in August, and Deb Jorn, a proven commercial and licensing executive who joined in November. Both Dario and Deb bring a wealth of experience from multiple biopharmaceutical companies to enhance the already talented group of people here at pSivida. Together, we are keenly focused on executing our operating plan and delivering results.

While we continue to develop our novel sustained release drug technologies, we are shifting the deployment of our efforts and capital more towards our proven Durasert technology for small molecules and with established drugs that are already approved by the regulatory authorities. This will allow us to take on less technology and regulatory risk, while potentially bringing products to market faster.

We currently have three programs that are well positioned to achieve multiple significant catalysts during 2017. In addition, a key objective for our team is to increase the number of partnered collaboration programs based on our unique technologies as the year progresses. A brief review of progress since our third quarter report and conference call with investors follows:

Our Durasert three-year treatment for posterior segment uveitis met its enrollment target in the second uveitis Phase 3 trial of 150 patients in September. We continue to expect to complete the readout from this second trial by mid-year 2017. The first Phase 3 study data was positive and highly statistically significant and will be used in our E.U. marketing authorization application, for which we continue to target a first half 2017 submission. Our team is actively pursuing a partnership to market the Durasert three-year treatment for posterior segment uveitis in Europe, and as developments merit we will update you on this key strategic commercial effort. At the same time, should our second Phase 3 trial also prove to have positive results, as we expect, we remain confident in our ability to file a New Drug Application (NDA) for this product to the U.S. Food & Drug Administration (FDA) during the second half of 2017.

In addition to the three-year Durasert treatment, we have begun a development program for a next generation Durasert bio-erodible shorter duration treatment for posterior segment uveitis. We continue to plan to begin pre-clinical safety and PK studies of this product candidate in the first half of 2017.

The Hospital for Special Surgery (HSS) and pSivida investigator-sponsored clinical study of a Durasert implant to treat severe Osteoarthritis (OA) of the knee continues. The implant is designed to provide long-term pain relief for this condition, which, if effective, could potentially result in the delay of knee replacement surgery. The study is an open-label, single dose, safety and tolerability study of the screw implant to deliver dexamethasone, a corticosteroid previously proven to provide pain relief in knee OA. To date, three patients have received the implant and full enrollment will be reported when achieved.

In addition, we are encouraged by the progress the team has made in identifying and pursuing additional collaborations with drug developers for our Durasert and potential Tethadur technologies and in out-licensing our EU rights for our Durasert Uveitis product. As developments get finalized, we will announce additional collaborations.

While we move to advance both the clinical and commercialization efforts of the company, we also have taken a hard look at our infrastructure and costs and have implemented actions designed to reduce administrative costs over the long term. At the same time, we are expanding our efforts to educate investors about our company, its progress and its potential. I’ve just finished a series of meetings last week in the Midwest and we are planning for a very full schedule during the JP Morgan Healthcare Conference in San Francisco January 9-11, 2017.

In summary, we are very excited about our potential to build value over the next year. Specifically, our goal is to achieve the following catalysts by this time next year:
· Submit E.U. marketing approval application for Durasert three-year treatment for posterior segment uveitis
· Enter into a strategic partnership to market the Durasert treatment for uveitis in Europe
· Announce results of our second Phase 3 clinical trial in posterior segment uveitis by mid year 2017
· Submit NDA to the U.S. FDA for Durasert three-year treatment for posterior segment uveitis in the second half of 2017
· Announce 24-week post-treatment results of HSS investigator-sponsored study of Durasert implant to treat severe OA
· Enter into additional collaborations with drug developers for our Durasert and potential Tethadur technologies

We look forward to reporting on our progress as details are finalized. If we can answer any questions, please contact our investor relations team at 212-850-6020 and thank you for your continued support of pSivida.

Best wishes for a healthy, happy holiday season,

Nancy Lurker
President & CEO

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Phase 3 trial of Medidur™ in Posterior Segment Uveitis Meets Enrollment Target
Study is the Second of Two Ongoing Phase 3 Trials in Support Of Product Registration in the US

EU Filing Remains on Track for 1Q2017 Filing

WATERTOWN, Mass., Oct. 04, 2016 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug technologies for eye diseases, announced that its second Phase 3 trial of Medidur in chronic, non-infectious posterior segment uveitis met its target enrollment of 150 patients. The trial is being conducted in clinical sites in India, with the same study design and endpoints as the first Phase 3 trial conducted in the US, EU and India. The results of both Phase 3 trials will support US product registration, with NDA submission planned for the second half of 2017. Filing for EU registration remains on track for the first calendar quarter of 2017.

"We are very pleased that the second Phase 3 trial of Medidur in posterior segment uveitis has met its patient enrollment goal on target and as expected," said Nancy Lurker, President and CEO of pSivida Corp. "Both Phase 3 trials are generating efficacy and safety data critical to regulatory filings in support of product registration. Reaching today's milestone brings us a step closer to making Medidur available to thousands of patients battling with recurrent episodes of ocular inflammation and the prospect of losing vision irreversibly."

This first Medidur trial met the primary efficacy endpoint of prevention of recurrence of posterior segment uveitis at six months in December 2015. Primary efficacy endpoint readout in the second study is expected in the second half of 2017.
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Source: press release, 10/04/16. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=991962

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Paul Ashton, President and CEO, gave guidance for the timing of data from the second phase-III trial of Medidur for posterior uveitis and filing of an NDA. He stated, "In light of the outstanding topline results, we plan to file for EU approval based on only one Phase 3 trial with a plan of filing in Europe by the end of 2016. We also plan to meet with the FDA to confirm its requirements for an NDA, with a filing based on the results of two trials expected in the first half of 2017."
Source: Q2 FY 2016 earnings conference call, 2/08/16.

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September 28, 2015

pSivida Announces NDA for Medidur™ Now Planned Using Six-Month Efficacy Data from Both Phase III Trials; FDA Concurs
Top-Line Data from First Trial Expected December 2015

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, announced that the Company now plans to file a New Drug Application (NDA) for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials. The U.S. Food & Drug Administration (FDA) has advised pSivida that this data will be acceptable for review by the agency. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. As six-month visits in the first trial will be completed this month, top-line results from the first Phase III trial are now anticipated to be reported in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017.

"We are very pleased that the FDA has agreed to review an NDA for posterior uveitis based on six-month efficacy data," said Dr. Paul Ashton, president and CEO of pSivida. "The primary end-point of the Phase III trials is recurrence of disease, which in the majority of patients occurs typically within six months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that six-month data from our two trials will show safety and efficacy. We look forward to being able to announce the top-line results from the first trial at the end of this year."
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Source: press release, 9/28/15. http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=933331

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May 19, 2015

pSivida Reports Positive IOP Safety Data in Phase III Trial of Medidur™ for Posterior Uveitis

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV); (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced positive safety data from its ongoing assessment of masked safety data from its first Phase III clinical trial of Medidur™ for posterior uveitis, a blinding eye disease. At three months, only 4% more study eyes (2/3 of which received Medidur) experienced elevated intraocular pressure (IOP) than the fellow non-study eyes (none of which received Medidur). Initial IOP elevation is an indication of the likelihood of subsequent clinically significant IOP increases. The minimal difference observed in elevated IOP in the assessment suggests highly favorable results for a key safety measure of the trial, the number of eyes that develop clinically significant increases in IOP within 12 months of receiving Medidur relative to control eyes.

"These data are very encouraging for the safety profile of Medidur," said Dr. Paul Ashton president and CEO of pSivida Corp. "A significant treatment challenge with posterior uveitis patients is managing the serious side effects of prolonged steroid use, the current first-line treatment. A therapy that can provide the benefits of steroids on a sustained basis for three years with a single injection with a lower incidence of side effects would be a very significant advance in treatment of this disease."

The assessment of masked data compared the elevation of IOP over 21mmHg at three months study eyes and fellow eyes for the 105 out of 129 enrolled subjects with at least three month follow-up data.

"We are very optimistic for the final IOP safety results in this trial," said Dr. Ashton. "We originally expected that the final IOP safety profile for Medidur would be at least as good as the IOP safety profile of the FDA-approved ILUVIEN® for diabetic macular edema (DME) (which uses the same micro-insert as Medidur and delivers the same dose of the same drug), and much better than the IOP safety profile of the FDA-approved Retisert® (which delivers a higher dose of the same drug in Medidur). On the basis of this ongoing assessment of masked study safety data, we now believe the final IOP results in the Medidur trial could be even better than those shown in the ILUVIEN and Retisert Phase III trials. At 36 months, 24% more patients treated with ILUVIEN and 45% more patients treated with Retisert required medication for elevated IOP than controls in their Phase III trials. We expect top line results from this first Phase III trial of Medidur to be available in Q2 2016, and with favorable results from this and our second trial, which has just been initiated, we intend to file for U.S. approval in the first half of 2017."
More
Source: press release, 5/19/15. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=913817

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In recent meetings, pSivida reached agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for Medidur that allows for a new drug application (NDA) to be filed in the first half of 2017. The FDA agreed, pending clinical trial results, that it would accept an NDA based on data from the ongoing Medidur Phase III trial (which has a primary endpoint at 12 months), data from a second Phase III trial with a shorter, 6-month primary endpoint and data referenced from the already completed Phase III ILUVIEN trials. pSivida will also submit data from a small utilization study of its newly designed inserter that uses a standard 27 gauge needle.

"We are very pleased that we have a clear regulatory path that should permit us to file the NDA for Medidur with only a short delay from the timing we anticipated based on a single Phase III trial. We had budgeted for the second trial pending FDA guidance, so the second trial does not change our liquidity projections," said Dr. Ashton. This quarter we completed enrollment in the first Phase III trial with the longer 12-month primary endpoint, and we expect top-line data in the second quarter of 2016. We have already initiated the second Phase III trial, which will enroll up to 150 patients in India.
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Source: press release, 5/08/15. http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=911985

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March 26, 2015

pSivida Corp. Completes Targeted Enrollment of Phase III Trial of Medidur™ for Posterior Uveitis

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced the completion of the originally targeted enrollment of 120 patients in its pivotal Phase III clinical trial of Medidur™ for the treatment of posterior uveitis, a blinding eye disease. pSivida will permit 10 additional patients seeking entry into the trial who met the entry criteria to enroll. pSivida expects to report top line data from the trial in the second half of 2016, and based on the results, to file for regulatory approval in late 2016 or early 2017.

"This is a major advance in the treatment of uveitis, in my opinion, with the delivery of medication into the vitreous cavity without the need for travel to an operating room and with effective provision of corticosteroid for a sustained three years," said Dr. C. Stephen Foster, president and CEO of Massachusetts Eye Research & Surgical Institute; founder and president of Ocular Immunology and Uveitis Foundation and a clinical professor of ophthalmology at Harvard Medical School. Dr. Foster's site enrolled the most patients in the study.

Medidur is an injectable micro-insert delivering the steroid flucinolone acetonide (FA) on a sustained basis for 36 months. Medidur uses the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for diabetic macular edema (DME) developed by pSivida, which has been approved in the U.S. and in 15 EU countries to date. Medidur is inserted via a redesigned applicator that utilizes a needle of the same gauge as that typically used for intra-ocular injections.

Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina. 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 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 progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.

"Based on results of a Phase II study and prior experience with this implant, we believe that Medidur will provide improved outcomes compared to standard of care but with a significant reduction in side effects. Medidur should also lower treatment costs and offer the reduced invasiveness of an injection every three years compared with the frequent administration of existing therapies," said Dr. Paul Ashton, President and CEO of pSivida Corp. "We are focused on providing solutions for retinal diseases and believe that this study will demonstrate the safety and effectiveness of Medidur."

The Medidur Phase III trial is a double-blind study comparing injections of Medidur to sham injections on a two-to-one basis. Patients are enrolled in 16 centers in the U.S. and 17 centers in the EU and India. The primary end point of the trial is recurrence of posterior uveitis within one year. pSivida plans to seek approval based on the safety and efficacy data from this single Phase III trial together with short term data from a utilization study of pSivida's proprietary inserter. The FDA has confirmed that pSivida can reference much of the data, including the clinical safety data, from the Phase III clinical trials of ILUVIEN for DME.
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Source: press release, 3/26/15. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=903433

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pSivida's lead development product, Medidur™ for the treatment of posterior uveitis, is being tested in a pivotal Phase III trial. Enrollment is expected to be completed around the end of March 2015. With a primary end-point of recurrence of disease at 12 months, top-line data from the trial is anticipated in the first half of calendar 2016. The Company expects to review its plan with the FDA this quarter to seek U.S. regulatory approval based on data from this single trial, rather than two trials, together with supplemental clinical data on pSivida's proprietary inserter. Medidur uses the same injectable, sustained-release micro-insert as ILUVIEN for DME (same design, same drug, same polymer, same release rate). The FDA has agreed that pSivida can use much of the data, including clinical safety data, from the completed ILUVIEN Phase III trials to support an application for Medidur.
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Source: press release, 2/05/15. http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=895039

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Paul Ashton, President and CEO, commented on the progress being made for the phase-III program of Medidur for posterior uveitis. He stated, "Enrollment for the first of our two planned pivotal phase-III trials for Medidur is expected to be completed by the end of the summer. Based on the clinical trial results for Retisert, the FDA approved product for the treatment of posterior uveitis that we developed and licensed to Bausch & Lomb and on the results of Iluvein for DME we expect our trials for Medidur will show that it is as effective as Retisert, but with a better safety profile. We are developing Medidur independently."
Source: F2Q Fiscal 2014 earnings conference call, 2/07/14.

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July 1, 2013
pSivida Corp. Announces Initiation of Phase III Clinical Trial in Posterior Uveitis

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that it has initiated the first of two planned pivotal Phase III trials of its micro-insert for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, a major cause of vision loss in the U.S.

"We are extremely pleased that our first three U.S. clinical sites have begun recruiting patients for this trial," said Paul Ashton, Ph.D., President and CEO of pSivida. "We are very optimistic that our micro-insert will be efficacious for the treatment of posterior uveitis with a more favorable risk/benefit profile, fewer side effects and greater ease of administration than Retisert®, our current FDA-approved product for the treatment of the same disease."

The micro-insert, a tiny tube about the size of an eyelash that releases the steroid fluocinolone acetonide on a sustained basis for up to 36 months, is the same micro-insert licensed by pSivida to Alimera Sciences, Inc. Alimera has received marketing approval for the micro-insert in six EU countries for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and has commenced the direct commercialization of the micro-insert in Germany and the United Kingdom under the name ILUVIEN®. The FDA has set a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 for ILUVIEN. pSivida did not license the micro-insert to Alimera for the treatment of uveitis and is developing this product without a partner.

This is the first of two pivotal trials required by the FDA for approval of the micro-insert for the treatment of posterior uveitis. These trials are planned to involve approximately 15 U.S. clinical sites and additional sites world-wide. Both trials will have a primary end-point of recurrence of posterior uveitis at 12 months and are planned to involve approximately 300 patients in total. If the results of the trials are positive, the data will be used by pSivida to submit a New Drug Application to the FDA. The FDA has confirmed that pSivida will be able to reference much of the data, including the clinical safety data, from Alimera's Phase III clinical trials of ILUVIEN for chronic DME.

Posterior uveitis is an inflammatory disease of one of the layers of the eye. In the U.S., posterior uveitis affects approximately 175,000 people and can be difficult to treat effectively, resulting in an estimated 30,000 cases of blindness in the U.S.

"In our uveitis trials, we expect to maintain similar efficacy to that seen in the Retisert Phase III trials but with a similar side-effect profile to that seen in DME patients in the Phase III studies for ILUVIEN," said Dr. Ashton. "The Retisert implant is FDA approved for posterior uveitis and the micro-insert delivers the same drug as Retisert, so we expect the micro-insert to be efficacious. Based on the Phase III studies for ILUVIEN, we also expect the micro-insert to have a lower incidence of serious increased in intraocular pressure (IOP) than Retisert. The ILUVIEN studies showed an incidence of serious elevated IOP that was three times lower than that seen in the Retisert Phase III trials, and the incidence of patients requiring surgery for increased IOP in the ILUVIEN studies was seven times lower. The micro-insert releases drug at a slower rate and is also easier to administer than Retisert, because the micro-insert is injected in an office visit while Retisert must be implanted in a surgical procedure."
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Source: press release, 7/01/13. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=774660

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Paul Ashton, President and CEO, commented on the progress being made with the Iluvien phase-III program for posterior uveitis. He stated, "We had a very positive meeting with the FDA and they have reviewed our plans for phase-III clinical trials. We expect our phase-III clinical for this micro-insert for posterior uveitis to begin enrolling patients on schedule by the end of this quarter."
Source: Q3 Fiscal 2013 earnings conference call, 5/13/13.

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Paul Ashton, President and CEO, commented on the progress being made with the Iluvien phase III program for posterior uveitis. He stated, "Now, moving from strategy to tactics, our lead development product, which we plan to move forward ourselves without a partner is our micro-insert to treat posterior uveitis. We expect it will begin phase III clinical trials next quarter on schedule."
Source: Q2 Fiscal 2013 earnings conference call, 2/06/13.

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Paul Ashton, President and CEO, commented on the upcoming phase III trial for Posterior Uveitis. He stated, "The FDA has cleared the IND for the micro-insert to go straight into Phase III clinical trials in posterior uveitis. The FDA has agreed that the primary end points for these studies can be the recurrence of the disease at 12 months and the FDA has agreed that we can reference much of the pre-clinical and clinical data including the human safety data already supplied under the NDA for DME."
Source: Q4 Fiscal 2012 earnings conference call, 9/24/12.

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July 19, 2012
pSivida Corp. Receives FDA Clearance for Pivotal Trials for Injectable Sustained-Release Micro-Insert to Treat Uveitis

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to treat posterior uveitis with pSivida's injectable sustained-release micro-insert. pSivida is now permitted to move directly to two Phase III trials to treat patients with posterior uveitis. These trials, which pSivida expects would enroll a total of 300 patients, would be in addition to the investigator-sponsored trial studying the same device for posterior uveitis announced last month.
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Source: press release, 7/19/12. http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=693232

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A Multi-Center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Enrollment: 129
Study Start Date: June 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01694186?term=pSivida&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Medidur (Iluvien) (fluocinolone acetonide) PUOphthalmologyPosterior UveitisAnti-inflammatoryPhospholipase A2

Mechanism of action: Medidur (Iluvien) (fluocinolone acetonide) consists of a tiny, cylindrical polyimide tube that contains 190 µg of fluocinolone acetonide (FAc), a corticosteroid with a history of treating ocular diseases. It is thought to act by induction of phospholipase A2 inhibitory proteins (lipocortins). Lipocortins appear to control biosynthesis of potent mediators of inflammation (prostaglandins, leukotrienes) by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.Iluvien is administered as an intravitreal insert, and its design provides for a sustained release that delivers a low, steady, daily dose of fluocinolone acetonide over an anticipated 24-to-36-month period. Iluvien is designed to be inserted into the patient’s eye in a retinal specialist’s office using an intravitreal injection, a procedure commonly employed by retina specialists.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2017-07-01 - 2017-08-31

Results: Pending