Biotechnology Events

Home

pSivida Corporation

.

PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

.

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."
More
Source: press release, 9/28/15. http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=933331

.

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

.

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.
More
Source: press release, 5/08/15. http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=911985

.

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: 2015-12-01 - 2015-12-31

Results:

.

pSivida's Medidur™ Maintains Same High Statistical Significance in Primary Endpoint through 12 Months in First Phase 3 Trial (p Less Than 0.00000001)
Incremental Risk of Elevated IOP Relative to Control Decreases Through Last Follow-up Visit
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.
More
Source: press release, 7/27/16. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=981381

.

Additional Favorable Six-Month Safety Results for pSivida's Medidur™ for Posterior Uveitis
Small Average Increase in IOP Relative to Control
Comparable Percentage Treated with Eye Drops for Elevated IOP

WATERTOWN, Mass., March 15, 2016 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today reported favorable results from additional analysis of the six-month safety data from pSivida's first Phase 3 pivotal clinical trial for Medidur for posterior uveitis.

There was a small average increase in intraocular pressure (IOP) in Medidur-treated eyes through six months relative to control. Medidur eyes increased on average only 1.1mmHg more than control eyes (1.8mmHg increase compared to 0.7mmHg).

The percentage of eyes requiring treatment with eye drops for IOP was comparable between Medidur and control eyes. Only 1% more Medidur-treated eyes than control eyes received treatment with eye drops for elevated IOP (19% compared to 18%) through six months.

"We are very pleased with this new safety data through six months showing a small average increase in IOP for Medidur treatment relative to control and comparable incidence of treatment with eye drops for IOP in both groups. The average increase in IOP for Medidur-treated eyes was lower than that observed in the same period in the clinical trials for Ozurdex® and Retisert®, the two FDA-approved sustained release treatments for posterior uveitis," said Dr. Paul Ashton, president and CEO of pSivida. "Our first trial also showed Medidur to be highly effective. We earlier reported that this trial achieved its primary end point - prevention of recurrence of disease at six months -- with high statistical significance (p less than 0.0000001, intent to treat analysis)."

pSivida plans to meet with the FDA next quarter to discuss the first Phase 3 trial results and to confirm that data from two trials will continue to be required for a U.S. New Drug Application (NDA) currently planned for the first half of calendar 2017. As a result of the high statistical significance achieved in the first Phase 3 trial, pSivida plans to file for European Union (EU) marketing approval based on data from the single trial in late 2016.
More
Source: press release, 3/15/16. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=960705

.

pSivida's Medidur™ Meets Primary Efficacy Endpoint in Phase 3 Trial: High Statistical Significance in Prevention of Recurrence of Posterior Uveitis (p Less Than 0.00000001)
Statistical Significance in Improvement in Visual Acuity and Reduction in Systemic Therapy

Medidur next to pencil tip
Medidur™, pictured below the pencil, 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 a corticosteroid directly to the retina at a controlled rate for three years. This technology used in Medidur, developed by pSivida Corp., can deliver small molecule drugs at consistent release rates for pre-determined period of time - weeks, months or years - and underlies three of only four FDA-approved sustained release treatments for back-of-the-eye diseases. pSivida announced highly statistically-significant results of the first of two Phase 3 trials for Medidur for posterior uveitis.

Positive Safety Data

WATERTOWN, Mass., Dec. 22, 2015 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced positive topline results from its first Phase 3 clinical trial evaluating the safety and efficacy of Medidur™ for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis). The 129 patient, multi-center, randomized and double-blinded trial was highly statistically significant in meeting its primary efficacy endpoint of prevention of recurrence of disease at six months (p less than 0.00000001; intent to treat analysis). Safety results were positive. Only 10.9% more Medidur-treated eyes than control eyes experienced an increase in intraocular pressure (IOP) above 21 mmHg through six months, which was reduced to 6.1% through the most recent follow-up visits (some as long as 24 months). In the Medidur trial, 87 eyes were treated with Medidur, and 42 eyes were randomized to control and received a sham injection.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/b42de5fa-ff6b-480d-8c...

At six-months of follow-up:

18.4% of Medidur-treated eyes compared to 78.6% of control eyes had experienced recurrence of posterior uveitis (a statistically significant p less than 0.00000001).
23.0% of Medidur-treated eyes compared to 4.9% 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 (a statistically significant p = 0.011).
31.0% of control eyes compared to 4.6% of Medidur-treated eyes had lost 15 or more letters from baseline on the ETDRS Eye Chart for at least one observation (a statistically significant p less than 0.0001).
Of the 65 patients receiving systemic therapy (steroids, immuno-suppressants and biologics) at baseline, 52.4% of control patients compared to 18.2% of Medidur-treated patients were still being administered systemic treatment (a statistically significant p less than 0.01).
27.6% of Medidur-treated eyes compared to 16.7% of control eyes had experienced an increase in intraocular pressure (IOP) above 21 mmHg for at least one observation.
Of the 64 study eyes with a natural lens at baseline, 9.5% of Medidur-treated eyes compared to 4.8% of control eyes had required cataract surgery.
"The results of this Phase 3 trial are extraordinary. With a single injection, Medidur showed the ability to control the recurrence of posterior uveitis, improve visual acuity and prevent vision loss," 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. "The high level of statistical significance achieved in this trial is dramatic and, along with the compelling benefit-risk ratio, suggests an important treatment option for patients who are typically treated with repeated systemic steroids, immuno-suppressants or biologics, often facing recurring attacks of the disease as well as systemic side effects."

The IOP elevation results for Medidur compare favorably to the Phase 3 trial results for ILUVIEN® for diabetic macular edema, which comprises the same micro-insert as Medidur. Other safety results were also positive. Through six months, 2.3% of Medidur-treated eyes and no control eyes required an incisional procedure to reduce IOP. Through the most recent follow-up, 3.4% of Medidur-treated eyes compared to 2.4% of control eyes required an incisional procedure to reduce IOP.

"The results from this Phase 3 trial indicate that Medidur has the opportunity to be an effective, safe and convenient treatment for this blinding eye disease, avoiding the potentially serious side-effects and administration compliance challenges of the cycles of systemic steroids, immuno-suppressants and biologics now used to treat the disease," said Dr. Charles Foster, Clinical Professor of Ophthalmology at Harvard Medical School and Founder and President of the Massachusetts Eye Research and Surgery Institution. "The ability to administer a three-year course of Medidur therapy for posterior uveitis in a single, in-office injection could allow many patients to significantly improve treatment outcomes and vision, reduce side effects and drastically simplify patient compliance as compared to current treatment alternatives."

The primary endpoint of pSivida's Phase 3 trial was prevention of recurrence of disease at six months. All other efficacy and safety data analyses were exploratory. Topline results and exploratory analyses were all based on intent to treat population.
More
Source: press release, 12/22/15. http://investors.psivida.com/releaseDetail.cfm?ReleaseID=947883

.