pSivida Corp. Announces Interim Data From Investigator-Sponsored Uveitis Study

  pSivida Corp. Announces Interim Data From Investigator-Sponsored Uveitis
  Study

Business Wire

WATERTOWN, Mass. -- July 11, 2013

pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a
leader in developing sustained release drugs for the treatment of
back-of-the-eye diseases, today announced interim data from an
investigator-sponsored Phase I/II study of pSivida’s injectable micro-insert
in patients with posterior uveitis. The same micro-insert is being marketed in
the EU as ILUVIEN® for the treatment of chronic Diabetic Macular Edema (DME)
considered insufficiently responsive to available therapies by pSivida’s
collaborative partner, Alimera Sciences. The uveitis application is being
independently developed by pSivida.

Through the first 12 months of enrollment in this study, none of the treated
eyes had a recurrence of uveitis, and inflammation had been reduced in all
treated eyes. By contrast, fellow (untreated) eyes showed either recurrence of
uveitis or worsening or no improvement in inflammation. At the last follow-up
visit, best corrected visual acuity (on the Early Treatment Diabetic
Retinopathy Study eye chart) had improved by an average of more than nine
letters in treated eyes and had declined by an average of one letter in fellow
eyes.

The interim data showed that the micro-inserts were well-tolerated and the
observed safety profile was consistent with the short-term safety profile
reported in clinical studies of ILUVIEN in DME subjects. With one exception,
intraocular pressure (IOP) measurements of treated eyes had all remained in
the normal range. One treated eye, which at baseline had a history of elevated
IOP, required surgery to control pressure.

“We are very happy with this early data,” said Paul Ashton, Ph.D., President
and CEO of pSivida Corp. “They are consistent with our hypothesis that our
micro-insert will treat chronic non-infectious uveitis affecting the back of
the eye with an efficacy profile that is comparable to Retisert, a current
FDA- approved implant for uveitis developed by pSivida, and a side effect
profile that is superior to Retisert and comparable to ILUVIEN in DME,” said
Dr. Ashton.

The three-year, investigator-sponsored Phase I/II study will evaluate the
safety and efficacy of the micro-insert in up to 12 patients with uveitis
affecting the posterior segment (intermediate, posterior and panuveitis).
pSivida has recently initiated the first of two planned Phase III trials for
the use of the micro-insert in the treatment of posterior uveitis, which are
expected to enroll a total of approximately 300 patients. The primary end
point in these trials will be the recurrence of uveitis within 12 months.
pSivida will be permitted to reference much of the data, including the
clinical safety data, from the clinical trials for ILUVIEN for DME conducted
by Alimera.

Alimera has been granted marketing authorization for ILUVIEN for DME in six EU
countries with a seventh pending. Alimera began the commercial launch of the
product earlier last quarter in Germany, and, for private payers, in the UK.
Uptake by the UK’s National Health Service is expected later in the year
following the positive appraisal consultation document issued from NICE in
June. The U.S. Food & Drug Administration accepted Alimera’s resubmission of
the New Drug Application for ILUVIEN for DME with a PDUFA date of October 17,
2013. pSivida will be entitled to receive 20% of the net profits (as defined)
on sales of ILUVIEN for DME by Alimera and a $25 million milestone payment
from Alimera if the FDA approves.

“Both our micro-insert and Retisert deliver the same drug, which has been
shown to be effective in treating uveitis. However, the micro-insert delivers
a lower dosage, which we are optimistic will continue to show similar efficacy
to Retisert in treating the disease,” said Dr. Ashton. “We also expect that
these micro-inserts in uveitis patients will have a comparable side effect
profile to that seen with ILUVIEN in DME. Data from the approximately 1,000
patients who received these micro-inserts in the ILUVIEN DME Phase III studies
showed an incidence of serious elevated IOP (above 30mmHg) that was three
times lower than that shown in the Retisert Phase III trials and an incidence
of required surgery to treat increased IOP that was lower by a factor of 7. As
a result, we are optimistic that our micro-insert will be efficacious for
treating posterior uveitis with a more favorable risk/benefit profile and
fewer side effects than Retisert. Another advantage of these micro-inserts
over Retisert is that the micro-inserts are injected into the eye in an office
visit while Retisert must be surgically inserted.”

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 is
responsible for approximately 30,000 cases of legal blindness, making it the
third largest cause of blindness. Retisert is licensed to and marketed by
Bausch & Lomb.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drugs designed to be released at a controlled and steady rate for
months or years. pSivida is currently focused on treatment of chronic diseases
of the back of the eye utilizing its core technology systems, Durasert™ and
BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the
treatment of chronic Diabetic Macula Edema (DME), licensed to Alimera
Sciences, Inc., has received marketing authorization in Austria, France,
Germany, Portugal, the U.K. and Spain and is awaiting authorization in Italy.
ILUVIEN for DME has not been approved in the US. pSivida has commenced the
first of two pivotal Phase III clinical trials for the treatment of posterior
uveitis with the same micro-insert as ILUVIEN for DME. An
investigator-sponsored clinical trial is ongoing for an injectable,
bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's
FDA-approved product, Retisert® for the treatment of posterior uveitis, is
licensed to Bausch & Lomb. Other technologies under development by pSivida
include protein and antibody delivery systems in early clinical stages.

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. The following are 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: uncertainties with respect to: the actual results of the
investigator-sponsored NDA for posterior uveitis including efficacy, visual
acuity and side effects and the initiation, financing and success of Phase III
posterior uveitis trials including efficacy, side effects and risk/benefit
profile of the posterior uveitis micro-insert; Alimera's ability to finance,
achieve additional marketing approvals, successfully commercialize and achieve
market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME
in the EU; outcome of reimbursement for ILUVIEN in the U.K., Alimera's
resubmission of its NDA for ILUVIEN for DME and its ability to obtain
regulatory approval for, and if approved, to finance, successfully
commercialize and achieve market acceptance of, and generate revenues to
pSivida from, ILUVIEN for DME in the U.S.; initiation, financing and success
of Latanoprost Product Phase II trials and exercise by Pfizer of its option;
development of products using Tethadur and BioSilicon; initiation and
completion of clinical trials and obtaining regulatory approval of product
candidates; adverse side effects; ability to attain profitability; ability to
obtain additional capital; further impairment of intangible assets;
fluctuations in operating results; decline in royalty revenues; ability to,
and to find partners to, develop and market products; termination of license
agreements; competition and other developments affecting sales of products;
market acceptance; protection of intellectual property and avoiding
intellectual property infringement; retention of key personnel; product
liability; consolidation in the pharmaceutical and biotechnology industries;
compliance with environmental laws; manufacturing risks; risks and costs of
international business operations; credit and financial market conditions;
legislative or regulatory changes; volatility of stock price; possible
dilution; possible influence by Pfizer; absence of dividends; and other
factors described in our filings with the SEC. Given these uncertainties,
readers are cautioned not to place undue reliance on such 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.

Follow pSivida on social media:

Twitter: https://twitter.com/pSividaCorp

Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562

LinkedIn: http://www.linkedin.com/company/psivida

Google+:
https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts

The President's Blog: http://www.thechairmansblog.com/paul-ashton

Contact:

IN US:
Martin E. Janis & Company, Inc.
Beverly Jedynak, President
312-943-1123; 773-350-5793 (cell)
bjedynak@janispr.com
or
IN AUSTRALIA:
pSivida Corp.
Brian Leedman, Vice President, Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
 
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