pSivida Announces ILUVIEN® Receives Marketing Authorization in Italy for Treatment of Chronic Diabetic Macular Edema

  pSivida Announces ILUVIEN® Receives Marketing Authorization in Italy for
  Treatment of Chronic Diabetic Macular Edema

Business Wire

WATERTOWN, Mass. -- June 23, 2014

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of
sustained release, drug delivery products for treating eye diseases, today
announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has
granted marketing authorization to ILUVIEN® for the treatment of vision
impairment associated with chronic diabetic macular edema (DME) considered
insufficiently responsive to available therapies.

The ILUVIEN marketing authorization notice was published on June 18 in the
Gazzetta Ufficiale della Repubblica Italiana, the official journal of record
of the Italian government. Designated a C Class product in Italy, ILUVIEN will
be available initially to private paying patients, and pSivida’s licensee,
Alimera Sciences, is pursuing H Class designation for ILUVIEN with the Italian
regulatory authorities, which, if granted, would expand patient access to the

The Italian authorization marks the seventh national approval in the EU.
ILUVIEN is authorized in Austria, the United Kingdom, Portugal, France,
Germany and Spain and is commercially available in the U.K. and Germany.
Alimera is also engaged in a Repeat Use Procedure through Mutual Recognition
(MRP) to obtain a positive opinion for approval from another 10 EU countries.
In the United States, ILUVIEN is awaiting a decision from the FDA on the
refiled NDA, with a Prescription Drug User Fee Act (PDUFA) goal date of
September 26, 2014.

“We are very pleased that ILUVIEN has been granted marketing authorization in
all seven EU countries where initial applications have been submitted,” said
Dr. Paul Ashton, President and CEO of pSivida. "Additionally, should ILUVIEN
be approved by the FDA, we are entitled to a $25 million milestone payment
from Alimera in addition to net profit payments on Alimera’s sales of

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs 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™, including Tethadur™. pSivida has instituted the
first of two planned pivotal Phase III clinical trials for its lead
development product, Medidur™, an injectable, sustained release micro-insert
for the treatment of posterior uveitis, a chronic back-of-the-eye disease.
ILUVIEN® for the treatment of chronic DME considered insufficiently responsive
to available therapies, which uses the same micro-insert as Medidur and is
licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and
has also received marketing authorization in Austria, France, Portugal, and
Spain and is awaiting authorization in Italy. Alimera has filed for ten
additional EU country approvals through the Mutual Recognition Procedure.
Alimera is seeking approval of ILUVIEN in the U.S. An investigator-sponsored
clinical trial is ongoing for an injectable, bioerodible micro-insert to treat
glaucoma and ocular hypertension, a product candidate on which Pfizer Inc. has
an option. pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb
Incorporated, provides long-term, sustained drug delivery to treat posterior

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: ability of STA to achieve marketing
approvals, adequate pricing and reimbursement and market acceptance for and
successful commercialization of ILUVIEN for DME in Australia and New Zealand;
Alimera's ability to finance, achieve additional marketing approvals, obtain
adequate pricing and reimbursement for, successfully commercialize and achieve
market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME
in the EU; Alimera's 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.; the
ability to finance, complete and achieve a successful outcome for Phase III
trials for, and file and achieve marketing approvals for, Medidur for
posterior uveitis, including achieving acceptable risk-to-benefit and safety
profiles in light of the CRL for ILUVIEN; initiation, financing and success of
Latanoprost Product Phase II trials and any exercise by Pfizer of its option;
ability of Tethadur to successfully deliver proteins, peptides and other large
biologic molecules; ability to develop product candidates and products and
potential related collaborations; initiation and completion of clinical trials
and obtaining regulatory approval of product candidates; continued sales of
Retisert; adverse side effects; ability to attain profitability; ability to
obtain additional capital; further impairment of intangible assets;
fluctuations in operating results; decline in royalty income; 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; 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. 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. 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

Follow pSivida on social media:





The President's Blog:


Martin E. Janis & Company, Inc.
Beverly Jedynak, President, +1 312-943-1123
M: +1 773-350-5793
Press spacebar to pause and continue. Press esc to stop.