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 Dr. Paul Ashton, president and CEO of pSivida Corp.,
will speak at a special workshop focusing on ocular drug delivery just
prior to the start of the Controlled Release Society (CRS) 2015 Annual
Meeting being held July 26-29 in Edinburgh, Scotland. Dr. Ashton will
address "The Complete Story - Going through Regulatory Approval" during
the "Ocular Drug Delivery - Challenges of Matching New Technologies with
Drug Pharmacokinetics" workshop to be held on Saturday, July 25.
pSivida's patented Durasert™ technology, which can deliver drug for a
predetermined period ranging from months to years, is the basis of three
of the only four sustained release products approved by the FDA to treat
back of the eye diseases. The most recent is ILUVIEN® for diabetic
macular edema. Medidur™ for posterior uveitis is in Phase III clinical
trials. These products, which use the same injectable micro-insert,
provide sustained delivery of a corticosteroid to the back of the eye
for three years from a single injection.
According to the organizers, "The global ophthalmic pharmaceutical
market is expected to be worth $22 billion by 2018. Yet only four
intraocular slow release systems are approved today, due in part to the
challenges of matching new technologies with drug pharmacokinetics."
This workshop is one of the first to be held by the society that will
focus specifically on Ocular Drug Delivery. pSivida is also a sponsor of
The Controlled Release Society (CRS) is the premier international,
multidisciplinary society dedicated to delivery science and technology.
CRS serves members from industry, academia and government in more than
50 countries worldwide who have an interest in drug delivery and other
delivery applications in consumer and diversified products and animal
health. CRS provides innovative research, targeted networking and career
advancement to its membership.
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 treatments for
back-of-the-eye diseases. The most recent, ILUVIEN®, a micro-insert for
diabetic macular edema, is licensed to Alimera Sciences and 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, is
currently in pivotal phase III clinical trials with an NDA anticipated
in the first half of 2017. pSivida's preclinical development program is
focused on using its core platform technologies, Durasert™ and/or
Tethadur™, to deliver drugs and biologics to treat wet and dry
age-related macular degeneration (AMD), glaucoma, osteoarthritis and
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 statement 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: actual final IOP safety results for Medidur Phase III
trials; ability to achieve profitable operations and access to capital;
fluctuations in operating results; further impairment of intangible
assets; decline in Retisert royalties; successful commercialization of,
and receipt of revenues from, ILUVIEN for DME; effect of pricing and
reimbursement decisions on sales of ILUVIEN for DME; consequences of
fluocinolone acetonide side effects; number and cost of clinical trials
and data necessary to support an NDA for, approval by Indian regulators
of the trial design for, timing of filing the NDA for, and regulatory
approval and successful commercialization of, Medidur; delays in
completion of clinical trials; increases in cost of clinical trials;
changes in, or misunderstandings with respect to, FDA guidance on
required clinical trials; development of the Latanoprost Product and any
exercise by Pfizer of its option; ability of Tethadur to successfully
deliver large biologic molecules and to develop products using it;
ability to successfully develop product candidates, complete clinical
trials and receive regulatory approvals; ability to market and sell
products; success of current and future license agreements; termination
of 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 together with 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.
Follow pSivida on social media:
President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150721005842/en/
Martin E. Janis & Company, Inc.
Source: pSivida Corp.
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