pSivida CEO to Speak at Controlled Release Society Annual Meeting Workshop in Edinburgh, Scotland, This Weekend
21 July 2015 - 10:45PM
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 workshop.
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 other diseases.
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:
Twitter: https://twitter.com/pSividaCorpFacebook:
https://www.facebook.com/pages/PSivida-Corp/544893792199562LinkedIn:
http://www.linkedin.com/company/psividaGoogle+:
https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/postsThe
President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20150721005842/en/
Martin E. Janis & Company, Inc.Beverly JedynakPresidentT:
312-943-1123M: 773-350-5793bjedynak@janispr.com
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