pSivida earns $25 million milestone
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 that the U.S. Food and Drug Administration (FDA) has
approved ILUVIEN® for the treatment of diabetic macular edema (DME). It
is indicated for patients who have been previously treated with a course
of corticosteroids and did not have a clinically significant rise in
intraocular pressure (IOP). A single injection of the ILUVIEN
micro-insert provides sustained treatment of DME for 36 months.
Approximately 560,000 people in the U.S. are estimated to have
clinically significant DME, the most frequent cause of vision loss in
individuals with diabetes and the leading cause of blindness in young
and middle-aged adults in developed countries. ILUVIEN is expected to be
commercially available in the U.S. in early 2015.
FDA approval of ILUVIEN entitles pSivida to a $25 million milestone from
its licensee Alimera Sciences. pSivida will also be entitled to 20% of
the net profits from sales of ILUVIEN in the U.S.
"FDA approval of ILUVIEN, our third FDA-approved product for retinal
disease, provides an important treatment option for DME patients in the
U.S., the majority of whose DME, despite anti-VEGF intra-ocular
injections as frequently as monthly, is not optimally managed. ILUVIEN's
clinical trials showed that ILUVIEN can actually reverse vision loss in
many DME patients. Another advantage of ILUVIEN over existing therapies
is that a single injection provides sustained therapy for three years,"
said Paul Ashton, Ph.D., president and chief executive officer of
pSivida.
"The $25 million milestone will help finance our ongoing product
development program, including Medidur™ for posterior uveitis and
Tethadur™ for the sustained delivery of biologics," added Dr. Ashton.
pSivida is independently developing Medidur, an injectable, sustained
release micro-insert of the same design and delivering the same drug as
ILUVIEN, for the treatment of chronic posterior uveitis, the third
largest cause of blindness in the U.S. The Company plans to seek FDA
approval of this product on the basis of its ongoing single Phase III
clinical trial. Enrollment of this study is expected to be completed by
the end of the first quarter of calendar 2015.
ILUVIEN is already commercially available in the U.K. and Germany, and
has received or is pending marketing approval in seventeen other EU
countries, for the treatment of patients with the chronic DME
insufficiently responsive to available therapies. "We are very pleased
that the FDA's approval of ILUVIEN is not limited, as in the EU, to the
subset of patients with chronic DME, patients who have failed other
therapies, or patients who have had cataract surgery," continued Dr.
Ashton.
ILUVIEN is an injectable micro-insert that provides sustained treatment
through continuous delivery of a submicrogram dose of the corticosteroid
fluocinolone acetonide for 36 months. Current standard-of-care therapy
requires anti-VEGF injections into the eye as frequently as monthly, and
studies show that over 50 percent of patients are not optimally managed
with this treatment. FDA approval was based on clinical trial data that
showed that at month 24, 28.7 percent of patients receiving ILUVIEN
experienced an improvement from baseline in their best corrected visual
acuity on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye
chart of 15 letters or more. This improvement in vision was maintained
through 36 months, the end of the trials.
About ILUVIEN®
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is a
sustained release intravitreal implant approved in the United States to
treat DME in patients who have been previously treated with a course of
corticosteroids and did not have a clinically significant rise in
intraocular pressure. Each ILUVIEN implant is designed to release
submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid
for 36 months.
Corticosteroids have a history of effective use in treating ocular
disease inflammation. ILUVIEN is injected in the back of the patient's
eye with an applicator that employs a 25-gauge needle, which allows for
a self-sealing wound. In the FAME™ Study, a phase 3 clinical study of
ILUVIEN, the most frequently reported adverse drug reactions included
cataract development and increased ocular pressure.
ILUVIEN Important Safety Information
ILUVIEN contains a corticosteroid and is indicated for the treatment of
DME in patients who have been previously treated with a course of
corticosteroids and did not have a clinically significant rise in
intraocular pressure.
Intravitreal injections have been associated with endophthalmitis, eye
inflammation, increased intraocular pressure, and retinal detachments.
Patients should be monitored following the injection.
Use of corticosteroids may produce posterior subcapsular cataracts,
increased intraocular pressure, glaucoma, and may enhance the
establishment of secondary ocular infections due to bacteria, fungi, or
viruses.
The implant may migrate into the anterior chamber if the posterior lens
capsule is not intact. In controlled studies, the most common adverse
reactions reported were cataract development and increases in
intraocular pressure.
Patients are advised to have follow-up eye examinations at appropriate
intervals following treatment with ILUVIEN. Full prescribing information
will be available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
About DME
Diabetic Macular Edema, the primary cause of vision loss associated with
diabetic retinopathy, is a disease affecting the macula, the part of the
retina responsible for central vision. When the blood vessel leakage of
diabetic retinopathy causes swelling in the macula, the condition has
progressed to DME. The onset of DME is painless and may go undetected by
the patient until it manifests with the blurring of central vision or
acute vision loss. The severity of this blurring may range from mild to
profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic
Retinopathy found that over a 10-year period approximately 19 percent of
people with diabetes studied were diagnosed with DME. All people with
type 1 or type 2 diabetes are at risk of developing DME. As the
population of people with diabetes increases, the annual incidence of
diagnosed DME is expected to increase, as well.
Duration of diabetes is the greatest risk factor for increased
retinopathy and is associated with an increased prevalence of DME. The
appearance of retinopathy is associated with an up-regulation of
vascular endothelial growth factor (VEGF) causing an increase in
permeability of vessels leading to leakage of fluid. As retinopathy
worsens, an up-regulation of multiple cytokines (inflammatory factors)
takes place. Corticosteroids offer a broad effect on down regulation of
multiple cytokines associated with DME that persists.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, is a leader in the
development of sustained release, drug delivery products for treating
eye diseases. 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 a
pivotal Phase III clinical trial of its lead product candidate, Medidur™
for treatment of the chronic, back-of-the-eye disease posterior uveitis.
Medidur uses the same injectable, sustained release micro-insert as
pSivida's lead licensed product, ILUVIEN® for the treatment of DME,
licensed to Alimera Sciences, Inc. In the EU, ILUVIEN is marketed in the
U.K. and Germany and has received or is pending marketing authorization
in seventeen EU for the treatment of chronic DME considered
insufficiently responsive to available therapies. In the U.S., ILUVIEN
has been approved for the treatment of DME in patients who have
previously completed a course of therapy with a steroid without
experiencing a clinically significant increase in IOP. pSivida's
FDA-approved Retisert®, an implant which provides long-term, sustained
drug delivery to treat posterior uveitis, is licensed to and sold by
Bausch & Lomb Incorporated. pSivida's preclinical research is focused on
ocular and systemic delivery of biologics and treatment of wet and dry
age-related macular degeneration, osteoarthritis and glaucoma.
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: ; Alimera's
ability to fund the $25 million milestone and to finance, successfully
commercialize and achieve market acceptance of, and generate revenues to
pSivida from, ILUVIEN for DME in the U.S.; timing of commencement of
sales of ILUVIEN in the U.S.; 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; pSivida's ability to finance, complete and achieve a successful
clinical outcome for its clinical trials of, 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 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
For more information on pSivida, visit www.psivida.com.
In US:
Martin E. Janis & Company, Inc.
Beverly
Jedynak
President
+1 312 943 1123
M: +1 773 350 5793
bjedynak@janispr.com
Source: pSivida Corp.
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