TARRYTOWN, N.Y., March 19, 2018 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the Phase 3 PANORAMA trial evaluating EYLEA®
(aflibercept) Injection in moderately severe to severe
non-proliferative diabetic retinopathy (NPDR) met its 24-week
primary endpoint. In the trial, 58 percent of EYLEA-treated
patients experienced a two-step or greater improvement from
baseline on the Diabetic Retinopathy Severity Scale (DRSS) at week
24, compared to 6 percent of patients receiving sham injection
(p<0.0001).
"This is the first time a therapy has demonstrated it can
reverse disease progression in patients with moderately severe to
severe non-proliferative diabetic retinopathy without diabetic
macular edema, in a trial specifically designed to study this
population," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. "Patients in the trial continue to be
evaluated to determine if EYLEA can prevent progression to
neovascular vision-threatening complications or diabetic macular
edema. We look forward to sharing one-year results later this
year."
Patients in the active treatment groups received, on average,
4.4 EYLEA injections during the first 24 weeks. There were no new
safety signals in the trial. There was one case of mild intraocular
inflammation (IOI) in a patient treated with EYLEA (0.085 percent
rate per injection), which is consistent with the rate of IOI seen
in previous clinical trials.
About the PANORAMA trial
PANORAMA is an ongoing,
pivotal, double-masked, randomized two-year trial that enrolled 402
patients and is designed to investigate EYLEA for the improvement
of moderately severe to severe NPDR without diabetic macular edema
(DME), compared to sham injection. Details on trial design
include:
- Three treatment arms – An observational sham
injection group and two EYLEA treatment groups. The EYLEA treatment
groups started with either three or five initial monthly doses, and
the trial will evaluate every eight-week dosing or every 16-week
dosing at one year.
- Two primary endpoints – Both assess the proportion of
patients who experience a two-step or greater improvement in DRSS
score from baseline. The first is measured at six months (24 weeks)
and the second at one year (52 weeks). The DRSS is a systematic
grading scale to assess the severity of diabetic retinopathy based
on photographs of the retina following a dilated eye exam.
- Key secondary endpoints – These include assessment of
whether EYLEA prevents neovascular vision-threatening complications
(such as progression to proliferative diabetic retinopathy (PDR)
and anterior segment neovascularization) or progression to DME, as
well as its impact on other anatomic effects, visual acuity
improvement, and safety. Some secondary endpoints will be measured
for up to two years.
Results from PANORAMA will be submitted for presentation at a
future medical congress. PANORAMA will also form the basis of a
supplemental Biologics License Application (sBLA) to the U.S. Food
and Drug Administration later this year.
A separate ongoing trial sponsored by the Diabetic Retinopathy
Clinical Research Network known as Protocol W is also evaluating
EYLEA for the treatment of NPDR in patients without DME.
The safety and efficacy of the potential use of EYLEA in
moderately severe to severe NPDR in patients without DME have not
been fully evaluated by any regulatory authority.
About Diabetic Retinopathy
Approximately eight million
people live with diabetic retinopathy, a disease characterized by
microvascular damage to the blood vessels in the retina often
caused by poor blood sugar control in people with diabetes. The
disease starts as NPDR and generally has no warning signs or
symptoms. Approximately 560,000 people live with moderately severe
to severe NPDR without DME in the U.S. As NPDR becomes more severe,
DME can occur as the blood vessels in the retina become
increasingly fragile and leak fluid, potentially causing visual
impairment. NPDR may also progress to PDR, a stage of the disease
in which abnormal blood vessels grow onto the surface of the retina
and potentially cause severe, vision-threatening complications such
as vitreous hemorrhage and traction retinal detachment.
About EYLEA® (aflibercept)
Injection
EYLEA® (aflibercept) Injection is a
vascular endothelial growth factor (VEGF) inhibitor formulated as
an injection for the eye. It is designed to block the growth of new
blood vessels and decrease the ability of fluid to pass through
blood vessels (vascular permeability) in the eye by blocking VEGF-A
and placental growth factor (PLGF), two growth factors involved in
angiogenesis. In the U.S., EYLEA is the market-leading,
FDA-approved anti-VEGF treatment for its approved indications and
is supported by a robust body of research that includes seven
pivotal Phase 3 trials.
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept)
INJECTION
EYLEA® (aflibercept) Injection is a
prescription medication administered by injection into the eye. You
should not use EYLEA if you have an infection in or around the eye,
eye pain or redness, or known allergies to any of the ingredients
in EYLEA, including aflibercept.
Injection into the eye with EYLEA can result in an infection in
the eye and retinal detachment (separation of retina from back of
the eye). Inflammation in the eye has been reported with the use of
EYLEA.
In some patients, injections with EYLEA may cause a temporary
increase in eye pressure within 1 hour of the injection. Sustained
increases in eye pressure have been reported with repeated
injections, and your doctor may monitor this after each
injection.
There is a potential risk of serious and sometimes fatal side
effects related to blood clots, leading to heart attack or stroke
in patients receiving EYLEA.
Serious side effects related to the injection procedure with
EYLEA are rare but can occur including infection inside the eye and
retinal detachment.
The most common side effects reported in patients receiving
EYLEA are increased redness in the eye, eye pain, cataract, moving
spots in the field of vision, increased pressure in the eye, and
vitreous (gel-like substance) detachment.
It is important that you contact your doctor right away if you
think you might be experiencing any side effects, including eye
pain or redness, light sensitivity, or blurring of vision, after an
injection.
EYLEA is for prescription use only. For additional safety
information, please talk to your doctor and see the full
Prescribing Information for EYLEA.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
INDICATIONS
EYLEA® (aflibercept) Injection is a
prescription medicine approved for the treatment of patients
with:
Wet Age-related Macular Degeneration (AMD): The recommended dose
for EYLEA is 2 mg administered by injection in the eye every 2
months (8 weeks) following 3 initial monthly (every 4 weeks)
injections. EYLEA may be dosed once per month, but in most
patients, additional benefit was not seen with this dosing plan.
Some patients may need monthly (every 4 weeks) dosing after the
first 3 months (12 weeks).
Macular Edema following Retinal Vein Occlusion (RVO): The
recommended dose for EYLEA is 2 mg administered by injection in the
eye monthly (every 4 weeks).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in
patients with DME: The recommended dose for EYLEA is 2 mg
administered by injection in the eye every 2 months (8 weeks)
following 5 initial monthly (every 4 weeks) injections. EYLEA may
be dosed once per month, but in most patients, additional benefit
was not seen with this dosing plan. Some patients may need monthly
(every 4 weeks) dosing after the first 5 months (20 weeks).
Please visit www.EYLEA.us to see the full Prescribing
Information for EYLEA.
The information contained herein is provided for general
educational purposes. If you have any questions, talk to your
doctor.
About Regeneron Pharmaceuticals,
Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology
company that invents life-transforming medicines for people with
serious diseases. Founded and led for 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to six
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
disease, heart disease, allergic and inflammatory diseases, pain,
cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This news release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
EYLEA® (aflibercept) Injection; the likelihood, timing,
and scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for
marketed products, such any potential regulatory approval of EYLEA
for moderately severe to severe non-proliferative diabetic
retinopathy (including any potential approval by the U.S. Food and
Drug Administration based on the planned supplemental Biologics
License Application referenced in this news release); the extent to
which the results from the research and development programs
conducted by Regeneron or its collaborators (including the 24-week
primary endpoint results from the Phase 3 PANORAMA trial reported
in this news release) may be replicated in the future and lead to
therapeutic applications; unforeseen safety issues and possible
liability resulting from the administration of products and product
candidates in patients, including without limitation EYLEA; serious
complications or side effects in connection with the use of
Regeneron's products and product candidates in clinical trials,
such as the Phase 3 PANORAMA trial discussed in this news release;
coverage and reimbursement determinations by third-party payers,
including Medicare, Medicaid, and pharmacy benefit management
companies; ongoing regulatory obligations and oversight impacting
Regeneron's marketed products, research and clinical programs, and
business, including those relating to the enrollment, completion,
and meeting of the relevant endpoints of post-approval studies;
determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to
continue to develop or commercialize Regeneron's products and
product candidates, such as EYLEA; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
products and product candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its sales or other financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license or
collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), to be cancelled or
terminated without any further product success; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto, including without limitation
the patent litigation proceedings relating to Praluent®
(alirocumab) Injection, the ultimate outcome of any such litigation
proceedings, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the United States
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2017. Any
forward-looking statements are made based on management's current
beliefs and judgment, and the reader is cautioned not to rely on
any forward-looking statements made by Regeneron. Regeneron does
not undertake any obligation to update publicly any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Contacts Regeneron:
Media Relations
Sarah Cornhill
Tel: +1 (917) 297-1522
sarah.cornhill@regeneron.com
Investor Relations
Manisha Narasimhan, Ph.D.
Tel: +1 (914) 847-5126
manisha.narasimhan@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.