TARRYTOWN, N.Y., Feb. 9, 2019 /PRNewswire/ --
Trial showed that early intervention with EYLEA improved
diabetic retinopathy severity and prevented serious
vision-threatening complications
EYLEA diabetic retinopathy sBLA target action date of
May 13, 2019
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced that positive detailed one-year
results from the Phase 3 PANORAMA trial evaluating
EYLEA® (aflibercept) Injection in patients with
moderately severe to severe non-proliferative diabetic retinopathy
(NPDR) were presented for the
first time at the Angiogenesis, Exudation, and Degeneration 2019
symposium.
The trial confirmed that moderately severe and severe
non-proliferative diabetic retinopathy is not a benign condition,
with patients at high risk of rapidly progressing to
vision-threatening events. In untreated patients with severe NPDR,
53% developed these events at one year. Most importantly, EYLEA
treatment prevented approximately 74% of these complications.
Key one-year data presented at the meeting are summarized
below:
|
Sham
Control
(N=133)
|
EYLEA
Every 16
Weeks
(N=135)
|
EYLEA
Every 8
Weeks
(N=134)
|
Primary
Endpoint
|
% of patients with
≥2‑step improvement on DRSS score from
baselinea
|
15%
|
65%a
|
80%a
|
Impact on
Vision-Threatening Events
|
Patients who
developed a vision-threatening eventb
|
41%
|
10%a
|
11%a
|
Subgroup with severe
NPDR at baseline (n=100)
|
53%
|
15%c
|
15%c
|
Subgroup with
moderately severe NPDR at baseline (n=302)
|
36%
|
8%d
|
10%d
|
DRSS=Diabetic Retinopathy Severity
Scale
a p<0.0001 versus
sham
b Vision-threatening events
defined as vision‑threatening complications (VTC; proliferative
diabetic retinopathy or anterior segment neovascularization) or
central‑involved diabetic macular edema
(CI-DME)
c Nominal p=0.0019 versus
sham
d Nominal p<0.0001 versus
sham
Topline one-year results from PANORAMA were previously
reported in October 2018.
"PANORAMA provides high-quality data to inform treatment of NPDR
without DME, as it is the first prospective trial involving these
high-risk patients since the landmark ETDRS trial of the 1980s when
laser was the only treatment option," said Charles C. Wykoff, M.D., Ph.D., PANORAMA
investigator, retina surgeon and ophthalmologist with Retina
Consultants of Houston. "Without
treatment, a large percentage of patients in the trial developed
proliferative disease and CI-DME in the first year. EYLEA treatment
reduced the risk of these events by approximately 74% compared to
sham injection, underscoring the potential importance of early
EYLEA anti-VEGF therapy. This efficacy was seen even with an every
16-week treatment regimen after loading doses, a management
approach that may realistically be achieved in the real world."
Adverse events were consistent with the known profile of EYLEA.
Serious ocular treatment-emergent adverse events in the study eye
occurred in 0 and 1 patients in the EYLEA treatment groups and 1
patient in the sham injection group. Ocular inflammation occurred
in 1 patient in each EYLEA treatment group and 0 patients in the
sham injection group. Anti-Platelet Trialists' Collaboration
(APTC)-defined arterial thromboembolic treatment-emergent events
occurred in 4 and 2 patients in the EYLEA treatment groups and 5
patients in the sham injection group.
A supplemental Biologics License Application (sBLA) for EYLEA in
diabetic retinopathy has been accepted for review by the U.S. FDA
with a target action date of May 13,
2019.
The safety and efficacy of EYLEA in diabetic retinopathy in
patients without DME have not been fully evaluated by any
regulatory authority.
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 in patients without
DME, compared to sham injections. Details on trial design
include:
- Three treatment arms – An observational sham injection
group and two EYLEA treatment groups. EYLEA was dosed every 8 weeks
(following five initial monthly doses) or every 16 weeks (following
three initial monthly doses and one 8-week interval).
- Primary endpoint – The primary endpoint was the
proportion of patients who experienced a two-step or greater
improvement in the DRSS from baseline for the combined EYLEA
treatment groups at week 24, and for each EYLEA treatment group
separately (every 8-week group and every 16-week group) at week 52.
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.
- Secondary endpoints – These include assessment of
whether EYLEA reduced VTCs (defined as proliferative diabetic
retinopathy and anterior segment neovascularization) or development
of CI-DME, as well as its impact on other anatomic effects, visual
acuity improvement, and safety.
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.
About Diabetic Retinopathy (DR)
Approximately eight
million people live with DR, 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 generally starts as NPDR and often has no warning signs or
symptoms. NPDR may progress to proliferative diabetic retinopathy
(PDR), a stage of the disease in which abnormal blood vessels grow
onto the surface of the retina and into the vitreous cavity
potentially causing severe vision loss.
DME can occur at any stage of DR as the blood vessels in the
retina become increasingly fragile and leak fluid, potentially
causing visual impairment. In the U.S., approximately 1.5 million
adults are diagnosed with DME, while approximately 3.5 million
people have DR without DME.
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 contraindicated in
patients with ocular or periocular infections, active intraocular
inflammation, or known hypersensitivity to aflibercept or to any of
the excipients in EYLEA.
- Intravitreal injections, including those with EYLEA, have been
associated with endophthalmitis and retinal detachments. Proper
aseptic injection technique must always be used when administering
EYLEA. Patients should be instructed to report any symptoms
suggestive of endophthalmitis or retinal detachment without delay
and should be managed appropriately. Intraocular inflammation has
been reported with the use of EYLEA.
- Acute increases in intraocular pressure have been seen within
60 minutes of intravitreal injection, including with EYLEA.
Sustained increases in intraocular pressure have also been reported
after repeated intravitreal dosing with VEGF inhibitors.
Intraocular pressure and the perfusion of the optic nerve head
should be monitored and managed appropriately.
- There is a potential risk of arterial thromboembolic events
(ATEs) following intravitreal use of VEGF inhibitors, including
EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial
infarction, or vascular death (including deaths of unknown cause).
The incidence of reported thromboembolic events in wet AMD studies
during the first year was 1.8% (32 out of 1824) in the combined
group of patients treated with EYLEA compared with 1.5% (9 out of
595) in patients treated with ranibizumab; through 96 weeks, the
incidence was 3.3% (60 out of 1824) in the EYLEA group compared
with 3.2% (19 out of 595) in the ranibizumab group. The incidence
in the DME studies from baseline to week 52 was 3.3% (19 out of
578) in the combined group of patients treated with EYLEA compared
with 2.8% (8 out of 287) in the control group; from baseline to
week 100, the incidence was 6.4% (37 out of 578) in the combined
group of patients treated with EYLEA compared with 4.2% (12 out of
287) in the control group. There were no reported thromboembolic
events in the patients treated with EYLEA in the first six months
of the RVO studies.
- Serious adverse reactions related to the injection procedure
have occurred in <0.1% of intravitreal injections with EYLEA
including endophthalmitis and retinal detachment.
- The most common adverse reactions (≥5%) reported in patients
receiving EYLEA were conjunctival hemorrhage, eye pain, cataract,
vitreous detachment, vitreous floaters, and intraocular pressure
increased.
INDICATIONS
EYLEA® (aflibercept) Injection
is indicated for the treatment of patients with Neovascular (Wet)
Age-related Macular Degeneration (AMD), Macular Edema following
Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and
Diabetic Retinopathy (DR) in patients with DME.
Please visit www.EYLEA.us to see the full Prescribing
Information for EYLEA.
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 seven
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.
Regeneron Forward-Looking Statements and Use of Digital
Media
This press 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; unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed
products, including without limitation any potential regulatory
approval of EYLEA for patients with diabetic retinopathy;
the impact of the recent and any potential future U.S. government
shutdowns on the anticipated timing of the decision by the U.S.
Food and Drug Administration regarding the supplemental Biologics
License Application for EYLEA in diabetic retinopathy referenced in
this press release; the extent to which the results from the
research and development programs conducted by Regeneron or its
collaborators may be replicated in other studies and lead to
therapeutic applications; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as EYLEA),
research and clinical programs, and business, including those
relating to patient privacy; 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; 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; the ability of Regeneron's
collaborators, suppliers, or other third parties to perform (as
applicable) manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; the availability and extent of reimbursement of
the Company's products (such as EYLEA) from third-party payers,
including private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its 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 EYLEA, Dupixent® (dupilumab)
Injection, and 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 U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2018. 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
Daren Kwok
Tel: +1 (914)
847-1328
daren.kwok@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914)
847-3482
mark.hudson@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.