Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
the first presentation of positive two-year (96 weeks) results from
the pivotal PULSAR trial investigating EYLEA® HD (aflibercept)
Injection 8 mg with 12- and 16-week dosing regimens, compared to
EYLEA® (aflibercept) Injection, in patients with wet
age-related macular degeneration (wAMD). The results were presented
with the 60-week results at the 23rd EURETINA Congress.
“EYLEA HD was approved in the U.S. based in part on strong
one-year efficacy and safety outcomes from PULSAR in wet
age-related macular degeneration,” said Charles C. Wykoff, M.D.,
Ph.D., Director of Research at Retina Consultants of
Texas and a trial investigator. “These two-year outcomes from
PULSAR show that EYLEA HD can deliver sustained and consistent
visual and anatomic benefits with extended dosing intervals in the
longer-term – helping to reduce the treatment burden for patients
with exudative retinal diseases and reinforcing the potential of
EYLEA HD as a new standard of care.”
PULSAR (N=1,009) is a double-masked, active-controlled pivotal
trial evaluating non-inferiority of EYLEA HD 12-week (n=335) and
16-week (n=338) dosing regimens compared to an 8-week dosing
regimen for EYLEA (n=336). All patients received three initial
monthly doses. Patients receiving EYLEA HD could have their dosing
intervals shortened to an every 8-week interval if protocol-defined
criteria for disease progression were observed. Patients were only
able to extend their dosing intervals in the second year by 4-week
increments up to 24-weeks, if pre-specified criteria were met.
The PULSAR trial met its primary endpoint, with EYLEA HD
patients achieving clinically equivalent vision gains to EYLEA at
48 weeks. As previously announced, EYLEA HD demonstrated
durable vision gains at extended dosing intervals at the end of two
years, with the mean number of injections administered being 9.7
for the 12-week EYLEA HD group, 8.2 for the 16-week EYLEA HD group,
and 12.8 for the EYLEA group. As presented at EURETINA, efficacy
results for EYLEA HD patients who completed the two-year follow-up
were as follows:
- Among all patients, 88% were on a ≥12-week dosing interval at
the end of two years, with 71% meeting the extension criteria for
≥16-week dosing intervals.
- Of patients assigned to ≥16-week dosing regimen at baseline,
78% were eligible for ≥16-week dosing at the end of two years, with
53% eligible for ≥20-dosing week intervals.
In PULSAR, the safety of EYLEA HD continued to be similar to
EYLEA through two years and remained consistent with the known
safety profile of EYLEA from previous clinical trials for wAMD.
There were no cases of occlusive retinal vasculitis or
endophthalmitis in the EYLEA HD groups. The rate of intraocular
inflammation was 1.3% for the aflibercept 8 mg group and 2.1% for
the EYLEA group. Anti-platelet trialists'
collaboration-defined arterial thromboembolic treatment-emergent
adverse events occurred in 1.8% of patients treated with
aflibercept 8 mg and 3.3% of patients treated with EYLEA.
The full EURETINA presentation is available on the Regeneron
website. The two-year data from the pivotal PHOTON trial for
aflibercept 8 mg in diabetic macular edema (DME) and diabetic
retinopathy (DR) were previously presented at the American
Society of Retina Specialists annual meeting in July 2023.
EYLEA HD is being jointly developed by Regeneron and Bayer AG.
In the U.S., Regeneron maintains exclusive rights to EYLEA and
EYLEA HD. Bayer has licensed the exclusive marketing rights outside
of the U.S., where the companies share equally the profits from
sales of EYLEA and EYLEA HD following any regulatory approvals.
About the EYLEA HD Clinical Trial ProgramPULSAR
in wAMD and PHOTON in DME/DR are double-masked, active-controlled
pivotal trials that are being conducted in multiple centers
globally. In both trials, patients were randomized into 3 treatment
groups to receive either: EYLEA HD every 12 weeks, EYLEA HD every
16 weeks, or EYLEA every 8 weeks. The lead sponsors of the trials
were Bayer for PULSAR and Regeneron for PHOTON.
Patients treated with EYLEA HD in both trials had 3 initial
monthly doses, and patients treated with EYLEA received 3 initial
doses in PULSAR and 5 in PHOTON. In the first year, patients in the
EYLEA HD groups could have their dosing intervals shortened down to
an every 8-week interval if protocol-defined criteria for disease
progression were observed. Intervals could not be extended until
the second year of the study. Patients in all EYLEA groups
maintained a fixed 8-week dosing regimen throughout their
participation in the trials.
About wAMD and Diabetic Eye DiseasewAMD is a
retinal disease that may affect people as they age. It occurs when
abnormal blood vessels grow and leak fluid under the macula, the
part of the eye responsible for sharp central vision and seeing
fine detail. This fluid can damage and scar the macula, which can
cause vision loss. An estimated 1.4 million Americans have
wAMD.
DR is an eye 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
nonproliferative diabetic retinopathy (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 6
million people have DR without DME.
About Ophthalmology at RegeneronAt Regeneron,
we relentlessly pursue groundbreaking innovations in eye care
science to help maintain the eye health of the millions of
Americans impacted by vision-threatening conditions. Over a decade
ago, our breakthrough scientific research resulted in the
development of EYLEA, a vascular endothelial growth factor (VEGF)
inhibitor designed to block the growth of new blood vessels and
decrease the ability of fluid to pass through blood vessels in the
eye. EYLEA has since brought fundamental change to the retinal
disease treatment landscape and is supported by a robust body of
research that includes eight pivotal Phase 3 trials, 11 years of
real-world experience, and more than 64 million EYLEA injections
globally.
Regeneron continues to advance our anti-angiogenesis expertise
with new solutions with the aim of offering optimal flexibility for
a broad group of patients and eye care professionals. This includes
EYLEA HD, which has been developed with the aim of extending the
time between injections, while maintaining the vision gains,
anatomic benefits and safety previously observed with EYLEA.
IMPORTANT SAFETY INFORMATION AND
INDICATIONS
INDICATIONSEYLEA HD (aflibercept) 8 mg is a
prescription medicine approved for the treatment of patients with
Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema
(DME), and Diabetic Retinopathy (DR).
EYLEA® (aflibercept) 2 mg is a prescription medicine approved
for the treatment of patients with Wet Age-Related Macular
Degeneration (AMD), Macular Edema following Retinal Vein Occlusion
(RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and
Retinopathy of Prematurity (ROP) (0.4 mg).
IMPORTANT SAFETY INFORMATION
- EYLEA HD and EYLEA are administered by injection into the eye.
You should not use EYLEA HD or 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 HD or EYLEA, including aflibercept.
- Injections into the eye with EYLEA HD or EYLEA can result in an
infection in the eye and retinal detachment (separation of retina
from back of the eye) can occur. Inflammation in the eye has been
reported with the use of EYLEA HD and EYLEA.
- In some patients, injections with EYLEA HD or 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.
- In infants with Retinopathy of Prematurity (ROP), treatment
with EYLEA will need extended periods of ROP monitoring.
- There is a potential but rare risk of serious and sometimes
fatal side effects, related to blood clots, leading to heart attack
or stroke in patients receiving EYLEA HD or EYLEA.
- The most common side effects reported in patients receiving
EYLEA HD were cataract, increased redness in the eye, increased
pressure in the eye, eye discomfort, pain, or irritation, blurred
vision, vitreous (gel-like substance) floaters, vitreous
detachment, injury to the outer layer of the eye, and bleeding in
the back of the eye.
- The most common side effects reported in patients receiving
EYLEA were increased redness in the eye, eye pain, cataract,
vitreous detachment, vitreous floaters, moving spots in the field
of vision, and increased pressure in the eye.
- The most common side effects reported in pre-term infants with
ROP receiving EYLEA were separation of the retina from the back of
the eye, increased redness in the eye, and increased pressure in
the eye. Side effects that occurred in adults are considered
applicable to pre-term infants with ROP, though not all were seen
in clinical studies.
- You may experience temporary visual changes after an EYLEA HD
or EYLEA injection and associated eye exams; do not drive or use
machinery until your vision recovers sufficiently.
- Contact your doctor right away if you think you or your baby
might be experiencing any side effects, including eye pain or
redness, light sensitivity, or blurring of vision, after an
injection.
- For additional safety information, please talk to your doctor
and see the full Prescribing Information for EYLEA HD and
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.
Please click here for full Prescribing Information
for EYLEA HD and
EYLEA.
About RegeneronRegeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to numerous FDA-approved treatments and
product candidates in development, almost all of which were
homegrown in our laboratories. Regeneron’s medicines and pipeline
are designed to help patients with eye diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, hematologic conditions, infectious diseases and rare
diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite®
technologies, such as VelocImmune®, which uses unique genetically
humanized mice to produce optimized fully human antibodies and
bispecific antibodies, and through ambitious research initiatives
such as the Regeneron Genetics Center®, which is conducting one of
the largest genetics sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn.
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
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“believe,” “seek,” “estimate,” variations of such words, and
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and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, “Regeneron’s Products”) and product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, “Regeneron’s Product Candidates”) and
research and clinical programs now underway or planned, including
without limitation EYLEA® HD™ (aflibercept) Injection 8 mg for the
treatment of patients with wet age-related macular degeneration,
diabetic macular edema, and diabetic retinopathy; uncertainty of
the utilization, market acceptance, and commercial success of
Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product
Candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary), including
the studies discussed or referenced in this press release, on any
of the foregoing; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron’s Product
Candidates and new indications for Regeneron’s Products; the
ability of Regeneron’s collaborators, licensees, suppliers, or
other third parties (as applicable) to perform manufacturing,
filling, finishing, packaging, labeling, distribution, and other
steps related to Regeneron’s Products and Regeneron’s Product
Candidates; the ability of Regeneron to manage supply chains for
multiple products and product candidates; safety issues resulting
from the administration of Regeneron’s Products and Regeneron’s
Product Candidates in patients, including serious complications or
side effects in connection with the use of Regeneron’s Products and
Regeneron’s Product Candidates in clinical trials; 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 Regeneron’s Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron’s Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron’s Products (such as EYLEA HD)
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;
competing drugs and product candidates that may be superior to, or
more cost effective than, Regeneron’s Products and Regeneron’s
Product Candidates; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
collaborators or licensees may be replicated in other studies
and/or lead to advancement of product candidates to clinical
trials, therapeutic applications, or regulatory approval;
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, collaboration, or supply agreement, including Regeneron’s
agreements with Sanofi and Bayer (or their respective affiliated
companies, as applicable) to be cancelled or terminated; the impact
of public health outbreaks, epidemics, or pandemics (such as the
COVID-19 pandemic) on Regeneron's business; and risks associated
with intellectual property of other parties and pending or future
litigation relating thereto (including without limitation the
patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection 2 mg and REGEN-COV®
(casirivimab and imdevimab)), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations, the ultimate outcome of any such proceedings
and investigations, 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, 2022 and its Form 10-Q for the
quarterly period ended June 30, 2023. 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 or otherwise) any
forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
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Contacts:Media RelationsMary
HeatherTel: +1 914-847-8650mary.heather@regeneron.com |
Investor
RelationsMark HudsonTel: +1
914-847-3482mark.hudson@regeneron.com |
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