Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
long-term outcomes and new analyses of pivotal clinical data for
EYLEA® HD (aflibercept) Injection 8 mg will be presented at the
American Academy of Ophthalmology (AAO) annual meeting in San
Francisco from November 3 to 6.
“Following the approval of EYLEA HD, we have continued to
evaluate data from the pivotal clinical program to identify new
insights that may support physicians in administering this
innovative treatment to patients living with certain serious
retinal diseases,” said Boaz Hirshberg, M.D., Senior Vice
President, Clinical Development, Internal Medicine at Regeneron.
“At this year’s AAO, we will present a wide-ranging review of
results from the PULSAR and PHOTON trials in wet age-related
macular degeneration and diabetic macular edema. Together, they
showcase the impressive durability and consistent safety profile of
EYLEA HD over the long-term across different extended dosing
intervals and patient characteristics.”
Notable presentations include a detailed review of positive
two-year (96 weeks) results from the pivotal PULSAR and PHOTON
trials investigating EYLEA HD with 12- and 16-week dosing regimens,
compared to EYLEA® (aflibercept) Injection 8-week dosing
regimens, in patients with wet age-related macular degeneration
(wAMD) and diabetic macular edema (DME), respectively.
Additionally, subgroup data from PHOTON in DME across sex, age,
race and ethnicity will be presented, as well as a pooled safety
analysis from the PULSAR, PHOTON and Phase 2 CANDELA trials.
Two-year data from the pivotal PULSAR trial were previously
presented at the EURETINA Congress in October 2023. Two-year data
from the pivotal PHOTON trial were previously presented at
the American Society of Retina Specialists (ASRS) annual
meeting in July 2023.
EYLEA HD (known as aflibercept 8 mg outside of the U.S.) 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.
EYLEA HD and EYLEA presentations at AAO:
Abstract title |
Session |
Lead author |
Presentation date, time (PST), location |
EYLEA HD |
Aflibercept 8mg for Diabetic Macular Edema: 96-Week Results of the
PHOTON Study |
RET11Podium Presentation |
Diana V. Do, M.D. |
Friday, November 3 5:02 – 5:08 PMWEST 3004 |
Aflibercept 8 mg in Patients With Neovascular AMD: Phase 3 PULSAR
Trial 96-Week Results* |
RET10Podium Presentation |
Jean-Francois Korobelnik, M.D. |
Friday, November 3 4:13 – 4:18 PMWEST 3004 |
Intravitreal Aflibercept 8 mg for DME: Week 48 Efficacy Outcomes by
Baseline Demographics in the Phase 2/3 PHOTON Trial |
PA025Podium Presentation |
Sean Adrean, M.D. |
Sunday, November 5 8:00 – 8:07 AMWEST 2006 |
Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON
and PULSAR Trials |
PO551ePoster |
Veeral Sheth, M.D. |
Available on demand |
Characteristics of Patients Who Did or Did Not Maintain Aflibercept
8-mg Dosing Intervals in the Phase 2/3 PHOTON Trial |
PO519ePoster |
Dennis M. Marcus, M.D. |
Available on demand |
Intravitreal Aflibercept 8 mg in Patients With PCV: PULSAR Subgroup
Analysis* |
PO508ePoster |
Timothy Y. Lai, M.D., FRCOphth, FRCS |
Available on demand |
Intravitreal Aflibercept 8-mg Injection in Patients With nAMD:
Subgroup Analyses From the Phase 3 PULSAR Trial* |
PO512ePoster |
David A. Eichenbaum, M.D. |
Available on demand |
Early Fluid Resolution Association With Treatment Interval
Maintenance at Week 48 in Patients Receiving Aflibercept 8 mg:
Phase 3 PULSAR Trial* |
PO474ePoster |
Varun Chaudhary, M.D. |
Available on demand |
EYLEA |
Two-Year Outcomes From FIREFLEYE Next, a Prospective Long-Term
Follow-Up Study After Treatment of ROP With Aflibercept vs.
Laser* |
PA021Podium Presentation |
Andreas Stahl, M.D. |
Saturday, November 44:09 – 4:16 PMWEST 2006 |
*Bayer-run trial
About the EYLEA HD Clinical Trial ProgramPULSAR
in wAMD and PHOTON in DME/diabetic retinopathy (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.
CANDELA was a Regeneron-sponsored Phase 2 trial investigating
the safety and efficacy of EYLEA HD extended dosing regimens
compared to EYLEA in wAMD patients.
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 70 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
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Inc. (“Regeneron” or the “Company”), and actual events or
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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
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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
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year ended December 31, 2022 and its Form 10-Q for the
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Contacts: |
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Media RelationsMary HeatherTel: +1
914-847-8650mary.heather@regeneron.com |
Investor RelationsMark HudsonTel: +1
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