Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the
presentation of positive long-term results and subgroup analyses
from the pivotal clinical program of EYLEA® HD (aflibercept)
Injection 8 mg. The presentations are part of 14 accepted abstracts
on EYLEA HD and EYLEA® (aflibercept) Injection 2 mg that will be
shared at the Association for Research in Vision and Ophthalmology
(ARVO) annual meeting from May 5 to 9 in Seattle.
“Our extensive data presentations at ARVO showcase the
differentiated efficacy, safety and durability of EYLEA HD, and
demonstrate our commitment to advancing retinal care for patients
who are at risk of losing vision,” said Boaz Hirshberg, M.D.,
Senior Vice President, Clinical Development, Internal Medicine at
Regeneron. “Since its FDA approval, we have seen growing use and
positive patient and physician experiences with EYLEA HD in both
treatment-experienced and treatment-naïve patients. The ARVO
presentations highlight the encouraging real-world impact of EYLEA
HD seen so far and reinforce its potential as a new
standard-of-care for people living with wet age-related macular
degeneration, diabetic macular edema and diabetic retinopathy.”
Notable podium presentations at ARVO include:
- One-year (48 week) data from the PHOTON trial investigating
EYLEA HD in diabetic macular edema (DME) patients with or without
prior treatment, compared to EYLEA.
- Two-year (96 week) results from the PULSAR trial investigating
EYLEA HD in patients with wet age-related macular degeneration
(wAMD), compared to EYLEA, which will feature a post-hoc analysis
on the correlation of key baseline disease characteristics in wAMD
to dosing intervals of EYLEA HD.
- A PULSAR subgroup analysis evaluating visual and anatomic
improvements with EYLEA HD, compared to EYLEA, based on baseline
best corrected visual acuity (BCVA), corneal refractive therapy
(CRT), choroidal neovascularization (CNV) type and race.
In addition, a population pharmacokinetics analysis will be
presented to elucidate the observed extended durability of EYLEA HD
compared to EYLEA. These data provide a biological rationale for
the approved extended dosing regimens of EYLEA HD.
The most common adverse reactions (≥3%) reported in patients
treated with EYLEA HD were cataract, conjunctival hemorrhage,
intraocular pressure increased, ocular discomfort/eye pain/eye
irritation, vision blurred, vitreous floaters, vitreous
detachment, corneal epithelium defect, and retinal
hemorrhage.
EYLEA HD (known as Eylea™ 8 mg in the European Union and other
ex-US countries) is being jointly developed by Regeneron and Bayer
AG. In the U.S., Regeneron maintains exclusive rights to EYLEA HD
and EYLEA. Bayer has licensed the exclusive marketing rights
outside of the U.S., where the companies share equally the profits
from sales of EYLEA HD and EYLEA following any regulatory
approvals.
EYLEA HD and EYLEA presentations at ARVO:
Abstract title |
Abstract |
Lead author |
Presentation date, time (PST), location |
EYLEA HD |
Week 48 outcomes in aflibercept 8 mg- and 2 mg-treated patients by
prior DME treatment status: a subgroup analysis of the Phase 2/3
PHOTON trial |
#4887Podium Presentation |
Nitish Mehta, M.D. |
Wednesday, May 83:45 – 4:00 PM6E - Arch Building |
BCVA gains with aflibercept 8 mg maintained through Week 96 in
PULSAR with extended treatment intervals in patients with
nAMD* |
#2115Podium Presentation |
Sobha Sivaprasad, M.D. |
Monday, May 63:30 – 3:45 PM6E, Arch Building |
Key baseline disease characteristics in nAMD are not linked to
treatment interval extension of aflibercept 8 mg: A post-hoc
96-week PULSAR analysis* |
#2116Podium Presentation |
Justus G. Garweg, M.D. |
Monday, May 63:45 – 4:00 PM6E, Arch Building |
A 96-week PULSAR subgroup analysis: Similar visual and anatomic
improvements with aflibercept 8 mg every 12 weeks or longer and 2
mg every 8 weeks, as defined by baseline BCVA, CRT, CNV type, and
race* |
#4906Podium Presentation |
Richard Gale, M.D. |
Wednesday, May 83:15 – 3:30 PM612, Arch Building |
Population pharmacokinetic modeling and simulation of ocular
clearance for aflibercept 8 mg and 2 mg and association with
durability of effect |
#A0441Poster Presentation |
Peter K. Kaiser, M.D. |
Tuesday, May 78:30 – 10:15 AMExhibit Hall |
Impact of baseline central retinal thickness (CRT) on vision among
patients with diabetic macular edema (DME): post hoc analysis of
the Phase 2/3 PHOTON trial |
#B0129Poster Presentation |
Deepak Sambhara, M.D. |
Thursday, May 911:45 AM – 1:30 PMExhibit Hall |
Intraocular pressure outcomes with intravitreal injection of
aflibercept 8 mg and 2 mg in patients with diabetic macular edema
through Week 48 of the Phase 2/3 PHOTON trial |
#B0130Poster Presentation |
Mark R. Barakat, M.D. |
Thursday, May 911:45 AM – 1:30 PMExhibit Hall |
Outcomes of patients with diabetic macular edema (DME) and baseline
best-corrected visual acuity (BCVA) of 20/50 or worse or 20/40 or
better who were treated with aflibercept 8 mg and 2 mg: a post hoc
analysis of the Phase 2/3 PHOTON trial |
#B0148Poster Presentation |
Sean Adrean, M.D. |
Thursday, May 911:45 AM – 1:30 PMExhibit Hall |
Pooled safety analysis of the CANDELA, PHOTON, and PULSAR trials up
to 96 weeks demonstrates comparable safety profiles with
aflibercept 8 mg and 2 mg* |
#B0280Poster Presentation |
Andreas Stahl, M.D. |
Sunday, May 58:00 – 9:45 AMExhibit Hall |
Aflibercept 8 mg monotherapy shows maintained efficacy over 96
weeks, with the ability to extend dosing intervals beyond every 16
weeks, in patients with PCV in the PULSAR Phase 3 trial* |
#B0282Poster Presentation |
Rufino Silva, M.D. |
Sunday, May 58:00 – 9:45 AMExhibit Hall |
Comparable efficacy with aflibercept 8 mg at extended dosing
intervals beyond q16 versus 2 mg q8 in Asian patients with nAMD in
PULSAR through Week 96* |
#B0283Poster Presentation |
Xiaodong Sun, M.D. |
Sunday, May 58:00 – 9:45 AMExhibit Hall |
EYLEA |
Baseline (BL) factors associated with no improvement in Diabetic
Retinopathy Severity Scale (DRSS) Score in sham patients from
PANORAMA over 2 years |
#4928Podium Presentation |
Anita Barikian, M.D. |
Wednesday, May 82:15 – 2:30 PMYakima 1, Arch Building |
Outcomes of retinal neurodegenerative changes in patients with
diabetic macular edema from the VISTA study |
#B0170Poster Presentation |
Mustafa Iftikhar, M.D. |
Thursday, May 911:45 AM – 1:30 PMExhibit Hall |
Impact of exposure to residual intraretinal fluid and fluctuations
of central subfield thickness on visual outcomes in eyes with
macular edema following central retinal vein occlusion: A 1-year
post hoc analysis of the COPERNICUS and GALILEO trials |
#B0369Poster Presentation |
Michael S. Ip, M.D. |
Sunday, May 5 1:00 – 2:45 PMExhibit Hall |
*Bayer-run trial
About the EYLEA HD Clinical Trial Program
PULSAR in wAMD and PHOTON in DME 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. One-year results from the
PULSAR and PHOTON trials were recently published in
The Lancet.
Two-year data from the pivotal PULSAR trial were originally
presented at the EURETINA Congress in October 2023, and two-year
data from the pivotal PHOTON trial were first presented at the
American Society of Retina Specialists annual meeting in July
2023.
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 Disease wAMD 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 Regeneron At 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
INDICATIONS
EYLEA® 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 over 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. Our
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
MediaThis 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 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 and
EYLEA® (aflibercept) Injection 2 mg; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron’s Products (such as EYLEA HD and EYLEA) 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
and 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; 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), 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, 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
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 (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
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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