Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The
Lancet published one-year results from the pivotal PULSAR and
PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg.
Specifically, the publications detailed data demonstrating that
EYLEA HD extended dosing regimens were non-inferior to EYLEA®
(aflibercept) Injection 2 mg for both the treatment of wet
age-related macular degeneration (wAMD) and diabetic macular edema
(DME).
“The publication of 48-week results from PULSAR and PHOTON in
The Lancet are a recognition of the important advancement EYLEA HD
has made in retinal care,” said David M. Brown, M.D., FACS,
Director of Research at Retina Consultants of Texas and a trial
investigator. “Less than a year after its approval, EYLEA HD has
already made an impact in the treatment of wet age-related macular
degeneration and diabetic macular edema. EYLEA HD has provided
disease control for my tough-to-treat cases of diabetic eye disease
and allowed both my diabetic and wet age-related macular
degeneration patients to enjoy less frequent dosing with a similar
safety profile to EYLEA.”
PULSAR and PHOTON are two double-masked, active-controlled
pivotal trials evaluating EYLEA HD compared to EYLEA. As published
in The Lancet, both PULSAR in wAMD (N=1,009) and PHOTON in DME
(N=658) met their primary endpoints, with EYLEA HD demonstrating
non-inferior and clinically equivalent vision gains at 48 weeks
with both 12- and 16-week dosing regimens after only 3 initial
monthly doses, compared to an EYLEA 8-week dosing regimen after
initial monthly doses (3 in PULSAR and 5 in PHOTON). Furthermore,
79% and 77% of wAMD patients and 91% and 89% of DME patients, who
were respectively randomized to 12- and 16-week dosing, maintained
these extended dosing intervals through 48 weeks.
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.
In August 2023, EYLEA HD was approved by the U.S. Food and Drug
Administration for the treatment of patients with wAMD, DME and
diabetic retinopathy (DR) based on the one-year data. Two-year data
were presented in 2023 for PULSAR at the EURETINA Congress and for
PHOTON at the American Society of Retina Specialists annual
meeting.
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 (known as Eylea 8 mg outside the U.S.).
Eylea 8 mg is approved in the European Union, Japan and other
countries. Submissions to other regulatory authorities in
additional countries have been made.
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.
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) Injection 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) Injection 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, retinal detachment (separation of retina from
back of the eye) and, more rarely, serious inflammation of blood
vessels in the retina that may include blockage. Call your doctor
right away if you or your baby (if being treated with EYLEA for
Retinopathy of Prematurity) experience eye pain or redness, light
sensitivity, or a change in vision after an injection.
- 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.
- 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 for the
treatment of patients with wet age-related macular degeneration and
diabetic macular edema; 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) 2 mg Injection), 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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