Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
positive, two-year (96 weeks), topline data from the pivotal PULSAR
trial investigating aflibercept 8 mg in patients with wet
age-related macular degeneration (wAMD). During the trial,
aflibercept 8 mg patients were initially randomized to either 12-
or 16-week dosing intervals (after three initial monthly doses) and
were able to shorten or extend dosing intervals if pre-specified
criteria were met. The longer-term data follow the positive
two-year results for PHOTON with diabetic macular edema (DME),
with PULSAR similarly demonstrating that the vast majority of
aflibercept 8 mg patients with wAMD were able to maintain or
further extend their dosing intervals. Among those who completed
the two-year follow-up:
- 88% were on a ≥12-week dosing interval at the end of two
years.
- 78% maintained ≥12-week dosing intervals throughout the
two-year study period, compared to 83% throughout the first year of
study (48 weeks).
- 71% met the extension criteria for even longer dosing
intervals, including 47% for ≥20-week intervals and 28% for 24-week
intervals.
- Of those assigned to ≥16-week dosing regimen at baseline, 70%
maintained ≥16-week dosing intervals throughout the two-year study
period. At the end of two years, 78% were eligible for ≥16-week
dosing, with 53% eligible for ≥20-dosing week intervals.
“It is great to see aflibercept 8 mg deliver another set of
exciting results,” said Charles C. Wykoff, M.D., Ph.D., Director of
Research at Retina Consultants of Texas and a trial investigator.
“In the PULSAR trial, aflibercept 8 mg achieved impressive
durability, while importantly maintaining visual acuity gains from
year one through year two. These data are consistent with the
results from the PHOTON trial in diabetic macular edema, with both
trials demonstrating a consistent safety profile with substantially
fewer treatments than EYLEA. If approved by regulatory authorities,
aflibercept 8 mg has the potential to become the new standard of
care for diabetic macular edema and wet age-related macular
degeneration.”
PULSAR (N= 1,009) is a double-masked, active-controlled pivotal
trial evaluating non-inferiority of aflibercept 8 mg 12-week
(n=335) and 16-week (n=338) dosing regimens compared to an 8-week
dosing regimen for EYLEA® (aflibercept) Injection (n=336). All
patients received three initial monthly doses. The PULSAR trial met
its primary endpoint last year with aflibercept 8 mg patients
achieving clinically equivalent vision gains to EYLEA. Through two
years, vision gains were sustained and remained largely consistent
with the results at one year.
|
Through 48 weeks (one year) |
|
Through 96 weeks (two years) |
|
EYLEA8-week regimen |
aflibercept 8
mg12-weekregimen |
aflibercept 8
mg16-weekregimen |
|
EYLEA8-week regimen |
aflibercept 8
mg12-weekregimen |
aflibercept 8
mg16-weekregimen |
Mean number of injections^ |
6.9 |
6.1 |
5.2 |
|
12.8 |
9.7 |
8.2 |
LS mean (SE) change from baseline, letters |
7.0(0.74) |
6.1(0.77) |
5.9(0.72) |
|
6.6(0.73) |
5.6(0.77) |
5.5(0.75) |
Difference in LS mean (95% CI), letters |
|
-0.97*(-2.87, 0.92) |
-1.14†(-2.97, 0.69) |
|
|
-1.01‡(-2.82, 0.80) |
-1.08§(-2.87, 0.71) |
LS: least squares; SE: standard error ^Based on patients
completing week 48 or 96 in the trial *Non-inferiority p-value:
p=0.0009†Non-inferiority p-value: p=0.0011‡Nominal non-inferiority
p-value: p=0.0006§Nominal non-inferiority p-value:
p=0.0007 In PULSAR,
the safety of aflibercept 8 mg 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 retinal vasculitis, occlusive retinitis or
endophthalmitis in the aflibercept 8 mg group. 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.
“Through one and two years of treatment, aflibercept 8 mg has
repeatedly demonstrated unprecedented durability in maintaining
clinically meaningful outcomes with extended dosing regimens for
patients with retinal disease,” said George D. Yancopoulos,
M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer
at Regeneron, and a principal inventor of EYLEA. “Throughout
the development of aflibercept 8 mg, we have focused on
meaningfully transforming the treatment of retinal disease for
patients. With PHOTON and now PULSAR, we are proud to have produced
landmark, long-term results that may help to reduce the treatment
burden for the millions of people living with wet age-related
macular degeneration and diabetic macular edema around the
world.”
The two-year data from PULSAR are planned for presentation at an
upcoming medical meeting. The two-year data from the pivotal PHOTON
trial for aflibercept 8 mg in DME were presented at
the American Society of Retina Specialists annual meeting
in July 2023.
Aflibercept 8 mg is investigational, and its safety and efficacy
have not been fully evaluated by any regulatory authority.
Aflibercept 8 mg is being jointly developed by Regeneron and Bayer
AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and
aflibercept 8 mg. Bayer has licensed the exclusive marketing rights
outside of the U.S., where the companies share equally the profits
from sales of EYLEA and aflibercept 8 mg following any regulatory
approvals.
About the Aflibercept 8 mg 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:
aflibercept 8 mg every 12 weeks, aflibercept 8 mg 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 aflibercept 8 mg 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 aflibercept 8 mg 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 DMEwAMD 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.
DME is a common complication in eyes of people living with
diabetes. DME occurs when high levels of blood sugar lead to
damaged blood vessels in the eye that leak fluid into the macula.
This can lead to vision loss and, in some cases, blindness. Of the
nearly 28 million American adults living with diabetes, an
estimated 1.2 million have 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
aflibercept 8 mg, 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 EYLEA SAFETY INFORMATION AND
INDICATIONS
INDICATIONSEYLEA (aflibercept) Injection 2 mg
(0.05 mL) 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), Diabetic Retinopathy (DR) and Retinopathy of
Prematurity (ROP) (0.4 mg [0.01 mL]).
CONTRAINDICATIONS
- EYLEA 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.
WARNINGS AND PRECAUTIONS
- 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 and/or caregivers should be instructed to report
any signs and/or 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.
- In infants with ROP, reactivation of abnormal angiogenesis and
tortuosity may occur following treatment with EYLEA. Infants should
be monitored closely after injection with EYLEA until retinal
vascularization has completed or until the examiner is assured that
reactivation of ROP will not occur. Treatment with EYLEA will
necessitate extended periods of ROP monitoring and additional EYLEA
injections and/or laser treatments may be necessary.
- 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.
ADVERSE REACTIONS
- 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.
- In pre-term infants with ROP receiving EYLEA the most common
adverse reactions (≥4%) reported were retinal detachment,
conjunctival hemorrhage, and intraocular pressure increased.
Adverse reactions established for adult indications are considered
applicable to pre-term infants with ROP, though not all were
observed in the clinical studies.
- Patients may experience temporary visual disturbances after an
intravitreal injection with EYLEA and the associated eye
examinations. Advise patients not to drive or use machinery until
visual function has recovered sufficiently.
For more information, please see full Prescribing
Information.
About RegeneronRegeneron 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, Regeneron's
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 Regeneron's 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 its
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 additional information about Regeneron, please
visit www.regeneron.com or follow Regeneron
on LinkedIn.
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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,”
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concern, and these risks and uncertainties include, among others,
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applications of products marketed or otherwise commercialized by
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“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
aflibercept 8 mg; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron’s Product
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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 (such as aflibercept 8 mg) in patients, including
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competing drugs and product candidates that may be superior to, or
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research and development programs conducted by Regeneron and/or its
collaborators or licensees may be replicated in other studies
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unanticipated expenses; the costs of developing, producing, and
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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 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
information, future events, or otherwise.
Regeneron uses its media and investor relations website and
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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
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(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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