Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the
first presentation of positive two-year (96 weeks) results from the
pivotal PHOTON trial investigating aflibercept 8 mg with 12- and
16-week dosing regimens, compared to EYLEA® (aflibercept)
Injection, in patients with diabetic macular edema (DME). The
results were presented at the American Society of Retina
Specialists (ASRS) annual meeting.
“At two years, the PHOTON trial demonstrates the substantial
impact aflibercept 8 mg could have in reducing treatment burden for
patients with diabetic macular edema,” said Diana V. Do, MD,
Professor of Ophthalmology and Vice Chair for Clinical Affairs at
the Byers Eye Institute, Stanford University and a trial
investigator. “Maintaining two years of vision and anatomic
improvements with as few as three or four injections per year,
while not compromising safety, is impressive and could make a
meaningful difference in the lives of the patients we treat.”
PHOTON (N=658) is a double-masked, active-controlled pivotal
trial evaluating non-inferiority of aflibercept 8 mg extended
dosing intervals compared to EYLEA. Patients receiving aflibercept
8 mg were initially randomized to either 12- (n=328) or 16-week
(n=163) dosing intervals (after three initial monthly doses)
compared to an 8-week dosing regimen for EYLEA (n=167) after five
initial monthly doses. During the trial, patients receiving
aflibercept 8 mg could have their dosing intervals shortened down
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 PHOTON trial met its primary endpoint last year with
aflibercept 8 mg patients achieving clinically equivalent vision
gains to EYLEA, with approximately 90% maintaining 12- and 16-week
dosing regimens through the first year. Through two years, the mean
number of injections administered were 9.5 for the 12-week
aflibercept 8 mg group, 7.8 for the 16-week aflibercept 8 mg group,
and 13.8 for the EYLEA group, with the vast majority of aflibercept
8 mg patients maintaining extended dosing intervals as first shared
in June 2023:
- 89% of patients maintained ≥12-week dosing intervals, compared
to 93% through one year
- 84% maintained ≥16-week dosing intervals, compared to 89%
maintaining a 16-week dosing interval through one year, among those
randomized at baseline to a 16-week dosing interval
- 44% met the criteria for ≥20-week dosing intervals at week 96,
including 17% and 27% who were eligible for 20- and 24-week dosing
intervals, respectively
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 DME. Ocular
treatment emergent adverse events (TEAE) occurring in 5% of
patients in any treatment group, in decreasing frequency, were
cataract, vitreous floaters and conjunctival hemorrhage. There were
no cases of retinal vasculitis, occlusive retinitis or
endophthalmitis. The rate of intraocular inflammation was 1.2% for
both the EYLEA and aflibercept 8 mg groups. Anti-platelet
trialists' collaboration-defined arterial thromboembolic TEAEs
occurred in 7.2% of patients treated with EYLEA and 6.7% of
patients treated with aflibercept 8 mg.
The full ASRS presentation is available on the Regeneron
website. The two-year data from the pivotal PULSAR trial for
aflibercept 8 mg in wet age-related macular degeneration (wAMD) are
expected in the third quarter of 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, with Regeneron sponsoring the PHOTON trial. 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. During the trial, 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 DMEDME 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 is being 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 (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 9 FDA-approved treatments and numerous
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 Twitter.
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 aflibercept 8 mg; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron’s Product Candidates (including aflibercept 8 mg) and new
indications for Regeneron’s Products; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron’s Products and Regeneron’s Product Candidates (such as
aflibercept 8 mg) 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 or any potential regulatory approval of
Regeneron’s Products and Regeneron’s Product Candidates; 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 (such as aflibercept 8 mg) 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 (including, if approved, aflibercept 8 mg)
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, Praluent® (alirocumab), 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
March 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 (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
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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