PHOTON and PULSAR data presentations demonstrate aflibercept
8 mg led to sustained improvements in vision and anatomic
measures of retinal fluid across the 48-week treatment period in
both 12- and 16-week dosing regimens
TARRYTOWN, N.Y., Sept. 30,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced the first presentations of positive
detailed results from two pivotal trials investigating novel
aflibercept 8 mg with 12- and 16-week dosing regimens, compared to
EYLEA® (aflibercept) Injection, in patients with
diabetic macular edema (DME) and wet age-related macular
degeneration (wAMD). The data were presented in a late-breaking
session at the American Academy of Ophthalmology (AAO) annual
meeting in Chicago and will
support the submission of a new Biologics License Application to
the U.S. Food and Drug Administration by early 2023.
"Our presentations at AAO demonstrate that aflibercept 8 mg 12-
and 16-week dosing regimens have achieved a high bar, sustaining
improvements in visual acuity and anatomic measures of retinal
fluid across 48 weeks in patients with diabetic macular edema and
wet age-related macular degeneration," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at
Regeneron, and a principal inventor of aflibercept. "These results
were all achieved in patients who were rapidly initiated on
extended dosing intervals with the vast majority not requiring
regimen modification. Altogether, the pivotal data support
aflibercept 8 mg as providing a longer duration of action while
maintaining a safety profile similar to EYLEA."
As presented at AAO, the PHOTON trial in DME and the PULSAR
trial in wAMD both met the same primary endpoint. Aflibercept 8 mg
demonstrated non-inferiority in vision gains in both the 12- and
16-week dosing regimens after initial monthly doses at 48 weeks
compared to an EYLEA 8-week dosing regimen. Furthermore, 91% and
89% of DME patients and 79% and 77% of wAMD patients respectively
randomized to 12- and 16-week dosing maintained those intervals
through 48 weeks. The safety of aflibercept 8 mg was similar to
EYLEA in both trials, and consistent with the known safety profile
of EYLEA from previous clinical trials. Comparing aflibercept 8 mg
to EYLEA, ocular adverse events occurred in 31% versus 28% in
PHOTON and 38% versus 39% in PULSAR, and there were no cases of
retinal vasculitis, occlusive retinitis or endophthalmitis in
either trial.
Data from PHOTON and PULSAR were first shared in early
September, and the full AAO presentations are available on the
Regeneron website.
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.
Aflibercept 8 mg is investigational, and its safety and efficacy
have not been evaluated by any regulatory authority.
About the Aflibercept 8 mg Trial
Program
PHOTON in DME (N=658) and PULSAR in wAMD
(N=1,009) 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.
Patients treated with aflibercept 8 mg in both trials had 3
initial monthly doses, and patients treated with EYLEA received 5
initial monthly doses in PHOTON and 3 in PULSAR. 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,
with those results still to be assessed. Patients in all EYLEA
groups maintained a fixed 8-week dosing regimen throughout their
participation in the trials.
The lead sponsors of the trials were Regeneron for PHOTON and
Bayer for PULSAR.
About DME and 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.
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 1.1 million
Americans have wAMD, and this number is expected to double by
2050.
IMPORTANT EYLEA SAFETY INFORMATION AND INDICATIONS
INDICATIONS
EYLEA® (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), and Diabetic Retinopathy (DR).
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 should be instructed to report any 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.
- 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.
- 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 Regeneron
Regeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for nearly 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
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, pain, 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.
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