Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that
SYFOVRE® (pegcetacoplan injection) preserved visual function at 36
months in patients with geographic atrophy (GA) secondary to
age-related macular degeneration (AMD). These positive data from
the GALE long-term extension study were presented at the Clinical
Trials at the Summit (CTS) Meeting on June 8 in Park City, Utah.
“SYFOVRE is the only approved GA treatment to show a benefit on
visual function in a prespecified endpoint,” said Dilsher Dhoot,
M.D., presenting author, vitreoretinal surgeon, California Retina
Consultants, Santa Barbara, CA. “The vision loss caused by GA is
devastating for patients, taking away their ability to drive and
read. These groundbreaking data clearly demonstrate SYFOVRE’s
potential to make a meaningful difference for patients.”
In a prespecified microperimetry endpoint, patients developed
fewer new scotomatous points with 36 months of both continuous
monthly (p=0.0156) and every-other-month (p=0.1233) treatment
compared to patients from the sham crossover group (all p-values
nominal). Scotomatous points measure areas of the retina that have
lost all light sensitivity and therefore are no longer
functioning.
“These results further reinforce the importance of slowing GA
lesion growth to preserve visual function, adding to the largest
body of evidence for a GA treatment,” said Caroline Baumal, M.D.,
chief medical officer, Apellis. “As leaders in GA, we are committed
to advancing our understanding of the benefits of SYFOVRE on this
progressive and long-term disease.”
View full table by clicking on this link or the image below:
About the GALE Long-Term Extension StudyGALE
(n=792) is a Phase 3, multicenter, open-label, extension study to
evaluate the long-term efficacy and safety of
SYFOVRE® (pegcetacoplan injection) in patients with geographic
atrophy (GA) secondary to age-related macular degeneration (AMD).
The objectives of the study are to evaluate the long-term incidence
and severity of ocular and systemic treatment emergent adverse
events as well as change in the total area of GA lesions as
measured by fundus autofluorescence. More than 80-percent of
participants who completed the OAKS and DERBY studies entered the
GALE study. GALE also includes 10 patients who were previously
enrolled in the Phase 1b study of pegcetacoplan for GA.
Patients in the sham crossover group completed sham treatment
from Months 0-24 in the Phase 3 OAKS study and received SYFOVRE
from Months 24-36. Microperimetry was a key secondary endpoint
measured only in the OAKS study, and therefore, patients who
crossed over from the OAKS study were included in this
analysis.
About the Phase 3 OAKS and DERBY StudiesOAKS
(n=637) and DERBY (n=621) are Phase 3, multicenter, randomized,
double-masked, sham-controlled studies comparing the efficacy and
safety of SYFOVRE® (pegcetacoplan injection) with sham
injections across a broad and heterogenous population of patients
with geographic atrophy (GA) secondary to age-related macular
degeneration (AMD). The studies evaluated the efficacy of monthly
and every-other-month SYFOVRE in patients with GA assessed by
change in the total area of GA lesions from baseline as measured by
fundus autofluorescence.
In Phase 3 studies at 24 months, both every-other-month and
monthly SYFOVRE reduced GA lesion growth with increasing effects
over time and showed a well-demonstrated safety profile.
About
SYFOVRE® (pegcetacoplan
injection)SYFOVRE® (pegcetacoplan injection) is the
first-ever approved therapy for geographic atrophy (GA). By
targeting C3, SYFOVRE is designed to provide comprehensive control
of the complement cascade, part of the body’s immune system.
SYFOVRE is approved in the United States for the treatment of GA
secondary to age-related macular degeneration.
About Geographic Atrophy (GA)Geographic atrophy
(GA) is an advanced form of age-related macular degeneration and a
leading cause of blindness worldwide, impacting more than one
million Americans and five million people worldwide.1,2 It is
a progressive and irreversible disease caused by the growth of
lesions, which destroy the retinal cells responsible for vision.
The vision loss caused by GA severely impairs independence and
quality of life by making it difficult to participate in daily
activities. On average, it takes only 2.5 years for GA lesions to
start impacting the fovea, which is responsible for central
vision.3
U.S. Important Safety Information for
SYFOVRE® (pegcetacoplan
injection) CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or
periocular infections, and in patients with active intraocular
inflammation
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including those with SYFOVRE, may be
associated with endophthalmitis and retinal detachments. Proper
aseptic injection technique must always be used when administering
SYFOVRE to minimize the risk of endophthalmitis. Patients should be
instructed to report any symptoms suggestive of endophthalmitis or
retinal detachment without delay and should be managed
appropriately.
- Retinal Vasculitis and/or Retinal Vascular Occlusion
- Retinal vasculitis and/or retinal vascular occlusion, typically
in the presence of intraocular inflammation, have been reported
with the use of SYFOVRE. Cases may occur with the first dose of
SYFOVRE and may result in severe vision loss. Discontinue treatment
with SYFOVRE in patients who develop these events. Patients should
be instructed to report any change in vision without delay.
- Neovascular AMD
- In clinical trials, use of SYFOVRE was associated with
increased rates of neovascular (wet) AMD or choroidal
neovascularization (12% when administered monthly, 7% when
administered every other month and 3% in the control group) by
Month 24. Patients receiving SYFOVRE should be monitored for signs
of neovascular AMD. In case anti-Vascular Endothelial Growth Factor
(anti-VEGF) is required, it should be given separately from SYFOVRE
administration.
- Intraocular Inflammation
- In clinical trials, use of SYFOVRE was associated with episodes
of intraocular inflammation including: vitritis, vitreal cells,
iridocyclitis, uveitis, anterior chamber cells, iritis, and
anterior chamber flare. After inflammation resolves, patients may
resume treatment with SYFOVRE.
- Increased Intraocular Pressure
- Acute increase in IOP may occur within minutes of any
intravitreal injection, including with SYFOVRE. Perfusion of the
optic nerve head should be monitored following the injection and
managed as needed.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) are ocular
discomfort, neovascular age-related macular degeneration, vitreous
floaters, conjunctival hemorrhage.
Please see accompanying full Prescribing Information for more
information.
About Apellis Apellis
Pharmaceuticals, Inc. is a global biopharmaceutical company that
combines courageous science and compassion to develop life-changing
therapies for some of the most challenging diseases patients face.
We ushered in the first new class of complement medicine in 15
years and now have two approved medicines targeting C3. These
include the first-ever therapy for geographic atrophy, a leading
cause of blindness around the world. We believe we have only begun
to unlock the potential of targeting C3 across serious retinal,
rare, and neurological diseases. For more information, please visit
http://apellis.com or follow us
on Twitter and LinkedIn.
Apellis Forward-Looking StatementStatements in
this press release about future expectations, plans and prospects,
as well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements”
within the meaning of The Private Securities Litigation Reform Act
of 1995. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors and other factors discussed in the “Risk
Factors” section of Apellis’ Annual Report on Form 10-K with the
Securities and Exchange Commission on February 27, 2024 and the
risks described in other filings that Apellis may make with the
Securities and Exchange Commission. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Apellis specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.Media Contact: Lissa
Pavluk media@apellis.com 617.977.6764
Investor Contact: Meredith
Kaya meredith.kaya@apellis.com617.599.8178
1Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender
variations in age-related macular degeneration prevalence in
populations of European ancestry: a meta analysis. Ophthalmology
2012;119:571–580.2Wong WL, Su X, Li X, et al. Global prevalence of
age-related macular degeneration and disease burden projection for
2020 and 2040: a systematic review and meta-analysis. Lancet Glob
Health 2014;2:e106–116.3Lindblad AS, et al, and AREDS Research
Group. Arch Ophthalmol. 2009;127(9):1168-1174.
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