Apellis Announces Five Abstracts Accepted for Oral Presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting
July 09 2024 - 7:00AM
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that
six abstracts, five of which are oral presentations, will be
presented at the American Society of Retina Specialists (ASRS)
Annual Scientific Meeting to be held July 17 - 20 in Stockholm,
Sweden. These data reinforce the robust efficacy and
well-documented safety profile of SYFOVRE® (pegcetacoplan
injection) for patients with geographic atrophy (GA) secondary to
age-related macular degeneration (AMD).
“We look forward to sharing data that further demonstrate why
SYFOVRE is the most chosen GA treatment by retina specialists,
highlighting its ability to slow disease progression with
increasing effects over time,” said Caroline Baumal, M.D., chief
medical officer, Apellis. “We are thrilled to present results
showing that SYFOVRE demonstrated a visual function benefit in a
prespecified microperimetry endpoint at 36 months in GALE.”
Presentations include:
- Pegcetacoplan vs Avacincaptad Pegol in Geographic Atrophy:
Anchored Matching-Adjusted Indirect Comparisons of Three Phase 3
Trials Over 24 Months – Paul Hahn, MD, PhD, FASRS - Dry AMD
Symposium 1 - Wednesday, July 17, 9:31-9:35 a.m. CEST
- Identification of
Disease Activity and Therapeutic Response in Geographic Atrophy by
Human Experts and OCT-Based AI Analysis in Pegcetacoplan Therapy –
Ursula M Schmidt-Erfurth, MD - Expert Panel: Artificial
Intelligence - Wednesday, July 17, 11:00-11:20 a.m. CEST
- Predictive Role of
Outer Retinal Tubulation in Lesion Growth for Subfoveal and
Nonsubfoveal Geographic Atrophy - Srinivas Sai A Kondapalli, MD -
Imaging Symposium 1 – Thursday, July 18, 8:34-8:38 a.m. CEST
- Update on
Pegcetacoplan for Geographic Atrophy: Clinical Studies and
Real-World Experience - David A Eichenbaum, MD, FASRS - Expert
Panel: Pegcetacoplan – Thursday, July 18, 3:25-3:45 p.m. CEST
- Visual Function
Benefit of Pegcetacoplan on a Prespecified Microperimetry Endpoint
after 36 Months of Continuous Treatment from GALE - Sunir J Garg,
MD, FACS, FASRS - Expert Panel: Pegcetacoplan - 3:25-3:45 p.m.
CEST
- Beneficial Effects
in Macular Function With Continuous Pegcetacoplan Treatment: OAKS,
DERBY, and GALE Open-Label Extension - Mathew W MacCumber, MD, PhD,
FASRS - POD 1: AMD
About GALE Long-Term Extension StudyGALE
(n=792) is a Phase 3, multicenter, open label, extension study to
evaluate the long-term safety and efficacy 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 and only
therapy for geographic atrophy, a leading cause of blindness around
the world. With nearly a dozen clinical and pre-clinical programs
underway, we believe we have only begun to unlock the potential of
targeting C3 across many serious diseases. For more information,
please visit http://apellis.com or follow us
on Twitter and LinkedIn.
Apellis Forward-Looking
Statement Statements 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, including whether the data analyses reported in this
release indicate an apparent positive effect that is greater than
the actual positive effect, 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:Tracy
Vineismedia@apellis.com617.420.4839
Investor Contact:Meredith
Kayameredith.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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