Apellis Announces 11 Oral Presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
01 Mayo 2024 - 6:00AM
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that
14 abstracts, 11 of which are oral presentations, will be presented
at the Association for Research in Vision and Ophthalmology (ARVO)
Annual Meeting to be held May 5 - 9 in Seattle. The data continue
to reinforce the robust efficacy and safety profile of SYFOVRE®
(pegcetacoplan injection) for geographic atrophy (GA) secondary to
age-related macular degeneration (AMD).
“The 11 oral presentations at ARVO speak to the continued
excitement surrounding SYFOVRE, which is the most chosen GA
treatment by retina specialists,” said Caroline Baumal, M.D., chief
medical officer, Apellis. “We are excited to share data that
continue to highlight SYFOVRE’s ability to slow disease progression
with increasing effects over time and its potential to preserve
visual function longer.”
Oral presentations:
- Long-term efficacy and safety of
pegcetacoplan over 36 months: results from 12 months of the GALE
open-label extension study – Ashkan Abbey, M.D. – Sunday, May 5 –
1:45‑2:00 PM PDT (encore)
- Pegcetacoplan vs avacincaptad pegol
in geographic atrophy: an anchored matching-adjusted indirect
comparison of three phase 3 trials – Marco Zarbin, M.D., Ph.D. –
Thursday, May 9 – 2:15‑2:30 PM PDT (encore)
- Pegcetacoplan delays time to loss of
central macular sensitivity: a microperimetry analysis of the phase
3 OAKS study – Rishi Singh, M.D., FASRS – Thursday, May 9 –
3:30‑3:45 PM PDT (encore)
- The SD-OCT correlates of fundus
autofluorescence in geographic atrophy: a comprehensive
point-to-point analysis of fundus autofluorescence with SD-OCT
using phase 3 trials DERBY and OAKS – Konstantinos Balaskas, M.D. –
Sunday, May 5 – 2:15‑2:30 PM PDT
- Variability of perilesional FAF
patterns associated with automated OCT-based PR/RPE loss ratios in
GA progression in the phase 3 OAKS/DERBY trials – Julia Mai, M.D. –
Sunday, May 5 – 4:45‑5:00 PM PDT
- Contrast sensitivity function using
a prototype gaze tracking-based virtual reality headset in
age-related macular degeneration (AMD) – Deepayan Kar, Ph.D., MS –
Monday, May 6 – 8:30‑8:45 AM PDT
- A deep-learning approach to
identifying quantitative OCT biomarkers predictive of visual
deficit measured by microperimetry at 24 months in OAKS
trial – Dun Jack Fu, Ph.D., BMBCh – Tuesday, May 7 –
9:30‑9:45 AM PDT
- AI-based qOCT analysis of phase 3
trials OAKS & DERBY data on the effect of pegcetacoplan on
geographic atrophy – Pallavi Bagga, Ph.D. – Tuesday, May 7 –
2:15‑2:30 PM PDT
- Predictive value of the
photoreceptor/RPE loss ratio on OCT in the management of geographic
atrophy (GA) for patient selection and monitoring of therapeutic
efficacy – Ursula Schmidt‑Erfurth, M.D. – Tuesday, May 7 –
2:30‑2:45 PM PDT
- Rate of response to treatment in
eyes with geographic atrophy treated with Pegcetacoplan in a
within-patient comparison using automated AI-based OCT biomarker
quantifications in OAKS, DERBY and GALE – Gregor S. Reiter,
M.D., Ph.D. – Thursday, May 9 – 2:30‑2:45 PM PDT
- IRIS® Registry analysis of anti-VEGF
treatment in patients with coexisting neovascular age-related
macular degeneration and geographic atrophy – Theodore Leng, M.D.,
FACS – Thursday, May 9 – 3:15‑3:30 PM PDT
Poster presentations:
- Prevalence of outer retinal
tubulation (ORT) and association with geographic atrophy (GA)
growth among patients in the OAKS and DERBY trials – Kensington
Hatcher, O.D., FAAO – Monday, May 6 –
3:00‑4:45 PM PDT
- Loss of independence in geographic
atrophy (GA) - results from the MOSAIC study among patients and
caregivers in Europe – Beverly Lui, PharmD – Thursday, May 9 –
8:00‑9:45 AM PDT
- Deep learning-based segmentation of
geographic atrophy in fundus autofluorescence: external validation
in imaging acquired in a clinical trial – Souvick Mukherjee,
Ph.D. – Thursday, May 9 – 8:00‑9:45 AM PDT
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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