- Late-breaking presentation shows SYFOVRE® (pegcetacoplan injection) demonstrated visual function benefit on prespecified endpoint in GALE long-term extension study
WALTHAM, Mass., July 09, 2024 (GLOBE NEWSWIRE) — 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 Study
GALE (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 Studies
OAKS (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 Vineis
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617.420.4839
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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.
