Apellis Announces Five Abstracts Accepted for Oral Presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting
Apellis Pharmaceuticals (Nasdaq: APLS) announced that five abstracts highlighting SYFOVRE® (pegcetacoplan injection) data have been accepted for oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting from July 30 - August 2 in Long Beach, California.
The presentations will showcase SYFOVRE's efficacy and safety profile in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The data demonstrates SYFOVRE's ability to slow GA progression with as few as six doses per year. The abstracts cover various aspects including baseline characteristics, early vs. delayed treatment results, clinical utility in bilateral GA, combination therapy with anti-VEGF treatments, and the impact of AREDS supplements on GA progression.
SYFOVRE is notable as the first-ever approved therapy for GA, a condition affecting over one million Americans and five million people worldwide.
Apellis Pharmaceuticals (Nasdaq: APLS) ha annunciato che cinque abstract che mettono in evidenza i dati su SYFOVRE® (iniezione di pegcetacoplan) sono stati accettati per una presentazione orale al Meeting Scientifico Annuale della American Society of Retina Specialists (ASRS), che si terrà dal 30 luglio al 2 agosto a Long Beach, California.
Le presentazioni metteranno in luce l'efficacia e il profilo di sicurezza di SYFOVRE nel trattamento dell'atrofia geografica (GA) secondaria alla degenerazione maculare legata all'età (AMD). I dati dimostrano la capacità di SYFOVRE di rallentare la progressione della GA con appena sei dosi all'anno. Gli abstract coprono vari aspetti, tra cui caratteristiche basali, risultati del trattamento precoce rispetto a quello ritardato, utilità clinica nella GA bilaterale, terapia combinata con trattamenti anti-VEGF e l'impatto degli integratori AREDS sulla progressione della GA.
SYFOVRE è particolarmente rilevante in quanto rappresenta la prima terapia mai approvata per la GA, una condizione che colpisce oltre un milione di americani e cinque milioni di persone nel mondo.
Apellis Pharmaceuticals (Nasdaq: APLS) anunció que cinco resúmenes que destacan los datos de SYFOVRE® (inyección de pegcetacoplan) han sido aceptados para presentación oral en la Reunión Científica Anual de la American Society of Retina Specialists (ASRS), que tendrá lugar del 30 de julio al 2 de agosto en Long Beach, California.
Las presentaciones mostrarán la eficacia y el perfil de seguridad de SYFOVRE en el tratamiento de la atrofia geográfica (GA) secundaria a la degeneración macular relacionada con la edad (AMD). Los datos demuestran la capacidad de SYFOVRE para ralentizar la progresión de la GA con tan solo seis dosis al año. Los resúmenes abarcan diversos aspectos, incluyendo características basales, resultados de tratamiento temprano frente a tardío, utilidad clínica en GA bilateral, terapia combinada con tratamientos anti-VEGF y el impacto de los suplementos AREDS en la progresión de la GA.
SYFOVRE es notable por ser la primera terapia aprobada para la GA, una condición que afecta a más de un millón de estadounidenses y cinco millones de personas en todo el mundo.
Apellis Pharmaceuticals (나스닥: APLS)는 SYFOVRE®(페그세타플라콘 주사) 데이터와 관련된 다섯 편의 초록이 7월 30일부터 8월 2일까지 캘리포니아 롱비치에서 열리는 미국 망막 전문의 학회(ASRS) 연례 과학 회의에서 구두 발표로 채택되었다고 발표했습니다.
이번 발표에서는 연령 관련 황반변성(AMD)으로 인한 지리적 위축(GA) 치료에 있어 SYFOVRE의 효능과 안전성 프로필을 보여줄 예정입니다. 데이터는 SYFOVRE가 연간 단 6회 투여로 GA 진행을 늦출 수 있음을 입증합니다. 초록들은 기저 특성, 조기 대 지연 치료 결과, 양측 GA에서의 임상적 유용성, 항-VEGF 치료와의 병용 요법, AREDS 보충제가 GA 진행에 미치는 영향 등 다양한 측면을 다룹니다.
SYFOVRE는 GA에 대해 최초로 승인된 치료제로, 미국에서만 100만 명 이상, 전 세계적으로 500만 명 이상의 환자에게 영향을 미치는 질환입니다.
Apellis Pharmaceuticals (Nasdaq : APLS) a annoncé que cinq résumés mettant en avant les données de SYFOVRE® (injection de pegcetacoplan) ont été acceptés pour une présentation orale lors de la Réunion Scientifique Annuelle de l'American Society of Retina Specialists (ASRS), qui se tiendra du 30 juillet au 2 août à Long Beach, Californie.
Les présentations mettront en lumière l'efficacité et le profil de sécurité de SYFOVRE dans le traitement de l'atrophie géographique (GA) secondaire à la dégénérescence maculaire liée à l'âge (DMLA). Les données démontrent la capacité de SYFOVRE à ralentir la progression de la GA avec seulement six doses par an. Les résumés couvrent divers aspects, notamment les caractéristiques initiales, les résultats du traitement précoce versus différé, l'utilité clinique dans la GA bilatérale, la thérapie combinée avec des traitements anti-VEGF, et l'impact des compléments AREDS sur la progression de la GA.
SYFOVRE est notable en tant que premier traitement approuvé pour la GA, une maladie qui touche plus d'un million d'Américains et cinq millions de personnes dans le monde.
Apellis Pharmaceuticals (Nasdaq: APLS) gab bekannt, dass fünf Abstracts mit Daten zu SYFOVRE® (Pegcetacoplan-Injektion) für eine mündliche Präsentation auf dem Jahreswissenschaftstreffen der American Society of Retina Specialists (ASRS) vom 30. Juli bis 2. August in Long Beach, Kalifornien, angenommen wurden.
Die Präsentationen werden die Wirksamkeit und das Sicherheitsprofil von SYFOVRE bei der Behandlung der geografischen Atrophie (GA) infolge der altersbedingten Makuladegeneration (AMD) hervorheben. Die Daten zeigen, dass SYFOVRE die Progression der GA mit nur sechs Dosen pro Jahr verlangsamen kann. Die Abstracts behandeln verschiedene Aspekte, darunter Basislinienmerkmale, Ergebnisse von früher versus verzögerter Behandlung, klinischer Nutzen bei bilateraler GA, Kombinationstherapie mit Anti-VEGF-Behandlungen und den Einfluss von AREDS-Ergänzungen auf den GA-Verlauf.
SYFOVRE ist bemerkenswert als die erste jemals zugelassene Therapie für GA, eine Erkrankung, die über eine Million Amerikaner und fünf Millionen Menschen weltweit betrifft.
- First-ever approved therapy for geographic atrophy (GA)
- Treatment requires only six doses per year
- Strong market adoption as 'most chosen treatment for GA'
- Addresses a large market of over 1 million Americans and 5 million people worldwide
- Risk of serious complications including endophthalmitis and retinal detachments
- Increased rates of neovascular AMD reported in clinical trials (12% monthly, 7% bi-monthly vs 3% control)
- Potential adverse effects including intraocular inflammation and increased intraocular pressure
Insights
Apellis strengthens SYFOVRE's market position with five key presentations demonstrating efficacy and safety in geographic atrophy treatment.
The announcement of five oral presentations at the prestigious ASRS meeting represents a significant validation for SYFOVRE's clinical profile in the geographic atrophy (GA) landscape. As "the most chosen treatment for GA," these presentations will likely further solidify physician confidence in the therapy. The data specifically highlighting SYFOVRE's efficacy with "as few as six doses per year" addresses a critical factor in treatment adoption for this elderly patient population, where treatment burden remains a key consideration.
The presentations cover crucial aspects that influence real-world treatment decisions: baseline characteristics affecting progression, early versus delayed treatment outcomes at 48 months, fellow eye data for bilateral disease assessment, combination therapy with anti-VEGF agents, and interactions with AREDS supplements. These represent precisely the types of practical clinical questions retina specialists face when implementing SYFOVRE in practice.
Geographic atrophy affects over one million Americans and five million people worldwide, with rapid progression - lesions typically impact central vision (fovea) within just 2.5 years. Before SYFOVRE's approval, there were no treatments available for this form of macular degeneration. The continued data generation demonstrates Apellis' commitment to expanding the evidence base beyond the pivotal trials that led to approval.
The safety data being presented is particularly important given the post-approval concerns about retinal vasculitis. These presentations will likely help retina specialists better understand the benefit-risk profile, potentially expanding adoption among physicians who may have taken a wait-and-see approach following initial safety signals.
WALTHAM, Mass., July 15, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that five abstracts were accepted for oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 30 - August 2 in Long Beach, California. These data further demonstrate 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).
“Retina specialists continue to be excited about SYFOVRE – the most chosen treatment for GA – as demonstrated by the five oral presentations at this prestigious meeting,” said Caroline Baumal, M.D., chief medical officer, Apellis. “As leaders in GA, we are proud to present data that highlights SYFOVRE’s unique ability to slow GA progression in as few as six doses per year, offering hope to patients living with this progressive and irreversible disease.”
Presentations include:
- Baseline Characteristics Associated with Geographic Atrophy Progression in the OAKS and DERBY Trials - Srinivas R. Sadda, MD - Dry AMD Symposium 1 - Thursday, July 31, 2:16- 2:19 p.m. PT
- Early vs Delayed Pegcetacoplan Treatment for GA Secondary to AMD: 48-Month Results from OAKS, DERBY, and GALE Open-Label Extension - Roger A. Goldberg, MD, MBA - Dry AMD Symposium 1 - Thursday, July 31, 2:19 - 2:22 p.m. PT
- Clinical Utility of the Fellow Eye in Patients with Bilateral GA due to AMD: Long-Term Data from the Pegcetacoplan Clinical Program - Diana V. Do, MD, FASRS - Dry AMD Symposium 1 - Thursday, July 31, 2:22 - 2:25 p.m. PT
- A Descriptive Analysis of Patients Who Received Pegcetacoplan and Anti-VEGF for the Treatment of Geographic Atrophy and Neovascular AMD - Nimesh A. Patel, MD, FASRS - Dry AMD Symposium 1 - Thursday, July 31, 2:38- 2:41 p.m. PT
- Impact of AREDS Oral Micronutrient Supplementation on Geographic Atrophy Progression: Insights from the Phase 3 OAKS and DERBY Trials - Paul Hahn, MD, PhD, FASRS - Dry AMD Symposium 2 - Thursday, July 31, 3:14 - 3:17 p.m. PT
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, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred.
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 and3% 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.
- In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (
- 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.
- 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 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. 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 X 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 28, 2025 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.
Contacts:
Media
Tracy Vineis
media@apellis.com
617.420.4839
Investors
Neil Carnahan, CFA
neil.carnahan@apellis.com
References
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.
