Apellis Receives Approval of SYFOVRE® (pegcetacoplan) in Australia for Geographic Atrophy (GA)
Apellis Pharmaceuticals (APLS) has received approval from Australia's Therapeutic Goods Administration (TGA) for SYFOVRE® (pegcetacoplan) to treat geographic atrophy (GA) in adults. SYFOVRE becomes the first and only approved treatment for GA in Australia, where over 75,000 people are affected by this condition.
The treatment is specifically approved for adult patients with GA secondary to age-related macular degeneration (AMD) with an intact fovea, particularly when central vision is threatened by GA lesion growth. The approval is based on Phase 3 OAKS and DERBY studies results at 24 months, which demonstrated that both monthly and every-other-month SYFOVRE treatments effectively slowed GA progression with a generally well-tolerated safety profile.
GA is a progressive and irreversible disease that leads to blindness by destroying retinal cells responsible for vision. The condition significantly impacts patients' independence and quality of life, affecting their ability to read, drive, and recognize faces.
Apellis Pharmaceuticals (APLS) ha ricevuto l'approvazione dall'Australian Therapeutic Goods Administration (TGA) per SYFOVRE® (pegcetacoplan) per il trattamento dell'atrofia geografica (GA) negli adulti. SYFOVRE diventa il primo e unico trattamento approvato per la GA in Australia, dove oltre 75.000 persone sono affette da questa condizione.
Il trattamento è specificamente approvato per pazienti adulti con GA secondaria alla degenerazione maculare legata all'età (AMD) con fovea intatta, in particolare quando la visione centrale è minacciata dalla crescita delle lesioni GA. L'approvazione si basa sui risultati degli studi di fase 3 OAKS e DERBY a 24 mesi, che hanno dimostrato che sia i trattamenti mensili sia quelli ogni due mesi di SYFOVRE hanno rallentato efficacemente la progressione della GA con un profilo di sicurezza generalmente ben tollerato.
La GA è una malattia progressiva e irreversibile che porta alla cecità distruggendo le cellule retiniche responsabili della visione. La condizione impatta significativamente sull'indipendenza e sulla qualità della vita dei pazienti, influenzando la loro capacità di leggere, guidare e riconoscere volti.
Apellis Pharmaceuticals (APLS) ha recibido la aprobación de la Therapeutic Goods Administration (TGA) de Australia para SYFOVRE® (pegcetacoplan) para tratar la atrofia geográfica (GA) en adultos. SYFOVRE se convierte en el primer y único tratamiento aprobado para la GA en Australia, donde más de 75,000 personas están afectadas por esta condición.
El tratamiento está específicamente aprobado para pacientes adultos con GA secundaria a la degeneración macular relacionada con la edad (AMD) con fovea intacta, particularmente cuando la visión central está amenazada por el crecimiento de lesiones de GA. La aprobación se basa en los resultados de los estudios de fase 3 OAKS y DERBY a 24 meses, que demostraron que tanto los tratamientos mensuales como los bimensuales de SYFOVRE ralentizaban efectivamente la progresión de la GA con un perfil de seguridad generalmente bien tolerado.
La GA es una enfermedad progresiva e irreversible que conduce a la ceguera al destruir las células retinianas responsables de la visión. La condición afecta significativamente la independencia y la calidad de vida de los pacientes, afectando su capacidad para leer, conducir y reconocer rostros.
Apellis Pharmaceuticals (APLS)는 호주 치료재화처(TGA)로부터 성인에서 지리적 위축(GA)을 치료하기 위해 SYFOVRE® (pegcetacoplan)의 승인을 받았습니다. SYFOVRE는 호주에서 GA에 대해 승인된 최초이자 유일한 치료법이 되며, 이 질환에 75,000명 이상의 사람들이 영향을 받고 있습니다.
이 치료법은 특히 중앙 시력이 GA 병변의 성장으로 위협받는 경우에, 황반 기능이 정상인 성인 환자에 대해 GA의 2차적인 치료로 승인되었습니다. 이 승인은 24개월 동안의 3상 OAKS 및 DERBY 연구 결과를 바탕으로 하며, 매월 또는 격월 SYFOVRE 치료가 GA 진행 속도를 효과적으로 늦추고 일반적으로 잘 내약되는 안전성 프로필을 보였음을 입증합니다.
GA는 시력을 담당하는 망막 세포를 파괴하여 실명으로 이어지는 진행성이고 되돌릴 수 없는 질환입니다. 이 질환은 환자의 독립성과 삶의 질에 중대한 영향을 미치며, 읽기, 운전 및 얼굴 인식 능력에 영향을 줍니다.
Apellis Pharmaceuticals (APLS) a reçu l'approbation de l'Administration des biens thérapeutiques d'Australie (TGA) pour SYFOVRE® (pegcetacoplan) afin de traiter l'atrophie géographique (GA) chez les adultes. SYFOVRE devient le premier et le seul traitement approuvé pour la GA en Australie, où plus de 75 000 personnes sont touchées par cette condition.
Le traitement est spécifiquement approuvé pour les patients adultes atteints de GA secondaire à la dégénérescence maculaire liée à l'âge (AMD) avec une fovéa intacte, en particulier lorsque la vision centrale est menacée par la croissance des lésions GA. L'approbation est basée sur les résultats des études de phase 3 OAKS et DERBY à 24 mois, qui ont démontré que les traitements SYFOVRE à la fois mensuels et bimensuels ralentissaient efficacement la progression de la GA avec un profil de sécurité généralement bien toléré.
La GA est une maladie progressive et irréversible qui entraîne la cécité en détruisant les cellules rétiniennes responsables de la vision. Cette condition a un impact significatif sur l'indépendance et la qualité de vie des patients, affectant leur capacité à lire, conduire et reconnaître des visages.
Apellis Pharmaceuticals (APLS) hat die Genehmigung der Therapeutic Goods Administration (TGA) Australiens für SYFOVRE® (pegcetacoplan) zur Behandlung der geografischen Atrophie (GA) bei Erwachsenen erhalten. SYFOVRE wird die erste und einzige genehmigte Behandlung für GA in Australien, wo über 75.000 Menschen von dieser Erkrankung betroffen sind.
Die Behandlung ist speziell für erwachsene Patienten mit GA, die sekundär zur altersbedingten Makuladegeneration (AMD) mit intakter Fovea aufgetreten ist, genehmigt, insbesondere wenn das zentrale Sehvermögen durch das Wachstum von GA-Läsionen bedroht ist. Die Genehmigung basiert auf den Ergebnissen der Phase-3-Studien OAKS und DERBY nach 24 Monaten, die zeigen, dass sowohl monatliche als auch alle zwei Monate verabreichte SYFOVRE-Behandlungen die GA-Progression effektiv verlangsamten und ein im Allgemeinen gut verträgliches Sicherheitsprofil aufwiesen.
GA ist eine fortschreitende und irreversible Erkrankung, die zur Erblindung führt, indem sie die für das Sehen verantwortlichen Netzhautzellen zerstört. Die Erkrankung hat erhebliche Auswirkungen auf die Unabhängigkeit und die Lebensqualität der Patienten und betrifft ihre Fähigkeit, zu lesen, zu fahren und Gesichter zu erkennen.
- First and only approved treatment for GA in Australia
- Addresses a large market of 75,000+ Australian patients
- Phase 3 trials showed positive efficacy in slowing disease progression
- Expands global market presence beyond U.S.
- None.
Insights
The Australian approval of SYFOVRE represents a significant commercial opportunity for Apellis in a market with over 75,000 GA patients and no existing treatment options. This regulatory success builds on SYFOVRE's established presence in the U.S. market and signals strong momentum in Apellis's global expansion strategy.
The approval's timing and market dynamics are particularly favorable:
- Australia represents a sophisticated healthcare market with well-established reimbursement pathways through the Pharmaceutical Benefits Scheme (PBS)
- First-mover advantage in the Australian GA market could establish SYFOVRE as the standard of care
- The every-other-month dosing regimen offers a competitive advantage in terms of treatment burden and compliance
- Potential for strong adoption given the validation from U.S. market experience and published Phase 3 data in The Lancet
From a commercial perspective, this approval could contribute meaningfully to Apellis's revenue growth. While the Australian market is smaller than the U.S., the lack of competition and high unmet need suggest potential for rapid market penetration. The next key catalyst will be securing PBS listing, which would significantly enhance accessibility and drive adoption.
WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the first and only approved treatment for GA in Australia.
"The approval of SYFOVRE marks a significant milestone for GA patients across Australia. For the first time, Australians with GA will have a treatment to slow the progression of this irreversible form of vision loss,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “Building on the success in the U.S., we are excited to bring SYFOVRE to even more patients who are impacted by this devastating disease.”
More than 75,000 Australians are living with GA, an advanced form of AMD and leading cause of blindness worldwide.1 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.
“As a retina specialist, I have seen how GA often takes away a person’s ability to read, drive, and even see faces of their loved ones,” said Professor Robyn Guymer, AM, deputy director, Centre for Eye Research Australia. “The approval of SYFOVRE is a historic moment full of hope for the Australian GA community, who have been waiting for a treatment.”
The approval is based on results from the Phase 3 OAKS and DERBY studies at 24 months. In the studies, treatment with both every-other-month and monthly SYFOVRE slowed GA progression and showed a generally well-tolerated safety profile. The results were published in The Lancet in October 2023.
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 and Australia.
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 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 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 Quarterly Report on Form 10-Q filed on November 5, 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.com
617.599.8178
References
- Keel S, Xie J, Foreman J, van Wijngaarden P, Taylor HR, Dirani M. Prevalence of Age-Related Macular Degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. Nov 1 2017;135(11):1242-1249. doi:10.1001/jamaophthalmol.2017.4182
FAQ
What is the significance of SYFOVRE's approval in Australia for Apellis (APLS)?
What clinical trial results supported SYFOVRE's Australian approval for APLS?
How many Australian patients could potentially benefit from APLS's SYFOVRE treatment?
What specific condition does APLS's SYFOVRE treat in the Australian market?
