U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy
Astellas Pharma announced FDA approval for expanded labeling of IZERVAY™ (avacincaptad pegol intravitreal solution) for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD), now without dosing duration limitations. The approval follows the company's December 2024 supplemental New Drug Application resubmission.
The expansion is supported by positive GATHER2 Phase 3 trial results through year 2, showing IZERVAY reduced GA lesion growth versus sham treatment, with benefits observed as early as 6 months and doubling over 2 years compared to year 1. Since its April 2024 J-code implementation, over 210,000 vials have been distributed in the U.S. through December 2024.
The treatment demonstrated good tolerability over 2 years, with minimal adverse events and consistent post-marketing safety reporting. The financial impact on Astellas' fiscal year ending March 31, 2025, is expected to be minor.
Astellas Pharma ha annunciato l'approvazione da parte della FDA per l'ampliamento dell'etichettatura di IZERVAY™ (soluzione intravitreale di avacincaptad pegol) per il trattamento dell'atrofia geografica (GA) secondaria alla degenerazione maculare legata all'età (AMD), ora senza limitazioni sulla durata della somministrazione. L'approvazione segue la riesamina della domanda supplementare per un nuovo farmaco presentata dall'azienda a dicembre 2024.
Questo ampliamento è supportato dai risultati positivi dello studio clinico GATHER2 Phase 3 fino al secondo anno, che mostrano come IZERVAY riduca la crescita delle lesioni di GA rispetto al trattamento simulato, con benefici osservati già dopo 6 mesi e raddoppiati dopo 2 anni rispetto al primo anno. Dalla sua implementazione del codice J nell'aprile 2024, oltre 210.000 fiale sono state distribuite negli Stati Uniti fino a dicembre 2024.
Il trattamento ha dimostrato una buona tollerabilità per 2 anni, con eventi avversi minimi e un'adeguata segnalazione di sicurezza post-marketing. L'impatto finanziario sull'anno fiscale di Astellas che termina il 31 marzo 2025 è previsto essere di lieve entità.
Astellas Pharma anunció la aprobación de la FDA para la ampliación de la etiqueta de IZERVAY™ (solución intravítrea de avacincaptad pegol) para el tratamiento de la atrofia geográfica (GA) secundaria a la degeneración macular relacionada con la edad (AMD), ahora sin limitaciones en la duración de la dosificación. La aprobación sigue a la reenvío de la solicitud suplementaria de nuevo medicamento de la compañía en diciembre de 2024.
La expansión está respaldada por los resultados positivos del ensayo GATHER2 Phase 3 hasta el año 2, que muestran que IZERVAY redujo el crecimiento de las lesiones de GA en comparación con el tratamiento simulado, con beneficios observados ya a los 6 meses y duplicándose en 2 años en comparación con el primer año. Desde la implementación del código J en abril de 2024, se han distribuido más de 210,000 frascos en los EE. UU. hasta diciembre de 2024.
El tratamiento demostró una buena tolerabilidad durante 2 años, con eventos adversos mínimos y un informe de seguridad post-comercialización consistente. Se espera que el impacto financiero en el año fiscal de Astellas que finaliza el 31 de marzo de 2025 sea menor.
아스텔라스 제약은 IZERVAY™ (아바신캡타드 페골의 유리체 내 주사제)의 라벨 확장을 위해 FDA 승인을 발표했습니다. 이는 노인성 황반변성(AMD)으로 인한 지리적 위축(GA) 치료에 사용되며, 이제 투여 기간 제한이 없습니다. 이 승인은 회사가 2024년 12월에 제출한 보완 신약 신청서의 재제출에 따른 것입니다.
이번 확장은 GATHER2 3상 임상시험 결과의 긍정적인 지원을 받으며, 2년 차까지 IZERVAY가 가짜 치료에 비해 GA 병변 성장 감소를 보여주었고, 6개월 만에 효과가 나타나며 2년 동안 1년 차에 비해 두 배 증가했습니다. 2024년 4월 J코드 시행 이후, 2024년 12월까지 미국에서 210,000개 이상의 바이알이 배포되었습니다.
치료는 2년 동안 좋은 내약성을 보여주었으며, 부작용이 최소화되고 일관된 시판 후 안전성 보고가 이루어졌습니다. 2025년 3월 31일 종료되는 아스텔라스의 회계 연도에 대한 재정적 영향은 미미할 것으로 예상됩니다.
Astellas Pharma a annoncé l'approbation par la FDA de l'extension de l'étiquetage de IZERVAY™ (solution intravitréenne d'avacincaptad pegol) pour le traitement de l'atrophie géographique (GA) secondaire à la dégénérescence maculaire liée à l'âge (AMD), désormais sans limitations de durée de dosage. L'approbation fait suite à la resoumission de la demande de médicament nouveau complémentaire de l'entreprise en décembre 2024.
L'expansion est soutenue par des résultats positifs de l'essai GATHER2 Phase 3 jusqu'à la deuxième année, montrant qu'IZERVAY a réduit la croissance des lésions GA par rapport au traitement simulé, avec des bénéfices observés dès 6 mois et doublant sur 2 ans par rapport à la première année. Depuis la mise en œuvre du code J en avril 2024, plus de 210 000 flacons ont été distribués aux États-Unis jusqu'en décembre 2024.
Le traitement a démontré une bonne tolérance sur 2 ans, avec des événements indésirables minimes et un rapport de sécurité post-commercialisation cohérent. L'impact financier sur l'année fiscale d'Astellas se terminant le 31 mars 2025 devrait être mineur.
Astellas Pharma hat die Genehmigung der FDA für die erweiterte Kennzeichnung von IZERVAY™ (Avacincaptad Pegol intravitreal Lösung) zur Behandlung von geographischer Atrophie (GA) infolge von altersbedingter Makuladegeneration (AMD) bekannt gegeben, jetzt ohne Einschränkungen der Dosierungsdauer. Die Genehmigung folgt der erneuten Einreichung des ergänzenden Antrags auf ein neues Medikament des Unternehmens im Dezember 2024.
Die Erweiterung wird durch positive Ergebnisse der GATHER2 Phase 3 Studie bis zum zweiten Jahr unterstützt, die zeigen, dass IZERVAY das Wachstum der GA-Läsionen im Vergleich zur Scheinbehandlung verringerte, wobei die Vorteile bereits nach 6 Monaten beobachtet wurden und sich über 2 Jahre im Vergleich zum ersten Jahr verdoppelten. Seit der Implementierung des J-Codes im April 2024 wurden bis Dezember 2024 über 210.000 Fläschchen in den USA verteilt.
Die Behandlung zeigte über 2 Jahre eine gute Verträglichkeit mit minimalen unerwünschten Ereignissen und konsistenten Sicherheitsberichten nach der Markteinführung. Die finanziellen Auswirkungen auf das Geschäftsjahr von Astellas, das am 31. März 2025 endet, werden voraussichtlich gering sein.
- FDA approval for extended dosing duration removes previous limitations
- Demonstrated continued efficacy in reducing GA lesion growth through 2 years
- Strong market adoption with over 210,000 vials distributed
- Favorable safety profile maintained in post-marketing surveillance
- Treatment benefits doubled over 2 years compared to year 1
- Slightly increased incidence of choroidal neovascularization (11.6% vs 9% in sham)
- Minor expected financial impact for fiscal year ending March 2025
IZERVAY dosing approved beyond 12 months
The approval follows Astellas' resubmission of the supplemental New Drug Application (sNDA) for IZERVAY on December 26, 2024, within days of meeting with the FDA to clarify the Agency's feedback provided in the Complete Response Letter (CRL) issued in November 2024.
Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma
"We are pleased with the FDA's decision to extend the use of IZERVAY for longer-term administration—further solidifying IZERVAY's status as a trusted choice for thousands of GA patients since its launch in 2023. To date, IZERVAY remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies."
The approved label update was based on positive results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of IZERVAY through year 2.
Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the
Veeral S. Sheth, MD, MBA, FACS, FASRS, Partner and Director of Clinical Trials University Retina
"This is a welcome update for retina specialists, providing continued management options for treatment of this chronic, progressive disease that can lead to irreversible vision loss."
The GATHER2 study demonstrated that IZERVAY continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. The treatment benefit with IZERVAY versus sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1.
IZERVAY was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over 2 years, the incidence of choroidal neovascularization was slightly increased between IZERVAY (
IZERVAY was approved by the
The impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor.
About IZERVAY™ (avacincaptad pegol intravitreal solution)
What is IZERVAY?
IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD).
What is the most important information I should know about IZERVAY?
Do NOT receive IZERVAY if you:
- Have an infection in or around your eye
- Have active swelling in or around your eye that may include pain and redness
IZERVAY can cause serious side effects:
- Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).
- Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.
- There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.
- IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection.
Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:
- Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
- Have high pressure in the eye or if you have glaucoma.
- Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.
What should I avoid while receiving IZERVAY?
- Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.
What are the most common side effects of IZERVAY?
- Blood in the white of the eye
- Increase in eye pressure
- Blurred vision
- Wet age-related macular degeneration
These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for more information.
About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.
About the GATHER2 Clinical Trial
GATHER2 (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). IZERVAY is continuing to be evaluated in an open-label extension study.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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SOURCE Astellas Pharma Inc.
FAQ
What is the new FDA approval for IZERVAY (ALPMY) in February 2025?
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