Camurus' Oczyesa® receives marketing authorization for treatment of acromegaly in the EU
Camurus (NASDAQ STO: CAMX) has received European Commission marketing authorization for Oczyesa®, a first-of-its-kind subcutaneous, once-monthly octreotide treatment for adult patients with acromegaly who have responded to and tolerated somatostatin analog treatment.
The approval is supported by a comprehensive clinical program including seven clinical studies, with two Phase 3 trials. The ACROINNOVA 1 study showed significantly higher normalization of insulin growth-factor-1 (IGF-1) levels compared to placebo, while ACROINNOVA 2 demonstrated sustained IGF-1 control and symptom reduction over 52 weeks versus standard of care.
Oczyesa® utilizes Camurus' FluidCrystal® technology and is designed for self-administration through a pre-filled autoinjector pen. The treatment addresses a market of approximately 70,000 patients living with acromegaly in the EU.
Camurus (NASDAQ STO: CAMX) ha ottenuto l'autorizzazione all'immissione in commercio dalla Commissione Europea per Oczyesa®, un trattamento sottocutaneo innovativo a somministrazione mensile di octreotide destinato agli adulti con acromegalia che hanno risposto e tollerato la terapia con analoghi della somatostatina.
L'approvazione si basa su un programma clinico completo che comprende sette studi clinici, di cui due studi di Fase 3. Lo studio ACROINNOVA 1 ha evidenziato una normalizzazione significativamente superiore dei livelli di fattore di crescita insulino-simile 1 (IGF-1) rispetto al placebo, mentre ACROINNOVA 2 ha dimostrato un controllo stabile dell’IGF-1 e una riduzione dei sintomi per 52 settimane rispetto alla terapia standard.
Oczyesa® utilizza la tecnologia FluidCrystal® di Camurus ed è progettato per l'autosomministrazione tramite una penna autoiniettabile pre-riempita. Il trattamento si rivolge a un mercato di circa 70.000 pazienti affetti da acromegalia nell'UE.
Camurus (NASDAQ STO: CAMX) ha recibido la autorización de comercialización de la Comisión Europea para Oczyesa®, un tratamiento subcutáneo mensual de octreótido, único en su tipo, para pacientes adultos con acromegalia que han respondido y tolerado el tratamiento con análogos de la somatostatina.
La aprobación está respaldada por un programa clínico integral que incluye siete estudios clínicos, con dos ensayos de Fase 3. El estudio ACROINNOVA 1 mostró una normalización significativamente mayor de los niveles del factor de crecimiento similar a la insulina 1 (IGF-1) en comparación con el placebo, mientras que ACROINNOVA 2 demostró un control sostenido del IGF-1 y reducción de síntomas durante 52 semanas frente al tratamiento estándar.
Oczyesa® utiliza la tecnología FluidCrystal® de Camurus y está diseñado para la autoadministración mediante un autoinyector precargado. El tratamiento está dirigido a un mercado de aproximadamente 70,000 pacientes que viven con acromegalia en la UE.
Camurus (NASDAQ STO: CAMX)는 유럽연합 집행위원회로부터 Oczyesa®에 대한 판매 허가를 받았습니다. Oczyesa®는 소마토스타틴 유사체 치료에 반응하고 내성을 보인 성인 말단비대증 환자를 위한 최초의 월 1회 피하주사 옥트레오타이드 치료제입니다.
이번 승인은 두 건의 3상 임상시험을 포함한 7건의 임상 연구를 포함한 종합적인 임상 프로그램을 기반으로 합니다. ACROINNOVA 1 연구에서는 위약 대비 인슐린 유사 성장인자-1(IGF-1) 수치 정상화가 유의하게 높았으며, ACROINNOVA 2 연구는 표준 치료 대비 52주간 IGF-1 조절과 증상 감소가 지속됨을 입증했습니다.
Oczyesa®는 Camurus의 FluidCrystal® 기술을 활용하며, 사전 충전된 자동주사기 펜을 통해 환자 스스로 투여할 수 있도록 설계되었습니다. 이 치료제는 EU 내 약 70,000명의 말단비대증 환자를 대상으로 합니다.
Camurus (NASDAQ STO : CAMX) a obtenu l'autorisation de mise sur le marché de la Commission européenne pour Oczyesa®, un traitement sous-cutané mensuel novateur à base d'octréotide destiné aux patients adultes atteints d'acromégalie ayant répondu et toléré un traitement par analogues de la somatostatine.
Cette approbation repose sur un programme clinique complet comprenant sept études cliniques, dont deux essais de phase 3. L'étude ACROINNOVA 1 a montré une normalisation significativement plus élevée des niveaux du facteur de croissance insulinomimétique 1 (IGF-1) par rapport au placebo, tandis que l'étude ACROINNOVA 2 a démontré un contrôle soutenu de l’IGF-1 et une réduction des symptômes sur 52 semaines par rapport au traitement standard.
Oczyesa® utilise la technologie FluidCrystal® de Camurus et est conçu pour une auto-administration via un stylo auto-injecteur prérempli. Ce traitement s'adresse à un marché d'environ 70 000 patients vivant avec l'acromégalie dans l'UE.
Camurus (NASDAQ STO: CAMX) hat von der Europäischen Kommission die Marktzulassung für Oczyesa® erhalten, eine neuartige subkutane monatliche Octreotid-Behandlung für erwachsene Patienten mit Akromegalie, die auf eine Behandlung mit Somatostatin-Analoga angesprochen haben und diese vertragen.
Die Zulassung stützt sich auf ein umfassendes klinisches Programm mit sieben klinischen Studien, darunter zwei Phase-3-Studien. Die ACROINNOVA 1-Studie zeigte eine signifikant höhere Normalisierung der Insulinähnlichen Wachstumsfaktor-1 (IGF-1)-Spiegel im Vergleich zu Placebo, während ACROINNOVA 2 eine anhaltende IGF-1-Kontrolle und Symptomreduktion über 52 Wochen gegenüber der Standardtherapie nachwies.
Oczyesa® verwendet die FluidCrystal®-Technologie von Camurus und ist für die Selbstanwendung mittels eines vorgefüllten Autoinjektor-Pens konzipiert. Die Behandlung richtet sich an einen Markt von etwa 70.000 Patienten mit Akromegalie in der EU.
- None.
- Common side effects include gastrointestinal, nervous system, and hepatobiliary disorders
- Limited to patients who have already responded to and tolerated somatostatin analogs
- Requires monthly injection site administration
Insights
Camurus received EU approval for Oczyesa, a first-of-its-kind once-monthly acromegaly treatment, expanding their commercial portfolio in rare diseases.
The European Commission has granted marketing authorization to Camurus for Oczyesa®, representing a significant regulatory milestone for the company. This newly approved therapy offers the first subcutaneous, once-monthly octreotide option for maintenance treatment of acromegaly in adults who have responded to and tolerated somatostatin analogs.
The clinical foundation for this approval is substantial, with data from seven clinical studies including two Phase 3 trials. The ACROINNOVA clinical program demonstrated that Oczyesa produced normalized insulin growth-factor-1 (IGF-1) levels - the key biomarker for acromegaly control - at significantly higher rates than placebo. The 52-week extension study confirmed persistence of these results while showing improvements in symptoms, quality of life, and treatment satisfaction compared to standard care.
What differentiates Oczyesa in the treatment landscape is its patient-friendly administration. Formulated using Camurus' proprietary FluidCrystal® technology, the product enables convenient self-administration via a pre-filled autoinjector with a hidden, thin needle. This represents a meaningful advancement for patients managing this chronic condition.
Acromegaly, affecting approximately 70,000 people in the EU, is characterized by excessive growth of bone and tissue due to overproduction of growth hormone. Patients experience numerous symptoms including fatigue, joint pain, and enlarged features, with potential complications of reduced quality of life and increased mortality risk if left uncontrolled.
The common side effects observed include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions - a profile that will factor into treatment decisions by physicians and patients.
- First subcutaneous, once-monthly octreotide for treatment of acromegaly
- For convenient self-administration with a pre-filled autoinjector pen
"Oczyesa is the first approved once-monthly, subcutaneous octreotide treatment for patients with acromegaly", says Fredrik Tiberg, President & CEO, CSO at Camurus. "We look forward to making this new treatment option, designed for convenient self-administration, available to eligible patients in the EU as soon as possible."
Acromegaly is a rare, serious, and chronic disease characterized by excessive growth of bone and tissue, resulting in enlarged hands, feet, facial features, and inner organs. Symptoms include fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.2 Patients with uncontrolled acromegaly often experience reduced quality of life and increased mortality risk.3,4 An estimated 70,000 people in the EU are living with acromegaly.5
"Oczyesa is a welcome new treatment option for patients with acromegaly, providing effective disease control and enabling convenient self-administration by patients", says Dr Diego Ferone, Professor in Endocrinology, Head of Department of Internal Medicine at the Ospedale Policlinico San Martino, University of
The marketing authorization of Oczyesa is based on the results from a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. Furthermore, the study showed improvements in symptoms, quality of life, and treatment satisfaction scores after 52 weeks of treatment with Oczyesa compared to standard of care (SoC) at baseline.6,7 The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.1
Oczyesa is formulated using Camurus' proprietary FluidCrystal® technology. The product is designed for easy and convenient once-monthly, subcutaneous self-administration using a pre-filled autoinjector pen with a hidden, thin needle.
*dated 30 June, 2025.
For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com
About acromegaly
Acromegaly is a rare, progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.2 Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.3,4 The prevalence of acromegaly is estimated to about 60 cases per million.8
About Oczyesa® (CAM2029)
Oczyesa® (CAM2029) is a ready-to-use, long-acting subcutaneous depot of octreotide indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1 The product is stored at room temperature and should not be refrigerated.
The CAM2029 clinical program for acromegaly comprises of seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.9 In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to standard-of-care (SoC) at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 was consistent with SoC with no new findings.6,7
CAM2029 is under development for two additional chronic and severe disease indications: gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
About Camurus
Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across
References
- Oczyesa® SmPC.
- Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.
- Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
- Fleseriu M., et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826.
- https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1671
- Ferone, D., et al. J Clin Endocrinol Metab. Published 8 October, 2024.
- Press release 15 July, 2024: https://www.camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients/
- Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.
- Summary of Product Characteristics, Sandostatin LAR 20 mg: https://assets.hpra.ie/products/Human/22656/Licence_PA0896-028-005_03012024152159.pdf
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 11.30 am CET on 1 July 2025.
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FAQ
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