- The first subcutaneous, once-monthly octreotide for acromegaly treatment, offering convenient self-administration via a pre-filled autoinjector pen.
LUND, Sweden, July 1, 2025 /PRNewswire/ — Camurus (NASDAQ STO: CAMX) announced today that the European Commission (EC) has granted marketing authorization for Oczyesa®, an octreotide subcutaneous depot formulation, for the maintenance treatment of adult acromegaly patients who have previously shown a positive response to and tolerated somatostatin analog therapy.
“Oczyesa represents a significant advancement, being the first approved treatment that allows patients with acromegaly to receive subcutaneous octreotide on a monthly basis,” stated Fredrik Tiberg, President & CEO, CSO at Camurus. “We are eager to make this new therapeutic option, designed for user-friendly self-administration, accessible to eligible patients across the EU in the shortest possible timeframe.”
Acromegaly, a rare yet serious chronic condition, is characterized by the overproduction of growth hormone, leading to the excessive growth of bone and soft tissues. This often manifests as enlarged hands, feet, distinctive facial features, and internal organ enlargement. Patients may also experience debilitating symptoms such as fatigue, joint pain, headaches, visual disturbances, excessive sweating, and paresthesia. Without proper management, uncontrolled acromegaly can significantly diminish a patient’s quality of life and elevate their risk of premature mortality. It is estimated that approximately 70,000 individuals in the European Union are living with this condition.
“Oczyesa is a highly anticipated and welcome addition to the treatment landscape for acromegaly patients, offering not only effective disease control but also the crucial benefit of convenient self-administration,” commented Dr. Diego Ferone, Professor of Endocrinology and Head of the Department of Internal Medicine at the Ospedale Policlinico San Martino, University of Genova, Italy, and coordinating investigator for the ACROINNOVA program. “The clinical data from the ACROINNOVA program has consistently demonstrated Oczyesa’s ability to achieve effective and sustained biochemical responses, alongside notable improvements in acromegaly symptom management and overall quality of life when compared to existing standard treatments.”
The marketing authorization for Oczyesa is underpinned by a robust clinical program encompassing seven studies, including two pivotal Phase 3 trials. Specifically, the ACROINNOVA 1 study revealed a significantly higher percentage of patients achieving normalized Insulin-like Growth Factor-1 (IGF-1) levels with Oczyesa compared to placebo. The ACROINNOVA 2 study further validated the durability of its therapeutic effect, confirming sustained mean IGF-1 levels and symptom reduction over a 52-week period. Importantly, this study also reported improvements in patient-reported outcomes, including symptom control, quality of life, and treatment satisfaction, after 52 weeks of Oczyesa administration, outperforming the baseline standard of care (SoC). Common side effects observed included gastrointestinal, nervous system, and hepatobiliary disorders, as well as metabolism and nutritional disturbances, and injection site reactions.
Oczyesa leverages Camurus’ proprietary FluidCrystal® technology to create a ready-to-use, long-acting subcutaneous depot formulation. The product is engineered for straightforward and convenient monthly self-administration, utilizing a pre-filled autoinjector pen with a discreet, fine needle.
*Authorization dated June 30, 2025.
About acromegaly
Acromegaly is a rare and progressive endocrine disorder, typically caused by a benign tumor of the pituitary gland that secretes excess growth hormone. This excess hormone drives elevated levels of insulin-like growth factor-1 (IGF-1), leading to abnormal bone and tissue growth, characteristic changes in facial features, and enlargement of hands, feet, and internal organs. Common symptoms include fatigue, joint pain, headaches, visual field impairments, excessive perspiration, and paresthesia. Inadequate control of biochemical markers and symptoms can significantly impair patients’ quality of life and increase mortality. The estimated prevalence of acromegaly is approximately 60 cases per million population.
About Oczyesa® (CAM2029)
Oczyesa® (CAM2029) is a ready-to-use, long-acting subcutaneous depot formulation of octreotide, indicated for the maintenance treatment of adult patients with acromegaly who have demonstrated a response to and tolerability of somatostatin analog therapy. The product is designed for room temperature storage, negating the need for refrigeration.
The clinical development program for CAM2029 in acromegaly includes seven clinical trials, comprising four Phase 1 studies, one Phase 2 study, and the two Phase 3 studies within the ACROINNOVA program. CAM2029 has demonstrated approximately five times greater bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide formulations. The Phase 3 ACROINNOVA program indicated superior biochemical control with CAM2029 relative to placebo, alongside notable improvements in symptom management, treatment satisfaction, and quality of life when compared to the baseline standard of care (SoC) with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 proved consistent with that of SoC, with no new safety concerns identified.
CAM2029 is also progressing in clinical development for two additional chronic and severe indications: gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
About Camurus
Camurus is a global, science-driven biopharmaceutical company dedicated to the development and commercialization of innovative, long-acting therapeutic solutions aimed at enhancing the lives of patients suffering from severe and chronic diseases. The company conceives novel drug products with best-in-class potential, leveraging its proprietary FluidCrystal® technology and extensive research and development expertise. Camurus’ R&D pipeline includes promising candidates for the treatment of addiction, pain, cancer, and endocrine disorders. With a reach extending across Europe, the United States, and Australia, Camurus is headquartered in Lund, Sweden. The company’s shares are traded on Nasdaq Stockholm under the ticker symbol CAMX. For further details, please visit www.camurus.com and LinkedIn.
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 October 8, 2024.
- Press release July 15, 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 announcement is information that Camurus AB is required to disclose under the EU Market Abuse Regulation. The information was released for publication via the managing director at 11:30 am CET on July 1, 2025.
This release was distributed by Cision http://news.cision.com
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