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Press release

Camurus launches long-acting Oczyesa® for the treatment of acromegaly

03 November 2025
  • Oczyesa now available to patients with acromegaly in Germany
  • First once-monthly, subcutaneous octreotide treatment
  • Developed for self-administration and effective disease control

Lund, Sweden — 3 November 2025 — Camurus (NASDAQ STO: CAMX) today announced the introduction of Oczyesa in Germany, as the first country in the EU. Oczyesa®, octreotide subcutaneous depot, is approved for the maintenance treatment in adults with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1

”We are pleased to announce that Oczyesa is now available to patients with acromegaly, following marketing authorization by the European Commission”, says Fredrik Tiberg, President & CEO, CSO of Camurus. “The medication provides sustained disease control and can be self-administered using an autoinjector pen, enhancing patients’ quality of life and treatment satisfaction. Oczyesa is introduced first in Germany, with subsequent launches planned across additional EU countries.”

Acromegaly is a rare and chronic disease characterized by excessive bone and tissue growth, and disease symptoms, such as fatigue, joint pain, visual field defects, and sweating.2 Patients with uncontrolled acromegaly have reduced quality of life and increased mortality risk.3,4 An estimated 70,000 people in the EU are living with acromegaly.5

“There remains a significant unmet medical need among patients with acromegaly, who often face a substantial treatment burden and reduced quality of life”, says Prof. Günter Stalla, Head of Medicover Neuroendocrinology, Munich, Germany. “Oczyesa offers a welcome new alternative, combining effective disease control with the convenience of self-administration. This empowers patients and supports optimizing healthcare resources.”  

Oczyesa is based on Camurus’ FluidCrystal® technology and is designed for easy self-administration by the patient using an autoinjector pen. Clinical studies have shown that Oczyesa provides sustained biochemical control and symptom relief in patients with acromegaly who previously were on standard treatment with first-generation long-acting somatostatin receptor ligands (SRLs). Patients treated with Oczyesa reported improved quality of life and treatment satisfaction compared to standard of care at the start of the study. The treatment was well tolerated, with a safety profile consistent with standard of care with first-generation SRLs.6,7

For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
[email protected]

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
[email protected]

About acromegaly
Acromegaly is a rare, slowly 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 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 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. The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.6,7

CAM2029 (Oczyesa) was granted marketing authorization for acromegaly in the EU by the European Commission on 30 June 2025 and in the UK by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on 28 August 2025.

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 Europe, the US, and Australia, with headquarters in Lund, Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn.

References

  1. Oczyesa® SmPC.
  2. Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.
  3. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
  4. Fleseriu M, et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826.
  5. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1671
  6. Ferone, D., et al. J Clin Endocrinol Metab. Published 8 October, 2024.
  7. 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/  
  8. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.
  9. Prescribing Information SANDOSTATIN® LAR: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf 

This information was submitted for publication at 8.00 am CET on 3 November 2025.

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