Camurus' Oczyesa® Approved for Acromegaly Treatment in EU

LUND, Sweden, July 1, 2025 – Camurus has announced that the European Commission (EC) has approved Oczyesa® (CAM2029), a subcutaneous depot of octreotide, for the treatment of adult patients with acromegaly who have shown positive response and tolerance to somatostatin analogs. Oczyesa is the first once-monthly subcutaneous treatment for acromegaly, aimed at enabling patient self-administration.

Acromegaly is a rare and chronic disorder caused by excessive growth hormone, often due to a pituitary gland tumor. This leads to enlarged features such as hands, feet, and facial structures, and affects inner organs as well. Symptoms include fatigue, joint pain, and vision disturbances, impacting life quality and increasing mortality risk. Approximately 70,000 individuals in the EU are affected by this condition.

Professor Diego Ferone, an endocrinologist at the Ospedale Policlinico San Martino, University of Genova, Italy, has emphasized the benefits of Oczyesa in managing acromegaly. This new treatment offers effective disease control and allows for patient-friendly self-administration. The ACROINNOVA program's clinical trials demonstrate Oczyesa's ability to provide enduring biochemical response and improved symptom management compared to standard treatments.

Oczyesa's marketing authorization is supported by an extensive clinical program comprising seven studies, including two Phase 3 trials. The ACROINNOVA 1 study revealed that Oczyesa significantly increases the number of patients achieving normalized insulin-like growth factor-1 (IGF-1) levels compared to placebo. The ACROINNOVA 2 study confirmed the persistence of normalized IGF-1 levels and symptom reduction over 52 weeks. Additionally, improvements in symptoms, quality of life, and treatment satisfaction were observed after a year of treatment with Oczyesa in comparison to initial standard treatments.

Common side effects reported include gastrointestinal and nervous system disorders, metabolism and nutritional imbalances, hepatobiliary issues, and injection site reactions. Oczyesa utilizes Camurus’ proprietary FluidCrystal® technology, making it suitable for easy monthly self-administration through a pre-filled autoinjector pen.

Acromegaly results from heightened levels of growth hormone and IGF-1, usually due to a pituitary gland tumor. It involves abnormal growth of bones and tissues, manifesting in enlarged physical features and causing various symptoms like fatigue and vision problems. The prevalence of acromegaly stands at approximately 60 cases per million people.

Oczyesa (CAM2029) serves as a long-acting, subcutaneous depot of octreotide for adults with acromegaly who have responded well to somatostatin analogs. The product can be stored at room temperature and doesn't require refrigeration. The clinical program includes seven trials, showing a five-fold higher bioavailability compared to previously approved long-acting intramuscular octreotide.

The Phase 3 ACROINNOVA program demonstrated the superior biochemical control offered by CAM2029 compared to placebo and improvements in symptom control, treatment satisfaction, and quality of life versus standard care. The safety profile of CAM2029 aligns with existing treatments without introducing new safety concerns. Moreover, CAM2029 is under investigation for other severe disease indications including gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).

Camurus is a biopharmaceutical company based in Lund, Sweden, focusing on innovative, long-acting medicines for severe and chronic diseases. Utilizing FluidCrystal® technology, Camurus aims to develop products with best-in-class potential across various therapeutic areas. The company’s operations span Europe, the US, and Australia, with its shares traded on Nasdaq Stockholm under the ticker CAMX.