Sweden-based biopharmaceutical company Camurus AB (NASDAQ STO: CAMX) announced on Tuesday that it has received marketing authorisation from the European Commission for Oczyesa (CAM2029), a once-monthly, subcutaneous octreotide depot indicated for the maintenance treatment of adult patients with acromegaly who have previously responded to somatostatin analogues.

Oczyesa is the first approved once-monthly subcutaneous treatment of its kind and is designed for self-administration via a pre-filled autoinjector pen using Camurus' FluidCrystal technology.

The approval is based on data from seven clinical studies, including two Phase 3 trials in the ACROINNOVA program, which demonstrated superior biochemical control, improved symptom management, and enhanced quality of life compared to baseline standard-of-care treatments. The most common adverse events discovered during the studies included gastrointestinal, nervous system, hepatobiliary, and injection site disorders.

In ACROINNOVA 1, Oczyesa significantly increased the proportion of patients achieving normalised insulin growth factor-1 (IGF-1) levels versus placebo, with sustained efficacy over 52 weeks confirmed in ACROINNOVA 2.

Approximately 70,000 individuals in the European Union are affected by acromegaly, a chronic and rare disease linked to excess growth hormone and IGF-1 levels.

Camurus is also developing Oczyesa for gastroenteropancreatic neuroendocrine tumours and polycystic liver disease.