Swedish biopharmaceutical company Camurus AB (STO: CAMX) on Monday said it has received a Notice of Compliance from Health Canada for Oczyesa XR, a long-acting subcutaneous octreotide depot for adults with acromegaly who have responded to somatostatin analogue treatment.
Oczyesa (CAM2029) is a ready-to-use, long-acting octreotide depot stored at room temperature. The drug has shown approximately five-fold higher bioavailability than approved long-acting intramuscular octreotide.
The decision is supported by seven clinical studies, including the Phase 3 ACROINNOVA 1 and ACROINNOVA 2 trials. ACROINNOVA 1 showed a significantly higher proportion of patients on Oczyesa achieving normalised IGF-1 levels versus placebo. ACROINNOVA 2 confirmed sustained IGF-1 normalisation, reduced symptoms, and improved quality of life over 52 weeks, with treatment satisfaction higher than previous standard-of-care therapies. The safety profile was comparable to established somatostatin receptor ligands.
CAM2029 received EU approval in June 2025, UK approval in August 2025, and Australian approval in August 2026. It is also in development for gastroenteropancreatic neuroendocrine tumours and polycystic liver disease.
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