“Oczyesa XR gives people with acromegaly lasting disease control with a convenient once-monthly dose that can be taken at home with an injection pen, instead of depending on clinic visits. We look forward to launching Oczyesa XR in Canada and making the treatment available to Canadian patients,” says Fredrik Tiberg, President and CEO, Camurus.

The approval is based on a comprehensive clinical program of seven studies, including the two Phase 3 trials ACROINNOVA 1 and ACROINNOVA 2. In the placebo-controlled ACROINNOVA 1 study, a significantly larger proportion of patients treated with Oczyesa achieved normalized IGF-1 levels compared with placebo. ACROINNOVA 2 confirmed sustained normalization of IGF-1 levels, reduced disease symptoms, and improved quality of life over 52 weeks of treatment. Patients also reported higher treatment satisfaction compared with their previous standard treatment. The safety profile was comparable to that of established somatostatin analogs.

The Lund-based company has previously received marketing approval for the product in the EU, the UK, and Australia under the brand name Oczyesa.