Salute e Benessere
Camurus' Oczyesa® receives marketing authorization for treatment of acromegaly in the EU
Acromegaly is a rare, serious, and chronic disease characterized by excessive growth of bone and tissue, resulting in enlarged hands, feet, facial features, and inner organs. Symptoms include fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia. Patients with uncontrolled acromegaly often experience reduced quality of life and increased mortality risk. An estimated 70,000 people in the EU are living with acromegaly.
"Oczyesa is a welcome new treatment option for patients with acromegaly, providing effective disease control and enabling convenient self-administration by patients", says Dr Diego Ferone , Professor in Endocrinology, Head of Department of Internal Medicine at the Ospedale Policlinico San Martino, University of Genova, Italy , and coordinating investigator of the ACROINNOVA program. "Results from the ACROINNOVA clinical program have shown that Oczyesa provides effective and durable biochemical treatment response, as well as improved acromegaly symptom control and quality of life compared to current standard treatment."
The marketing authorization of Oczyesa is based on the results from a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. 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.
Oczyesa is formulated using Camurus' proprietary FluidCrystal technology. The product is designed for easy and convenient once-monthly, subcutaneous self-administration using a pre-filled autoinjector pen with a hidden, thin needle.
*dated 30 June, 2025 .
Fredrik Tiberg , President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 11.30 am CET on 1 July 2025 .
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