Lund, Sweden - April 25, 2025: Camurus has announced a major regulatory milestone as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Oczyesa (CAM2029). This once-monthly treatment is designed for adult patients living with acromegaly, a rare hormonal disorder.
The recommendation is based on strong results from seven clinical trials, including two pivotal Phase 3 studies. These trials demonstrated that Oczyesa was more effective than current standard treatments in helping patients achieve normalized levels of insulin-like growth factor 1 (IGF-1), which is key to controlling the condition.
Patients also experienced improved symptom control, better quality of life, and greater treatment satisfaction over 52 weeks.
A Patient-Friendly Treatment Approach
Oczyesa is a long-acting octreotide formulation that is self-administered subcutaneously using an autoinjector pen. This delivery method offers increased convenience and independence for patients. According to Camurus, the drug increases octreotide plasma exposure compared to conventional options, which may lead to more consistent and reliable symptom control.
The treatment is built on Camurus’ proprietary FluidCrystal® drug delivery technology, designed for long-acting release and sustained therapeutic effect. Oczyesa has received orphan drug designation in the European Union for acromegaly, as well as for polycystic liver disease in both the EU and United States.
Camurus CEO Highlights the Significance of CHMP Recommendation
Fredrik Tiberg, President and CEO of Camurus, welcomed the CHMP’s positive opinion and highlighted the potential of Oczyesa to improve the lives of people with acromegaly.
“We are very pleased with the CHMP recommendation. Oczyesa has the potential to offer more convenient and effective treatment for patients who currently rely on complex or frequent injection schedules,” Tiberg said.
Understanding Acromegaly
Acromegaly is a rare and serious disease caused by a benign tumor in the pituitary gland, which leads to the overproduction of growth hormone and elevated IGF-1 levels. This hormonal imbalance causes abnormal tissue growth, joint pain, facial changes, and other complications that can significantly impair quality of life.
Next Steps and Market Implications
The CHMP’s recommendation will now move to the European Commission for a final decision, which is expected by mid-2025. If approved, Oczyesa will be authorized for marketing in all EU member states, bringing a much-needed option to patients and healthcare providers.
Camurus, a Swedish biopharmaceutical company, focuses on developing and delivering long-acting treatments for severe and chronic conditions. With a market capitalization of approximately $56 million, the company has shown resilience in recent months, maintaining a stable share price despite market volatility.
Reported Side Effects
During clinical trials, Oczyesa was generally well-tolerated. However, the most common side effects reported were related to the gastrointestinal system, nervous system, liver, and metabolism, as well as mild injection site reactions.
How Camurus’ Oczyesa Will Help Pharma Companies and the Pharmaceutical Industry
The positive opinion for Oczyesa marks more than just a regulatory win for Camurus. It also reflects a broader trend that could reshape how pharmaceutical companies approach rare disease treatment, drug delivery innovation, and patient care.
Here’s how this approval can benefit the pharma industry:
1. Stronger Focus on Rare Disease Markets
Oczyesa targets acromegaly, a rare and chronic condition. Its success highlights the growing opportunity for pharma companies to focus on orphan diseases. These markets may be smaller, but they often come with:
-
Less competition
-
Faster regulatory pathways
-
Higher pricing potential
As more companies follow this model, we can expect an increase in drug development for underserved conditions.
2. Shift Toward Long-Acting Drug Delivery
The drug uses Camurus’ FluidCrystal® technology, which allows for long-acting, sustained release with monthly injections. This sets a new standard in convenience and adherence. Pharma companies can:
-
Reduce dosing frequency
-
Improve treatment outcomes
-
Boost patient satisfaction and retention
This trend could encourage broader adoption of self-administered, long-acting formulations in various therapeutic areas.
3. Growing Role of Autoinjectors in Treatment Models
Oczyesa’s use of an autoinjector pen aligns with the global move toward home-based care and patient independence. For pharmaceutical companies, this means:
-
Lower burden on healthcare systems
-
Easier distribution and supply logistics
-
Potential for increased access in remote or resource-limited settings
4. Encouragement for Platform Technologies
Camurus’ proprietary platform has proven effective in multiple indications. This success can inspire more companies to invest in platform-based R&D, allowing them to:
-
Apply the same delivery system to multiple drugs
-
Speed up development timelines
-
Maximize return on investment
5. Potential growth to Investor Confidence
Regulatory approvals in rare diseases and drug delivery innovation tend to attract more investor interest. A product like Oczyesa can:
-
Improve the valuation of small and mid-sized biotech firms
-
Increase merger and acquisition interest from large pharma companies
-
Open up new licensing and co-commercialization opportunities
In summary, Oczyesa is more than just a treatment for acromegaly. It represents a shift in how the pharmaceutical industry can address rare diseases with smarter delivery systems and patient-centered design.
This model sets a roadmap for innovation, efficiency, and better patient care across the industry.
Reference:
- https://www.camurus.com/media/press-releases/2025/camurus-oczyesa-receives-marketing-authorization-for-treatment-of-acromegaly-in-the-eu/
- https://www.camurus.com/media/press-releases/2025/chmp-recommends-approval-of-oczyesa-for-treatment-of-acromegaly-in-the-eu/
