EMA's CHMP Recommends Approval of Novartis' Jetrea for Vitreomacular Traction Treatment
Key Insights
Novartis' eye care division Alcon receives positive CHMP opinion for Jetrea (ocriplasmin) to treat vitreomacular traction (search) and associated macular holes in European patients.
The innovative treatment addresses an unmet need for 250,000-300,000 European patients with VMT, offering an alternative to the current 'watchful waiting' approach before late-stage surgery.
Following FDA approval in October 2012, Europe is set to become the first region outside the US to approve Jetrea, marking a significant advancement in retinal therapy.
Novartis' eye care division Alcon has achieved a significant milestone as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Jetrea (ocriplasmin). The drug is indicated for treating vitreomacular traction (search) (VMT), including cases with macular holes up to 400 microns in diameter.
Understanding VMT and Current Treatment Landscape
Vitreomacular traction (search) is an age-related progressive condition that poses a serious threat to vision. Without proper treatment, patients may experience visual distortion, decreased visual acuity, and potentially central blindness. Current estimates suggest that 250,000 to 300,000 European patients are affected by this sight-threatening condition.
The existing treatment paradigm in the EU has been limited to "observation" or "watchful waiting" until patients deteriorate enough to require surgical intervention. This approach has left many patients without viable treatment options during the early stages of the disease.
Clinical Impact and Patient Benefits
"Jetrea represents an important breakthrough for both patients and retinal specialists and represents a paradigm-shift in this area of retinal therapy and clinical practice," states Professor Yit Yang, Consultant Ophthalmologist at Royal Wolverhampton Eye Hospital and Visiting Professor at Aston University, UK.
The impact of VMT and macular holes on patients' daily lives is substantial. According to clinical experts, activities such as reading, driving, working, using computer screens, and overall quality of life are significantly affected by the condition.
Commercial Development and Global Expansion
Dr. Sabri Markabi, Senior Vice President of Research and Development at Alcon, emphasized the company's commitment to addressing unmet eye care needs: "We are excited to bring this innovative treatment to patients in Europe who live with VMT and macular hole (search) and for whom there has been limited prospect of treatment."
The drug's global rollout follows its successful FDA approval in October 2012 for symptomatic vitreomacular adhesion (search) (VMA) in the United States, where ThromboGenics launched the product in January 2013. Through a strategic partnership, Novartis' Alcon acquired the rights to commercialize Jetrea outside the United States from ThromboGenics, while the Belgian biopharmaceutical company maintains US commercialization rights.