Bayer Eylea 8 mg with extended 6-month treatment interval approved in EU for retinal diseases
Berlin: Bayer has received approval from the European Commission (EC) for a label extension in the European Union (EU) for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).
Eylea 8 mg is a anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME.
“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy,” stated Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “This translates to decreased burden of disease for patients and may enhance adherence to treatment. For ophthalmologists, it allows for greater capacity to treat additional patients. Given its distinctive product profile, Eylea 8 mg has the potential to establish a new standard of care for retinal diseases.”
The EC decision is based on additional positive results from the third year open-label extension phase of the pivotal clinical trials PULSAR in nAMD and PHOTON in DME. In both extension phases (study weeks 96-156), patients originally randomized to Eylea 8 mg at week 0 maintained their visual and anatomic improvements, with 24% of patients in nAMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of three years.
The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including for patients switching from Eylea 2 mg to Eylea 8 mg at week 96. The rates for ocular treatment emergent adverse events were similar across all treatment groups.
Eylea 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.
Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 89 million applications and more than 13 million patient-years of experience worldwide.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.
Diabetic macular edema (DME) is a common complication in the eyes of people living with diabetes. DME occurs when high levels of blood sugar leads to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME affects around 27 million people globally.
