Bayer Submits Application to EMA for 6-Month Dosing Interval of Eylea™ 8 mg in nAMD and DME

Feb 18, 2025 10:27 CST Updated 10:27

Bayer

Pharmaceutical Product R&D Developer

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At the 22nd Annual Angiogenesis Meeting held in Miami, United States, Bayer and its partner Regeneron announced the three-year clinical trial results of the PULSAR open-label extension study. The study evaluated the long-term efficacy, safety, and durability of Eylea™ 8mg (aflibercept 8mg, 114.3mg/ml injection) for the treatment of neovascular (wet) age-related macular degeneration (nAMD). The data shows,Eylea™ 8mg Demonstrates Sustained Vision Improvement and Fluid Control Over Three Years with a Favorable Safety Profile.

The study results showed that patients receiving Eylea™ 8mg maintained a significant reduction in central retinal thickness (CRT) over three years. At the end of the third year, the vast majority of patients had their last dosing interval reach or exceed three months.40% of patients have intervals reaching or exceeding 5 months,24% of patients had an interval of up to 6 months.Eylea™ 8mg demonstrated consistently good safety over three years, aligning with the safety profile of Eylea® 2mg, with no new safety signals identified.

Based on these positive data, Bayer has submitted an application to the European Medicines Agency (EMA) to extend the treatment interval of Eylea™ 8mg for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) to up to 6 months.This application is based on the three-year treatment results of the open-label extension studies PULSAR (nAMD) and PHOTON (DME). In the PHOTON study, 28% of DME patients and 24% of nAMD patients reached a dosing interval of six months at the end of three years.

The PULSAR extension study aims to evaluate the long-term efficacy, safety, and durability of Eylea™ 8mg in treating nAMD patients from Week 96 to Week 156. The study showed that 90.2% of patients completed the study, with Eylea™ 8mg continuing to demonstrate favorable efficacy and safety over three years. The PHOTON study further confirmed the long-term efficacy and safety of Eylea™ 8mg in DME patients.

Christine Roth, Member of the Bayer Prescription Medicines Leadership Team, Executive Vice President and Head of Global Product Strategy and Commercialization, said: "With the aging population and the rising prevalence of wet age-related macular degeneration, there is an urgent need for more durable treatment options.The long-term results of Eylea™ 8mg demonstrate its significant potential in meeting the needs of patients, caregivers, and ophthalmologists. Longer treatment intervals not only address critical medical needs but also offer patients greater flexibility, reducing the burden of frequent injections and clinic visits.”

Bayer stated in the press release,Eylea™ 8mg is currently the only anti-vascular endothelial growth factor (VEGF) treatment approved in the EU, UK, and other markets for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) with dosing intervals of up to 5 months. Long-term data show that Eylea™ 8mg offers efficacy and safety comparable to the current standard treatment, Eylea® 2mg, while reducing the treatment burden.

Neovascular (wet) age-related macular degeneration (nAMD) is a rapidly progressing eye disease that can lead to irreversible vision loss. Globally, approximately 170 million people are affected by AMD, and this number is expected to increase to 288 million by 2040. Diabetic macular edema (DME) is a common complication in diabetic patients, impacting around 27 million people worldwide.

Eylea™ 8mg, jointly developed by Bayer and Regeneron, is exclusively licensed to Regeneron in the United States for Eylea® (Aflibercept 2mg) and Eylea™ HD, while Bayer holds exclusive marketing rights outside the U.S. Eylea™ 8mg has been approved in over 50 markets worldwide for the treatment of nAMD and DME, with further registration applications ongoing. As a key product in anti-VEGF therapy for retinal diseases, Eylea® has been used in more than 85 million cases and treated over 12 million patients globally.

References:

[1] Bayer Press Release

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