EYLEA HD® (aflibercept) 8 mg Data at EURETINA Show Long-term Durability, Fluid Control, and Safety

Regeneron Pharmaceuticals, Inc. has unveiled new findings regarding EYLEA HD (aflibercept) Injection 8 mg and EYLEA (aflibercept) Injection 2 mg at the Annual Meeting of the European Society of Retina Specialists (EURETINA) in Barcelona. These findings emphasize EYLEA HD's efficacy in managing wet age-related macular degeneration (wAMD) and diabetic macular edema, showcasing its potential to become a new standard of care.

Three post-hoc analyses from the PULSAR trial for wAMD were highlighted in the presentations. These analyses included an evaluation of disease activity criteria from faricimab Phase 3 trials applied to EYLEA HD, examining how these criteria might influence decisions on dosing intervals. Another analysis focused on EYLEA HD's ability to maintain fluid control over two years, with measurements based on central retinal thickness and best-corrected visual acuity. The third analysis assessed the safety profile of EYLEA HD, specifically looking at intraocular pressure outcomes through the 96-week mark.

Additionally, data from the PHOTON trial in diabetic macular edema and a pooled safety analysis across the CANDELA, PHOTON, and PULSAR trials were presented. This comprehensive analysis underscores the consistent safety and efficacy of EYLEA HD.

Regeneron, in collaboration with Bayer AG, has been developing EYLEA HD, which is marketed as Eylea™ 8 mg in the EU and Japan. In the U.S., Regeneron holds exclusive marketing rights, while Bayer manages marketing outside the U.S., with profits shared equally post-regulatory approvals.

The meeting featured several key presentations:

1. Jean-Francois Korobelnik presented findings from a 96-week PULSAR subgroup analysis, which indicated similar visual and anatomical improvements for patients receiving aflibercept 8 mg every 12 weeks or more extended intervals compared to those receiving 2 mg every 8 weeks.
2. Paolo Lanzetta discussed intraocular pressure outcomes for patients with neovascular age-related macular degeneration treated with aflibercept 8 mg and 2 mg through Week 96 of the PULSAR trial.
3. Michael Stewart presented a post-hoc analysis comparing the timing and magnitude of disease control with aflibercept 8 mg and faricimab in Phase 3 trials for nAMD.
4. Praveen J Patel's analysis highlighted rapid and sustained fluid control with aflibercept 8 mg, stratified by baseline central retinal thickness and best-corrected visual acuity.

Other notable presentations included data on the impact of baseline central retinal thickness on vision in patients with diabetic macular edema from the PHOTON trial and a pooled safety analysis demonstrating comparable safety profiles for aflibercept 8 mg and 2 mg across the CANDELA, PHOTON, and PULSAR trials.

The EYLEA HD clinical trial program includes the PULSAR trial for wAMD and the PHOTON trial for DME/diabetic retinopathy, both double-masked and active-controlled pivotal trials conducted globally. Patients were randomized to receive either EYLEA HD every 12 or 16 weeks or EYLEA every 8 weeks. Patients treated with EYLEA HD had their dosing intervals adjusted based on disease progression criteria, whereas EYLEA groups maintained fixed 8-week intervals.

Regeneron has been a pioneer in the field of ophthalmology, significantly impacting the treatment of retinal diseases with its vascular endothelial growth factor (VEGF) inhibitor, EYLEA. The company continues to innovate with EYLEA HD, aiming to extend injection intervals while maintaining the efficacy and safety observed with EYLEA.

For more than a decade, EYLEA has transformed retinal disease treatment, supported by extensive research, clinical trials, and over 70 million injections globally. Regeneron remains committed to advancing eye care with new solutions to offer greater flexibility for patients and healthcare providers.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!