Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years – Bayer

Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PHOTON in patients with diabetic macular edema (DME) at three years, in a late-breaking session at the American Academy of Ophthalmology Annual Meeting, 18-21 October, Chicago, USA. The aim of the open-label extension study was to evaluate long-term efficacy, safety and durability of Eylea 8 mg in patients with diabetic macular edema (DME) from week 96 until week 156. Patients previously treated with Eylea 2 mg could be switched to Eylea 8 mg and were immediately assigned to a 12-week dosing interval (no initial monthly doses needed). Patients that have already been treated with Eylea 8 mg throughout week 96 continued their last assigned interval. Disease activity was monitored every 4 weeks through week 108, then monitoring continued every 12 weeks. Disease activity was assessed according to specified, clinically relevant disease regimen modification (DRM) criteria. In patients with no disease activity the treatment interval was extended by 2-week increments with a maximum interval of 24 weeks (6 months). In patients with disease activity the treatment interval was shortened by 2-week increments with a minimum interval of 8 weeks (2 months).

Patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements at the end of three years, with the vast majority of patients on extended dosing intervals of ≥ 3 months. 45% of patients had a last completed dosing interval of ≥ 5 months, and 25% completed a last dosing interval of 6 months at the end of three years. Notably, patients switched to Eylea 8 mg demonstrated substantially slower fluid reaccumulation after their first Eylea 8 mg dose, as compared to their previous rate of fluid reaccumulation with Eylea 2 mg. The safety profile of Eylea 8 mg continued to be favorable in the third year.

Eylea 8 mg has the potential to extend treatment intervals for all DME-patients. Efficacy evaluated by mean change in best-corrected visual acuity (BCVA) was maintained in all Eylea 8 mg patient groups throughout the third year (week 156) compared to the start of the extension study (baseline at week 96).

The safety profile of Eylea 8 mg continued to be favorable in the third year and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals for any of the treatment groups including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups. No cases of occlusive vasculitis were reported. The rate for intraocular inflammation was low throughout the three years (1.4% in patients switched to Eylea 8 mg, and 1.5% in patients randomized at baseline to Eylea 2 mg). These long-term data from PHOTON show the continued durable efficacy and safety of Eylea 8 mg. For patients and ophthalmologists this means reduced burden of disease with comparable efficacy and safety to the current standard of care Eylea 2 mg.

These long-term results are unprecedented and demonstrate that Eylea 8 mg successfully achieves sustained disease control with extended treatment intervals for the vast majority of patients in a setting similar to real-world clinical practice,” said Prof. Diana Do, Byers Eye Institute, Stanford University, USA. “Based on the positive data Eylea 8 mg has the potential to become the new standard of care therapy in diabetic macular edema.”