Regeneron Pharmaceuticals announced positive three-year data for EYLEA HD (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial, demonstrating sustained visual gains and anatomic improvements in patients with diabetic macular edema (DME). The data, presented at the American Academy of Ophthalmology (AAO) Annual meeting, showed that the majority of patients maintained these benefits with extended dosing intervals.
The PHOTON trial initially randomized patients to either 12- or 16-week dosing intervals of EYLEA HD after three monthly doses. Dosing intervals could be adjusted based on pre-specified criteria. The extension study followed patients for an additional 60 weeks. Key findings from the 156-week data include:
- 88% of EYLEA HD patients (n=152) had a last assigned dosing interval of ≥12 weeks.
- 48% of EYLEA HD patients had a last assigned dosing interval of ≥20 weeks.
- Vision gains and anatomical improvements achieved through year two were sustained through year three.
Slower Fluid Reaccumulation
Patients in the comparator arm initially received EYLEA (aflibercept) Injection 2 mg every 8 weeks for 96 weeks before switching to EYLEA HD every 12 weeks in the extension study. Notably, these patients (n=58) experienced substantially slower fluid reaccumulation after switching to EYLEA HD compared to their previous rate on EYLEA 2 mg. This observation supports the longer duration of action of EYLEA HD.
Safety Profile
The safety profile of EYLEA HD (n=265) remained consistent with previous trials of both EYLEA HD and EYLEA. Ocular treatment emergent adverse events (TEAEs) occurring in ≥4% of patients included cataract, vitreous floaters, and diabetic retinal edema. No cases of occlusive retinal vasculitis were reported. The rate of intraocular inflammation was 1.4% in patients switching from EYLEA to EYLEA HD and 1.5% in patients randomized to EYLEA HD at baseline. Anti-platelet trialists' collaboration-defined arterial thromboembolic TEAEs occurred in 7% of patients in both groups.
Clinical Significance
"Many patients with diabetic eye disease are of working age and often have to juggle a high burden of healthcare appointments and treatments alongside job and family commitments," said Diana V. Do, M.D., Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute, Stanford University, and a trial investigator. "These latest three-year results from the Phase 3 PHOTON trial continue to demonstrate that EYLEA HD can safely provide meaningful and lasting vision and anatomical benefits for people living with diabetic macular edema – with as few as three or four injections per year."
About Diabetic Macular Edema
DME can occur at any stage of diabetic retinopathy (DR) as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME.
Implications for Treatment
The extended dosing intervals and sustained efficacy of EYLEA HD offer a potential reduction in the treatment burden for patients with DME. The slower fluid reaccumulation observed after switching from EYLEA 2 mg to EYLEA HD further supports its longer duration of action, potentially making it a preferred first-line treatment option.
