Regeneron announces three-year data for EYLEA HD Injection 8 mg study

Regeneron (REGN) announced three-year data for EYLEA HD Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema, or DME. At three years, the longer-term data showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year, while achieving substantially longer treatment intervals than have been previously demonstrated. Notably, patients switched to EYLEA HD experienced substantially slower fluid reaccumulation following their first EYLEA HD dose. The achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation – supports the longer duration of action of EYLEA HD. The results were presented today in a late-breaking session at the American Academy of Ophthalmology, or AAO, Annual meeting. In PHOTON, EYLEA HD patients were initially randomized at baseline to either 12- or 16-week dosing intervals. If pre-specified criteria were met, dosing intervals could be shortened throughout the trial or extended in the second and third year. As previously presented, 89% of all EYLEA HD patients completing week 96 maintained 12-week dosing intervals. Patients could then participate in an optional extension study for an additional 60 weeks. Of the EYLEA HD patients who completed the full 156 weeks of treatment: 88% were assigned a dosing interval of 12 weeks, and 48% were assigned a dosing interval of 20 weeks, at the end of three years of treatment. Vision gains and anatomical improvements achieved through year two in PHOTON were sustained through year three in the extension study. Patients in the PHOTON comparator arm received EYLEA Injection 2 mg as a fixed 8-week dosing regimen for 96 weeks. These patients were then able to enter the extension study at week 96 and switch to a 12-week dosing interval with EYLEA HD. Of these patients who completed the extension study, 83% had a last assigned dosing interval of 12 weeks at the end of the study, while mean visual and anatomic improvements achieved with EYLEA in the first 96 weeks were sustained following the switch to longer dosing intervals with EYLEA HD. Notably, patients synchronously switched to the EYLEA HD dose experienced substantially slower fluid reaccumulation following their first dose – as compared to their previous rate of fluid reaccumulation while on EYLEA treatment. The consistent achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation observed following switch to EYLEA HD – support the longer duration of action of EYLEA HD versus EYLEA. In the extension study, the safety profile of EYLEA HD continued to be similar to EYLEA through three years and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment emergent adverse events occurring in 4% of all patients included cataract, vitreous floaters, and diabetic retinal edema. There were no cases of occlusive retinal vasculitis. The rate of intraocular inflammation was 1.4% for the patients that switched from EYLEA to EYLEA HD, and 1.5% for the EYLEA HD patients randomized at baseline. Anti-platelet trialists’ collaboration-defined arterial thromboembolic TEAEs occurred in 7% of patients in both groups.