At Angiogenesis, Regeneron Announces New Data for Eylea HD for RVO and Wet AMD
Regeneron announced the first presentation of positive results from the phase 3 QUASAR trial investigating Eylea HD (aflibercept) 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. Regeneron also announced positive 3-year (156-week) results for Eylea HD patients with wet age-related macular degeneration (AMD) from an extension study of the phase 3 PULSAR trial.
Both sets of data were presented at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2025 annual meeting.
For the RVO indication, the QUASAR trial met its primary endpoint at 36 weeks, with both groups of Eylea HD patients dosed every 8 weeks achieving noninferior visual acuity gains compared to those receiving Eylea (aflibercept) 2 mg dosed every 4 weeks. The Eylea HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. Furthermore, in patients treated with Eylea HD through 36 weeks, 88% of patients were able to sustain an 8-week dosing regimen following 3 initial monthly doses, and 93% of patients maintained an 8-week dosing regimen after completing 5 initial monthly doses.
The safety profile of Eylea HD (n=591) was similar to Eylea (n=301) in QUASAR and remained generally consistent with the known safety profile of Eylea HD in its pivotal trials. Ocular treatment-emergent adverse events (TEAEs) occurring in ≥5% of all Eylea HD patients included increased ocular pressure (5%); there was one case each of endophthalmitis and retinal vasculitis. The rate of intraocular inflammation was 0.5% for Eylea HD and 1.3% for Eylea.
“Retinal vein occlusion is the second most common retinal vascular disease. However, the current treatment paradigm of monthly eye injections can make it challenging for patients to maintain their treatment plan, potentially leading to poor adherence and vision loss,” Seenu M. Hariprasad, MD, Chair of the Department of Ophthalmology and Visual Science, The University of
Regeneron said the new data will support the submission of a supplemental Biologics License Application to the FDA in the first quarter of 2025.
For wet AMD, similar to the 3-year results for the pivotal PHOTON trial in diabetic macular edema (DME), the longer-term wet AMD data demonstrated 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 also achieving substantially longer treatment intervals. Additionally, patients who switched from Eylea (aflibercept) 2 mg to Eylea HD at the beginning of the third year were also able to maintain vision and anatomic improvements through the end of the third year, but with longer dosing intervals and fewer injections, according to Regeneron.
In PULSAR, Eylea HD patients were initially randomized at baseline to either 3- or 4-month dosing intervals (after three initial monthly doses). If pre-specified criteria were met, dosing intervals could be shortened throughout the trial or extended in the second and third years. As previously presented, 88% of all Eylea HD patients maintained ≥3-month dosing intervals at the end of two years. Patients could then participate in an optional extension study for an additional 60 weeks. Of the Eylea HD patients (n=375) who completed the full 3 years of treatment:
- Nearly 60% had a last assigned dosing interval of ≥4 months, with 40% and 24% having a last assigned dosing interval of ≥5 and 6 months, respectively, at the end of three years of treatment.
- Vision gains and anatomical improvements – including robust reductions in retinal thickness – that were achieved through year two were sustained through year three in the extension study.
Patients in the PULSAR comparator arm received Eylea as a fixed 2-month dosing regimen (after three initial monthly doses) for 96 weeks. These patients had the option to enter the extension study at week 96 and were switched to a 3-month dosing interval with Eylea HD. Of these patients who completed the extension study (n=186), vision and anatomic improvements were maintained after switching to Eylea HD, with 79% and 43% having a last assigned dosing interval of ≥3 and ≥4 months, respectively, at week 156.
The safety profile of Eylea HD continued to be similar to Eylea through 3 years and remained generally consistent with the known safety profile of Eylea HD in its pivotal trials. Ocular treatment emergent adverse events (TEAEs) occurring in ≥4% of all patients included cataract, retinal hemorrhage, reduction of visual acuity, vitreous floaters, and increase of intraocular pressure. The rate of intraocular inflammation was 2.4% for the patients that switched from Eylea to Eylea HD, and 1.9% for the Eylea HD patients randomized at baseline.
The 3-year data from the PHOTON trial for Eylea HD in DME were previously presented at the American Academy of Ophthalmology annual meeting in October 2024.