Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg

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Regeneron Pharmaceuticals has announced results from the phase 3 QUASAR trial and its extension study of the phase 3 PULSAR trial investigating EYLEA HD (aflibercept) Injection 8 mg.

The QUASAR trial a global double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion. In the trial, patients were randomized into 3 groups to receive either: EYLEA HD every 8 weeks following 3 initial monthly doses; EYLEA HD every 8 weeks following 5 initial monthly doses; or EYLEA every 4 weeks. The primary endpoint was mean change in BCVA from randomization through week 36.¹

Results from the QUASAR trial¹ showed that it met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA (aflibercept) Injection 2 mg dosed every 4 weeks. Furthermore, the company noted EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. Of the 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 in the QUASAR trial was similar to EYLEA and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials, according to the company.

Seenu M. Hariprasad, MD, chair of the department of ophthalmology and visual science, The University of Chicago, commented on the QUASAR results in a press release from the company.

“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,” said Hariprasad. “Based on these new data, aflibercept 8 mg may offer the potential to halve the number of injections needed, as compared to standard-of-care aflibercept 2 mg and other anti-VEGF therapies.”

In addition to QUASAR, positive 3-year results were shown from an extension study of the phase 3 PULSAR trial.² According to the company, the longer-term wet age-related macular degeneration (wAMD) 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 Injection 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.

Patients in the PULSAR comparator arm received EYLEA as a fixed 2-month dosing regimen (after 3 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 156.²

W. Lloyd Clark, MD, Palmetto Retinal Center, and assistant clinical professor of ophthalmology at the University of South Carolina School of Medicine commented on the PULSAR results in a press release from the company.

“Patients with wet age-related macular degeneration are older and often need assistance in getting to their doctors’ offices. Reducing their treatment burden can be transformative for their care,” said Clark. “Impressively, the latest three-year EYLEA HD results show a substantial portion of patients were able to sustain visual and anatomic benefits with only two doses a year. This adds yet another notable piece of evidence to an already remarkable body of data supporting EYLEA HD.”

EYLEA HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG.

References:

1. EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting. Published February 8, 2025. Accessed February 10, 2025.https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-positive-phase-3-results

2. Three-Year Results for EYLEA HD® (aflibercept) Injection 8 mg in Patients with Wet Age-related Macular Degeneration Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended Dosing Intervals. Published February 8, 2025. Accessed February 10, 2025. https://investor.regeneron.com/news-releases/news-release-details/three-year-results-eylea-hdr-aflibercept-injection-8-mg-patients