Two-Year Results of Eylea HD (Aflibercept 8 mg) from PULSAR Trial for Wet AMD Presented at Euretina

Regeneron announced the first presentation of positive 2-year (96 weeks) results from the PULSAR trial investigating Eylea HD (aflibercept) injection 8 mg with 12- and 16-week dosing regimens, compared to Eylea (aflibercept) injection, in patients with wet age-related macular degeneration (AMD). The results were presented with the 60-week results at the 23rd Euretina Congress.

“Eylea HD was approved in the US based in part on strong 1-year efficacy and safety outcomes from PULSAR in wet age-related macular degeneration,” Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas and a trial investigator, said in a company news release. “These 2-year outcomes from PULSAR show that Eylea HD can deliver sustained and consistent visual and anatomic benefits with extended dosing intervals in the longer-term–helping to reduce the treatment burden for patients with exudative retinal diseases and reinforcing the potential of Eylea HD as a new standard of care.”

PULSAR (N=1,009) is a double-masked, active-controlled pivotal trial evaluating noninferiority of Eylea HD 12-week (n=335) and 16-week (n=338) dosing regimens, compared to an 8-week dosing regimen for Eylea (n=336). All patients received three initial monthly doses. Patients receiving Eylea HD could have their dosing intervals shortened to an every 8-week interval if protocol-defined criteria for disease progression were observed. Patients were only able to extend their dosing intervals in the second year by 4-week increments up to 24-weeks, if pre-specified criteria were met.

The PULSAR trial met its primary endpoint, with Eylea HD patients achieving clinically equivalent vision gains to Eylea at 48 weeks. As previously announced, Eylea HD demonstrated durable vision gains at extended dosing intervals at the end of 2 years, with the mean number of injections administered being 9.7 for the 12-week Eylea HD group; 8.2 for the 16-week Eylea HD group; and 12.8 for the Eylea group. As presented at Euretina, efficacy results for Eylea HD patients who completed the 2-year follow-up were as follows:

• Among all patients, 88% were on a ≥12-week dosing interval at the end of 2 years, with 71% meeting the extension criteria for ≥16-week dosing intervals
• Of patients assigned to ≥16-week dosing regimen at baseline, 78% were eligible for ≥16-week dosing at the end of 2 years, with 53% eligible for ≥20-dosing week intervals

In PULSAR, the safety of Eylea HD continued to be similar to Eylea through 2 years and remained consistent with the known safety profile of Eylea from previous clinical trials for wet AMD. There were no cases of occlusive retinal vasculitis or endophthalmitis in the Eylea HD groups. The rate of intraocular inflammation was 1.3% for the aflibercept 8 mg group and 2.1% for the Eylea group. Anti-platelet trialists' collaboration-defined arterial thromboembolic treatment-emergent adverse events occurred in 1.8% of patients treated with aflibercept 8 mg, and 3.3% of patients treated with Eylea.

The full Euretina presentation is available on the Regeneron website. The 2-year data from the PHOTON trial for aflibercept 8 mg in diabetic macular edema (DME) and diabetic retinopathy (DR) were previously presented at the American Society of Retina Specialists annual meeting in July 2023.

EYLEA HD is being jointly developed by Regeneron and Bayer AG. In the US, Regeneron maintains exclusive rights to Eylea and Eylea HD. Bayer has licensed the exclusive marketing rights outside of the US, where the companies share equally the profits from sales of Eylea and Eylea HD following any regulatory approvals.

About the Eylea HD Clinical Trial Program

PULSAR in wAMD and PHOTON in DME/DR are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: Eylea HD every 12 weeks, Eylea HD every 16 weeks, or Eylea every 8 weeks. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.

Patients treated with Eylea HD in both trials had 3 initial monthly doses, and patients treated with Eylea received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the Eylea HD groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study. Patients in all Eylea groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.