Regeneron presents two-year resuts from PULSAR trial of EYLEA HD

Regeneron Pharmaceuticals announced the first presentation of two-year results from the pivotal PULSAR trial investigating EYLEA HD Injection 8 mg with 12- and 16-week dosing regimens, compared to EYLEA Injection, in patients with wet age-related macular degeneration. The results were presented with the 60-week results at the 23rd EURETINA Congress. PULSAR is a double-masked, active-controlled pivotal trial evaluating non-inferiority of EYLEA HD 12-week and 16-week dosing regimens compared to an 8-week dosing regimen for EYLEA. 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 two 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 two-year follow-up were as follows: Among all patients, 88% were on a greater than or equal to12-week dosing interval at the end of two years, with 71% meeting the extension criteria for greater than or equal to16-week dosing intervals. Of patients assigned to greater than or equal to16-week dosing regimen at baseline, 78% were eligible for greater than or equal to16-week dosing at the end of two years, with 53% eligible for greater than or equal to20-dosing week intervals. In PULSAR, the safety of EYLEA HD continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for wAMD. 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.