Regeneron Pharmaceuticals Presents Positive Two-Year Results from PULSAR Trial for EYLEA® HD in Wet Age-Related Macular Degeneration
Regeneron Pharmaceuticals, a leading biotechnology company, has announced the first presentation of positive two-year results from the pivotal PULSAR trial for EYLEA® HD (aflibercept) Injection 8 mg. The trial investigated the efficacy and safety of EYLEA HD with 12- and 16-week dosing regimens compared to EYLEA in patients with wet age-related macular degeneration (wAMD). The results, presented at the 23rd EURETINA Congress, demonstrate that EYLEA HD can provide sustained and consistent visual and anatomic benefits with extended dosing intervals, reducing the treatment burden for patients with exudative retinal diseases.
The PULSAR trial, which involved 1,009 patients, evaluated the 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, and dosing intervals could be adjusted based on disease progression. The trial met its primary endpoint, with EYLEA HD patients achieving clinically equivalent vision gains to EYLEA at 48 weeks. The two-year data showed that EYLEA HD patients maintained durable vision gains at extended dosing intervals, with the mean number of injections administered being 9.7 for the 12-week group, 8.2 for the 16-week group, and 12.8 for the EYLEA group.
The safety profile of EYLEA HD remained consistent with EYLEA throughout the two-year trial, with no cases of occlusive retinal vasculitis or endophthalmitis in the EYLEA HD groups. The rate of intraocular inflammation was low, and treatment-emergent adverse events were comparable between the two groups.
Dr. Charles C. Wykoff, Director of Research at Retina Consultants of Texas and a trial investigator, emphasized the potential of EYLEA HD as a new standard of care, highlighting its ability to provide sustained benefits while reducing the treatment burden for patients with exudative retinal diseases.
Regeneron Pharmaceuticals, in collaboration with Bayer AG, is developing EYLEA HD. In the United States, Regeneron maintains exclusive rights to EYLEA and EYLEA HD. The companies share profits from sales of EYLEA and EYLEA HD outside the U.S. following regulatory approvals.
The positive two-year results from the PULSAR trial reinforce the potential of EYLEA HD as an effective treatment option for patients with wet age-related macular degeneration. The sustained visual and anatomic benefits, along with the reduced treatment frequency, offer hope for improved quality of life for individuals affected by this condition.