TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) announced that The Lancet has published one-year results from the PULSAR and PHOTON trials, indicating that EYLEA HD (aflibercept) Injection 8 mg with 12- or 16-week dosing regimens is non-inferior to the standard 8-week dosing of EYLEA (aflibercept) Injection 2 mg.
These findings suggest that EYLEA HD could offer patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) a reduced treatment burden without compromising safety or efficacy.
The published results from these pivotal trials reveal that EYLEA HD achieved comparable vision gains and controlled retinal fluid as effectively as the standard EYLEA treatment over the course of the first year. The trials involved a total of 1,667 patients, with 1,009 in the PULSAR trial for wAMD and 658 in the PHOTON trial for DME.
After three initial monthly doses, patients on EYLEA HD were able to maintain extended dosing intervals—79% and 77% for wAMD and 91% and 89% for DME patients at the 12- and 16-week intervals, respectively.
The safety profile of EYLEA HD was consistent with the known profile of EYLEA, with the most common adverse reactions being cataract, conjunctival hemorrhage, and increased intraocular pressure, among others.
EYLEA HD received approval from the U.S. Food and Drug Administration in August 2023 for the treatment of wAMD, DME, and diabetic retinopathy (DR), based on the one-year data from these trials. It is also approved in the European Union, Japan, and other countries, with additional regulatory submissions underway.
Regeneron and Bayer AG (ETR:BAYGN) jointly developed EYLEA HD. Regeneron holds exclusive rights in the U.S., while Bayer (OTC:BAYRY) has exclusive marketing rights outside the U.S., with profits from sales shared equally.
This news is based on a press release statement, and the one-year results from the PULSAR and PHOTON trials are a significant milestone in the management of retinal diseases, potentially offering patients fewer injections with maintained efficacy.
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