Bayer Launches Phase III QUASAR Head-to-Head Study of Aflibercept 8 mg in Retinal Vein Occlusion

On May 10, Bayer announced the initiation of the Phase III QUASAR study, aiming to evaluate the efficacy and safety of aflibercept 8mg administered with extended treatment intervals compared to the standard treatment regimen of Eylea (aflibercept 2mg) in macular edema secondary to retinal vein occlusion (RVO).

QUASAR Trial is a global, randomized, double-blind, positive-controlled Phase III study, expected to enroll approximately 800 patients, with the primary endpoint being the change in Best Corrected Visual Acuity (BCVA) at Week 36. The study will separately record the BCVA changes in patients receiving aflibercept 8mg with extended treatment intervals and those treated with Eylea every four weeks until the primary endpoint is assessed at Week 36. After Week 36, the treatment intervals may be further adjusted based on individual circumstances and will continue until Week 60, followed by a monitoring period until Week 64.

Aflibercept was co-developed by Bayer and Regeneron. Regeneron retains exclusive rights to aflibercept in the United States, while Bayer has obtained exclusive marketing rights outside the United States.

Currently, Aflibercept 8mg is in the marketing application stage. In February 2023, Bayer announced the submission of a marketing application to the European Medicines Agency (EMA) for the Aflibercept 8mg formulation, intended for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). In the same month, Regeneron announced that the marketing application for Aflibercept 8mg received priority review from the FDA, with a PDUFA date of June 27, 2023.

These marketing applications are based on the positive data from the Phase III PULSAR study of aflibercept 8mg for nAMD and the Phase II/III PHOTON study for DME. At week 48, both studies met their primary endpoint of non-inferiority, with aflibercept 8mg dosed every 12 or 16 weeks showing non-inferiority in BCVA scores compared to aflibercept 2mg dosed every 8 weeks, and the vast majority of patients being able to maintain a dosing interval of every 12 or 16 weeks. The success of these two pivotal studies means that the aflibercept 8mg formulation can extend the treatment interval from every two months to every four months.

"Secondary macular edema is the most common cause of vision loss in retinal vein occlusion. If left untreated, it can lead to severe vision loss," said Dr. Christian Rommel, member of the executive committee and head of R&D at Bayer's pharmaceuticals division. "We have seen encouraging positive results with extended treatment intervals of aflibercept 8mg in patients with neovascular age-related macular degeneration and diabetic macular edema, so we must evaluate its potential in retinal vein occlusion."

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