Bayer announced today positive topline results from the global phase III QUASAR study evaluating the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion (RVO), including central, branch and hemiretinal vein occlusion. The study met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every 8 weeks (after initial monthly doses) achieved non-inferior visual acuity gains compared to those receiving the current standard therapy Eylea™ 2 mg (aflibercept 2 mg) every 4 weeks.

Aflibercept 8 mg was well tolerated, and its safety profile was consistent with previous clinical trials.

“These encouraging data demonstrate that aflibercept 8 mg has the potential to become a new standard of care in the treatment of exudative retinal diseases including patients living with retinal vein occlusion, which is known to have a high VEGF load,” said Professor Richard Gale, Clinical Director at York Teaching Hospital, UK.

“The successful outcome of the study establishes the capacity of aflibercept 8 mg to provide sustained disease control,” said Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “Aflibercept 8 mg delivers rapid and resilient fluid control and allows long treatment intervals with vision gains and tolerability comparable to Eylea 2 mg. For the patients this means less frequent injections at comparable efficacy and safety.”

Detailed results will be submitted to regulatory authorities worldwide and presented at upcoming medical meetings.

Aflibercept 8 mg is approved in more than 50 countries for the indications neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) under the brand name EyleaTM 8 mg. Eylea 8 mg became the first anti-VEGF treatment approved in major markets such as the EU and UK for treatment intervals of up to 5 months in DME and nAMD. In the EU and further countries. Eylea 8 mg is available in a vial and a pre-filled syringe that simplifies the accurate delivery of the recommended dose.

Eylea 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg following any regulatory approvals.