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.”

In QUASAR the vast majority of aflibercept 8 mg patients (approximately 90%) were extended to every 8-week dosing and maintained their interval through 36 weeks. Almost 70% were assigned every 12-week dosing at the week 32 visit, potentially further alleviating the burden associated with frequent injections. Aflibercept 8 mg also demonstrated rapid and robust reduction of fluid in the retina similar to Eylea 2 mg, as measured by changes in central subfield thickness (CST) from baseline through week 36. Reduction of fluid in the retina and reducing CST are associated with disease control. The mean number of injections through week 36 was reduced to 6.1 or 6.9 injections with aflibercept 8 mg dosed every 8 weeks (following 3 or 5 initial monthly doses) versus 8.8 injections with Eylea 2 mg dosed every 4 weeks. Despite fewer injections, aflibercept 8 mg every 8 weeks achieved similar efficacy and safety to Eylea 2 mg every 4 weeks at week 36.

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 Eylea 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 (aflibercept 8 mg; in the United States and Canada: Eylea HD) 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.