Aflibercept 8 mg Meets Endpoint in Phase III Study

The QUASAR trial is a global randomized, double-masked, active-controlled phase III study evaluating the efficacy and safety of Eylea 8 mg used with extended dosing intervals in treatment-naïve patients with macular edema secondary to retinal vein occlusion including central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO) and hemiretinal vein occlusion (HRVO). The primary endpoint of this study is to document change in best corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, from the date of randomization through 36 weeks of treatment. The study compares BCVA changes between patients who received Eylea 8 mg every 8 weeks following either 3 or 5 initial monthly doses compared to Eylea 2 mg every 4 weeks. Treatment intervals could be further adjusted based on treatment response continuously evaluated under clinically relevant dose regimen modification (DRM) criteria. Treatment intervals could be shortened by 4 weeks at any dosing visit if patients met DRM criteria. Treatment intervals could be extended based on DRM criteria from week 32 (for the study arms with aflibercept 2 mg and aflibercept 8 mg following 3 initial monthly doses) or week 40 (for the study arm with aflibercept 8 mg following 5 initial monthly doses). Patients will be treated up to week 60 followed by a monitoring period until week 64. The trial has enrolled more than 800 patients from 27 countries.

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.

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.

“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 Prof.  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  Dr.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.”