Aflibercept 8 mg Achieves Primary Endpoint in Phase III, Shows Vision Gains in Retinal Vein Occlusion

Bayer has released promising results from the phase III QUASAR study, which focused on the effectiveness and safety of aflibercept 8 mg in treating macular edema resulting from retinal vein occlusion (RVO). This condition includes variations such as central, branch, and hemiretinal vein occlusion. The study achieved its primary goal by week 36, showing that patients who received aflibercept 8 mg every eight weeks, after initial monthly doses, experienced visual acuity improvements comparable to those receiving the standard Eylea™ 2 mg every four weeks.

Aflibercept 8 mg was generally well tolerated, maintaining a safety profile similar to previous studies. Professor Richard Gale from York Teaching Hospital in the UK highlighted the potential of aflibercept 8 mg to become a new benchmark in treating exudative retinal diseases, such as retinal vein occlusion, which is characterized by high levels of VEGF.

Christian Rommel, part of Bayer’s Pharmaceuticals Division Executive Committee, emphasized that the study's success underscores aflibercept 8 mg’s ability to provide long-lasting disease management. It promises rapid and effective fluid control while allowing for extended treatment intervals, offering similar vision improvements and safety as Eylea 2 mg, but with fewer injections. This could significantly reduce the treatment burden for patients.

During the QUASAR study, an impressive 90% of patients on aflibercept 8 mg were transitioned to eight-week dosing intervals, which they maintained through the 36-week mark. Furthermore, nearly 70% were eligible for 12-week dosing by week 32, potentially easing the frequency of injections. Aflibercept 8 mg also demonstrated a swift and significant decrease in retinal fluid, measured by changes in central subfield thickness (CST), similar to Eylea 2 mg.

The mean number of injections required by week 36 reduced to 6.1 or 6.9 for aflibercept 8 mg patients, depending on whether they began with 3 or 5 initial monthly doses, compared to 8.8 injections for those on Eylea 2 mg every four weeks. Despite the fewer doses, the efficacy and safety outcomes at week 36 were comparable between the two treatment groups.

Aflibercept 8 mg holds approvals in over 50 countries for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) under the Eylea brand. It is notably the first anti-VEGF therapy approved in major markets like the EU and UK for up to five-month treatment intervals in DME and nAMD. It is available both in vials and pre-filled syringes, which facilitates precise dosing.

Jointly developed by Bayer and Regeneron, Eylea 8 mg is marketed outside the United States by Bayer, which shares profits with Regeneron following regulatory endorsements. Regeneron retains exclusive rights over Eylea 2 mg and Eylea HD in the United States.

The QUASAR trial is a comprehensive, global phase III study, involving over 800 patients across 27 countries. It assesses the efficacy and safety of extended dosing intervals of Eylea 8 mg in treatment-naïve patients with macular edema secondary to RVO. The study tracks changes in best corrected visual acuity (BCVA) over a 36-week treatment course and allows for dynamic adjustment of dosing intervals based on patient response.

Retinal vein occlusion is a widespread condition, affecting approximately 28 million adults worldwide and can cause sudden and severe vision loss. It occurs as either central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO), with BRVO being more prevalent. RVO results from oxygen deprivation in the retina, leading to increased production of vascular endothelial growth factor (VEGF), which plays a critical role in the ensuing macular edema.