Eylea (aflibercept) 8 mg approved in the EU for third retinal indication – Bayer

The European Commission has granted marketing authorization in the European Union (EU) for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of patients with visual impairment due to macular edema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion. RVO is the third indication for Eylea 8 mg.

In the early treatment phase of RVO, treatment is intensive, with intravitreal injections usually administered in monthly intervals (every 4 weeks). In the QUASAR trial, Eylea 8 mg achieved non-inferior functional and anatomic outcomes compared to Eylea 2 mg, with three times fewer patients requiring monthly intervals (every 4 weeks), despite patients in all treatment arms having the option to extend dosing intervals. Patients treated with Eylea 8 mg (after 3 initial monthly injections) not only maintained their visual acuity but required an average of 2-3 fewer injections than those receiving Eylea 2 mg (8.4 vs. 11.7) by week 64. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with dosing intervals of Eylea 2 mg. The study results also showed that Eylea 8 mg was well tolerated, and its safety profile was consistent with results from previous clinical trials.

The QUASAR clinical study met its primary endpoint at week 36, demonstrating that patients receiving Eylea 8 mg every 2 months (after 3 or 5 initial monthly injections) achieved non-inferior visual acuity gains and robust fluid control compared to those receiving Eylea 2 mg (aflibercept 2 mg) monthly. Additional submitted data show that visual acuity was maintained with Eylea 8 mg, and unparalleled durability was demonstrated through the end of the study at week 64. More tha

“Retinal vein occlusion often presents with sudden vision loss and affects older people who are still of working age. Early diagnosis and treatment are essential to help prevent irreversible vision loss; however, the treatment burden of frequent injections can be challenging for patients. In the Phase III clinical trial QUASAR, Eylea 8 mg demonstrated in the key secondary endpoint that it can meaningfully reduce the number of injections while maintaining visual acuity and providing a favorable safety profile,” said Richard Gale, Professor of Ophthalmology Hull York Medical School (HYMS), University of York, and Consultant Medical Ophthalmologist  and one of the trial investigators.

“Eylea 8 mg represents a new treatment option for patients with macular edema due to retinal vein occlusion, addressing the demand for more durable therapies. The recent approval in the European Union expands the range of retinal indications for Eylea 8 mg – now encompassing wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer .In 60% of patients receiving aflibercept 8 mg were able to achieve a last assigned treatment interval of four months and longer, with 40% having a last assigned interval of five months.