Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion.- Bayer + Regeneron

The QUASAR clinical trial will measure changes in best corrected visual acuity (BCVA) in patients who receive aflibercept 8 mg with extended treatment intervals after initial monthly doses and those who receive Eylea(aflibercept 2 mg) every 4 weeks, until the primary endpoint is assessed at week 36. Treatment intervals can be further extended after the week 36 timepoint. Aflibercept 8 mg has been developed with the aim to extend intervals between injections without compromising vision gains and safety.

"Secondary macular edema is the most common cause of sight loss in retinal vein occlusion. If left untreated, it can cause severe vision loss and can make the simplest tasks, such as driving, walking downstairs, or reading, difficult to complete. We have seen promising positive results of aflibercept 8 mg given at extended treatment intervals in patients with neovascular age-related macular degeneration and diabetic macular edema, so it is important that we also evaluate its potential in retinal vein occlusion," said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development.

"We know that there is a high disease burden with frequent injections in exudative retinal diseases which contributes to poor adherence to treatment and vision loss. Thus, we welcome new research in extended treatment intervals that alleviate the situation for patients and the health care systems while achieving best visual acuity outcomes", said Dr. Varun Chaudhary, Chief of Ophthalmology and Professor of Surgery at Hamilton Regional Eye Institute, McMaster University, Canada.

Eylea (aflibercept 2 mg) is the standard of care treatment for macular edema secondary to RVO and is approved for central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) in over 100 countries worldwide.

The phase III QUASAR clinical trial in macular edema secondary to RVO follows the application for regulatory authorization of aflibercept 8 mg in the EU, Japan, and other markets for the treatment of nAMD and DME. The submissions are based on positive efficacy and safety data from the phase III PULSAR trial in nAMD and the phase II/III PHOTON trial in DME, in which both studies met their primary endpoint of non-inferiority in BCVA at 48 weeks of aflibercept 8 mg with two extended dosing regimens (every 12 and every 16 weeks), compared to Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses.

Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg in the United States.