Bayer’s Eylea gets approval in Japan to treat retinal vein occlusion

RVO is a significant cause of vision impairment and a chronic disease that requires early and ongoing management to obtain the best possible vision.

The company said that the new indication includes macular edema secondary to branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion (CRVO).

Monthly administration of Eylea is preferable until visual acuity becomes stable and the approval is for dosing intervals of one month or longer.

Bayer HealthCare Member of the Executive Committee and Global Development head Dr Joerg Moeller said: "Especially in Japan, the retirement age tends to be rising due to declining birthrates and aging population.

"The loss of even a single line of letters on ETDRS eye chart may impact a patient’s ability to work, and could mean they leave the workforce early.

"Therefore it is of utmost importance to have treatment options available which demonstrated in clinical studies rapid and significant improvements in vision for RVO patients regardless of disease severity."

The Japanese approval is based on positive results from the double-masked, randomized, active-controlled Phase III Vibrant trial in patients with visual impairment due to macular edema secondary to BRVO.

The trial’s primary endpoint was the proportion of subjects who gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24.

The company noted that more than half of the patients who were treated with aflibercept solution for injection gained at least three lines (15 letters) of vision.