Japan has approved a new high-dose treatment that could significantly ease the burden on patients at risk of vision loss.

 

The Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization for Eylea 8 mg (aflibercept) to treat visual impairment caused by macular edema following retinal vein occlusion (RVO), a major eye condition that can lead to sudden blindness.

 

The decision marks the third approved use of Eylea 8 mg in Japan and is backed by strong results from the Phase III QUASAR trial.

 

RVO is one of the leading causes of vision loss worldwide, second only to diabetic eye disease among retinal vascular disorders. Without timely diagnosis and treatment, the condition can trigger swelling in the retina and cut off blood supply—causing rapid and sometimes irreversible damage to sight.

 

Experts say the new approval could reshape treatment by reducing how often patients need injections.

 

“In patients with macular edema following retinal vein occlusion, where VEGF is known to be significantly elevated, some patients require long-term outpatient care. In the QUASAR trial, Eylea 8 mg demonstrated similar efficacy and safety compared to Eylea 2 mg while reducing the frequency of injections. 

 

"With the approval of Eylea 8 mg, treatment options will expand, leading to a broader range of treatments that can reduce the burden on patients more than ever before,” said Professor Motohiro Kamei, Department of Ophthalmology, Aichi Medical University, Aichi, Japan, and one of the trial investigators.

 

The data underline that promise. Patients receiving the higher-dose treatment maintained their vision while needing fewer injections—an average of 3 fewer over the study period compared to the standard 2 mg dose. More than 60% of patients were able to stretch treatment intervals to four months or longer, with 40% reaching five months between doses.

 

Crucially, the drug delivered comparable control of retinal swelling—an important marker of disease stability—even with these extended intervals.

 

Industry leaders say the approval gives patients access to a more durable therapy without compromising safety.

 

“In Japan, retinal vein occlusion ranks as the second most common retinal disease, following age-related macular degeneration. With the introduction of Eylea 8 mg, patients now have access to a more durable treatment option that maintains both efficacy and safety for macular edema associated with retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

 

Eylea 8 mg has already secured approval for the same condition in the European Union and is now cleared in more than 60 markets for other major eye diseases, including wet age-related macular degeneration and diabetic macular edema.

 

Globally, retinal vein occlusion affects an estimated 28 million adults. The condition occurs when veins in the retina become blocked, leading to fluid leakage, swelling in the macula, and impaired central vision. In severe cases, it can result in sudden and permanent sight loss.