Vabysmo approved for retinal vein occlusion macular edema

Indication for Roche Korea’s Vabysmo is expanded

Third indication approved for the drug following neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)

Phase III BALATON and COMINO trials confirm the drug’s non-inferiority in improving visual acuity

Pic of Vabysmo

Roche Korea announced on the 8th that Vabysmo has been approved by the Ministry of Food and Drug Safety (MFDS) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion.

 

With the approval, Vabysmo is now approved for 3 indications in Korea, including as a treatment for ▲neovascular (wet) age-related macular degeneration; ▲visual impairment due to diabetic macular edema; and ▲visual impairment due to macular edema secondary to retinal vein occlusion.

 

Retinal vein occlusion is the second leading cause of blindness due to retinal vascular disease.

 

It primarily affects people over the age of 60 and can cause sudden vision loss.

 

Retinal vein occlusion is divided into two main types: branch retinal vein occlusion, which occurs when one of the four smaller branches of the main central retinal vein becomes blocked, and central retinal vein occlusion, which occurs when the central retinal vein in the eye becomes blocked.

 

The approval of this indication expansion is based on results from the global Phase III BALATON and COMINO clinical trials, which included over 1,200 patients with macular edema secondary to retinal vein occlusion.

 

In BALATON and COMINO trials, Vabysmo met the study's primary endpoint by demonstrating non-inferior visual acuity improvement compared to the control group as measured by best-corrected visual acuity (BCVA) at week 24 in patients with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).

 

Additional long-term data from up to 72 weeks of follow-up showed that more than 57% of patients in the BALATON study and more than 45% of patients in the COMINO study were able to extend the treatment interval to three- or four-month intervals.

 

In the BALATON and COMINO trials, Vabysmo was well tolerated, with a safety profile consistent with previous studies.

 

The most common adverse event was conjunctival hemorrhage (3%), with a comparable safety profile across study arms.

 

“This indication expansion is significant because it allows Vabysmo, the first bispecific antibody treatment for ophthalmic diseases, to contribute to the treatment of a broader spectrum of retinal diseases, in the current situation where it is becoming increasingly important to treat ophthalmic diseases due to the aging population and increase in chronic diseases,” said Ezat Azem, General Manager of Roche Korea.

 

“We will continue to work with key stakeholders, including the government and academia, to support healthier lives for Korean patients with retinal diseases by providing treatments for conditions that can cause blindness.”