Roche’s Vabysmo expands indication to retinal vein occlusive macular edema

Roche Korea's Vabysmo (faricimab) has been approved for treating retinal vein occlusive macular edema.

Roche Korea said Wednesday that the Ministry of Food and Drug Safety (MFDS) has approved Vabysmo for treating vision impairment caused by retinal vein occlusive macular edema.

According to Roche Korea, the approval allowed Vabysmo to expand its indication to retinal vein occlusive macular edema in addition to existing indications for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Roche Korea’s macular degeneration treatment Vabysmo

Retinal vein occlusion is the second leading cause of blindness from retinal vascular disease, affecting about 28 million adults worldwide. It primarily affects people over 60 and can cause sudden vision loss.

Retinal vein occlusion is divided into two main types: retinal branch 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. Globally, retinal branch vein occlusion affects 23 million people, and central retinal vein occlusion affects more than 4 million people.

Retinal vein occlusion is known to be accelerated by high expression of angiopoietin-2 (Ang-2) in addition to vascular endothelial growth factor-A (VEGF-A), and the disease progression is generally characterized by blockage of blood vessels, which restricts normal blood flow to the retina, resulting in bleeding, leakage of retinal fluid, and retinal swelling called macular edema.

The MFDS approved the expanded indication for treating vision loss due to retinal vein occlusive macular edema based on results from the BALATON and COMINO global phase 3 clinical trials, which involved more than 1,200 patients with retinal vein occlusive macular edema.

In the BALATON and COMINO studies, Vabysmo met the primary endpoint by demonstrating non-inferior visual acuity improvement compared to control 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).

The study also demonstrated a reduction in retinal fluid as measured by macular central subfield thickness (CST) following treatment with Vabysmo. Retinal fluid dryness is an important clinical indicator, as excessive retinal fluid in the back of the eye is associated with distorted and blurred vision.

Additional long-term data with up to 72 weeks of follow-up showed that more than 57 percent of patients in the BALATON study and more than 45 percent in the COMINO study could extend the interval between treatments to three or four months.

In the BALATON and COMINO studies, Vabysmo was well tolerated and had a safety profile consistent with previous studies. The most common adverse event was conjunctival hemorrhage (3 percent).

Vabysmo is the first bispecific antibody treatment approved for ophthalmic diseases. It has demonstrated a reduction in macular CST from baseline in all three approved indications, non-inferiority to control in the primary endpoint of best-corrected visual acuity (BCVA), and flexible dosing intervals of up to four months based on patient progress.

“This indication expansion is significant as it allows Vabysmo, the first bispecific antibody treatment for ophthalmic diseases, to contribute to the treating a broader spectrum of retinal diseases, which are rapidly increasing in importance due to the aging population and the rise in chronic diseases,” Roche Korea General Manager Ezat Azem said. “Roche Korea will continue to work with key stakeholders, including the government and academia, to support healthier lives for patients with retinal diseases in Korea through treatments for diseases that can cause blindness.”