Roche Clocks Clinical Win as it Eyes Additional Vabysmo Indication

Pharma giant Roche announced positive topline Phase 3 results from two clinical trials evaluating the safety and efficacy of its eye injection medicine, Vabysmo, to treat macular edema following two kinds of retinal vein occlusion (RVO). The FDA approved the drug to treat neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema earlier this year as the first and only bispecific antibody for the eye. 

Two Clinical Trials Bolstering Vabysmo’s Potential

After snagging approvals earlier this year by holding up to Regeneron and Bayer’s blockbuster eye med, Eylea, Roche is on the hunt to expand Vabysmo’s market by branching into other indications. The drug underwent two sets of clinical trials, the BALATON and COMINO Phase 3 studies, to study Vabysmo’s effect on macular edema caused by branch and central retinal vein occlusion (BRVO and CRVO).

RVO is a common cause of vision loss, most often experienced in patients 60 or older. Affecting about 23 million people each year, BRVO is caused by a blockage of one of the four smaller branches of the main central retinal vein. CRVO is less common but still affects more than four million people worldwide and is caused by a central retinal vein blockage. 

As the first and only bispecific antibody for eye diseases, Vabrysmo targets two disease pathways linked to retinal conditions. Roche designed the drug to neutralize angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A can destabilize blood vessels, leading to new leaky blood vessels, which can cause inflammation and accelerate vision loss. By targeting the two pathways, Vabysmo can stabilize retinal blood vessels, reducing the risk of vision loss or impairment. 

Both studies again compared Vabysmo to Eylea, where Roche’s drug demonstrated non-inferior visual acuity gains compared to Regeneron’s medication, meeting both studies’ primary endpoints. The BALATON study included 553 participants with BRVO, and the COMINO study enrolled 729 people with CRVO. 

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, said, “These encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss. Today’s results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions.”

Roche will unveil more detailed results at an upcoming medical meeting before submitting the data to regulatory agencies worldwide. Over 40 countries approved Vabysmo for at least one indication. 

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Vabysmo’s Quest to Overtake Eylea

It is still early days for Vabrysmo, which received its first set of approvals for wet AMD and diabetic macular edema in January this year. Still, it is performing well, generating 109 million Swiss francs ($112 million) in its first six months on the market. 

Vabysmo’s battle to beat Eylea is all uphill, largely due to Eylea’s impeccable and long track record. The FDA first approved Eylea in 2011 to treat wet AMD, followed by an approval to treat macular edema following CRVO in 2012. Last year, Eylea raked in $5.7 billion, a 17% increase over the previous year.

Even though it is a tall order, Roche is hard at work proving Vabysmo’s worth in the eye disease market. The most recent clinical trial data is a step in the right direction to get Vabysmo approved for another indication. With positive results from two sets of clinical trials, Roche is on the path to submitting data to regulatory agencies worldwide to get Vabysmo approved to treat macular edema following BRVO and CRVO. 

Author

Reed Slater