Roche is hyping up the early financials coming in for its eye disease therapy Vabysmo as the Swiss major looks to take on the might of Regeneron and Bayer’s major blockbuster, Eylea.
Despite only being approved at the start of the year and the launch coming several months later, Roche saw Q2 sales hit a healthy CHF 109 million ($112 million), which the pharma said in an accompanying investor presentation “showed an excellent uptake.”
Roche said that more than 70,000 vials have been distributed in the first five months of its U.S. launch and that it was seeing “strong customer uptake, with switching coming primarily from aflibercept [Eylea].”
The drug already has a CHF 500 million annual run rate, which is based on June's sales figures, said Bill Anderson, CEO of Roche’s pharma unit in a call with analysts.
Back in January the drug nabbed a green light for wet age-related macular degeneration (AMD) as well as a label to treat diabetic macular edema (DME), which makes Vabysmo the lone injectable therapy approved simultaneously in the U.S. for both conditions.
The pharma said it also reckons the global retina market in total is set to grow to $15 billion by 2025, led by AMD. Roche expects nearly $9 billion to come from the AMD market alone. The company also believes there will be “rapid market transition to next-generation products” such as Vabysmo. The Roche med is a bispecific antibody and is the first and only FDA-approved treatment designed to block both VEGF and Ang-2., while other approved therapies block VEFG.
“We’re super excited by the momentum here on this [Vabysmo] launch,” said Anderson.
He said that since those 70,000 vials have been used in the real world, Roche hasn’t “seen any unusual safety signals,” which bodes well for the drug because doctors are closely watching to make sure there are no surprises when it comes to clinical use.
In trials Roche has seen some patients have eye infections and increased pressure in the eye when using the drug, and there have also been rare reports of patients having had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events).
While Vabysmo is the first bispecific antibody therapy for the eye, this is also not Roche’s first rodeo in ophthalmology given its development, launch and marketing work for Lucentis, which is a blockbuster for the company.
Lucentis made $1.46 billion in 2021 and is FDA-approved for a host of conditions including neovascular wet AMD and DME, macular edema following retinal vein occlusion, diabetic retinopathy and myopic choroidal neovascularisation.
Back in October, Roche also nabbed an FDA nod for its surgical implant system Susvimo. With Lucentis, Susvimo and Vabysmo, Roche has a major ophthalmology franchise, but there are barriers ahead.
Lucentis sales were in fact down 4% in 2021 compared to 2020, and cheaper copycat drugs are threatening its future sales stream. Lucentis is also nowhere near the $9 billion Eylea is bringing in every year for its licences in wet AMD, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
But just last week, Roche was buoyed by new data out for Vabysmo. The results showed the Roche drug could be just as effective and doesn't have to be dosed as often as Eylea, which is given to patients at one- to two-month intervals. Currently, Vabysmo is recommended to be given via intravitreal injection every 4 weeks for at least 4 doses.
In the Tenaya and Lucerne trials, after two years on Vabysmo, more than 60% of patients could be treated every four months—a significant improvement on the one-year data which showed 45% of patients could be extended to four-month intervals. Nearly 80% of patients could go at least three months between injections, the latest data showed.
Over the two-year span, patients on Vabysmo needed a median of 10 injections, while patients on Eylea required a median of 15 shots. That works better for patients, who would like to have as few injections in the eye as possible, and may well help Vabysmo have an edge in the market.