Novartis expects to learn in October if it has obtained FDA approval of a biologics license to market brolucizumab for the treatment of neovascular age-related macular degeneration (AMD). Approval could begin a shakeup in a market where the competitive options have not changed since 2011, according to a Market Scope report.
Novartis has vowed to launch brolucizumab in the US market before the end of the year if the approval comes through in October.
Brolucizumab would be the newest entry in the class of vascular endothelial growth factor inhibitors, also called anti-VEGFs, administered by intravitreal injection to treat neovascular (wet) AMD, but not for long. Allergan aims to introduce abicipar pegol, another new anti-VEGF, to the US and European markets in late 2020.
Anti-VEGFs are widely used to treat wet AMD, diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and retinal vein occlusion (RVO). They are sometimes used to treat severe nonproliferative diabetic retinopathy without DME.
Market Scope’s newly published “2019 Retinal Pharmaceuticals Market Report” estimates the anti-VEGF market in the United States is a $6.4 billion market in 2019, an 11 percent increase over 2018. The US market accounts for 55.1 percent of the worldwide market for anti-VEGFs in ophthalmology.
Three anti-VEGFs already are in use in the US to treat retinal disease: bevacizumab, ranibizumab, and aflibercept. Bevacizumab is the most widely used, because it is the least expensive, but aflibercept reaps the most revenue, $4.1 billion in 2018. Aflibercept, marketed as Eylea by Regeneron, earns almost 70 percent of anti-VEGF revenues in the US.
Bevacizumab, marketed under the brand name Avastin by Genentech/Roche, was developed as a cancer drug and is used off-label in ophthalmology. Ranibizumab, marketed in the US as Lucentis by Genentech/Roche, is a fragment of bevacizumab developed for ocular use.
Anti-VEGFs have proven very successful in treating the signs and symptoms of wet AMD; however, many patients do not receive optimum treatment because of the need for frequent clinic visits and injections and the cost of treatments. Finding ways to maintain treatment efficacy while reducing the number and cost of clinic visits has been an ongoing challenge in the industry.
Novartis has high hopes for brolucizumab. The company reportedly looks for annual global sales to reach $1.5 billion by 2024. Market Scope forecasts that global anti-VEGF sales for retinal disease that year, including sales of biosimilars, will approach $17 billion.
Market Scope’s “2019 Retinal Pharmaceuticals Market Report: A Global Analysis for 2018 to 2024” was published in September.