The U.S. approval and launch of Novartis’s Beovu (brolucizumab-dbll) in early October made the drug the fourth anti-vascular endothelial growth factor (VEGF) therapy to reach the market for the treatment of wet age-related macular degeneration (AMD), following Macugen (Bausch + Lomb/Pfizer), Lucentis (Roche/Novartis), and market-leading Eylea (Regeneron/Bayer/Santen). While each of these products have represented a treatment advance, this historically small market is expected to become increasingly fragmented over the next ten years. The pressure is on Novartis to meaningfully differentiate Beovu in the minds of ophthalmologists before other branded (and biosimilar) anti-VEGF therapies enter the marketplace.
Beovu and Eylea go head-to-head in TALON study while competition heats up
A major unmet need in wet AMD treatment is less frequent dosing. Ophthalmologists typically use a treat-and-extend protocol when prescribing anti-VEGFs, extending the time between injections if a patient’s disease activity is controlled. Although Beovu was approved by the FDA for dosing once every 8-12 weeks after the first three months of treatment, giving it an edge over Eylea whose U.S. label states that dosing intervals can be extended to 12 weeks after the first year of effective bimonthly treatment, it is unclear how differentiated Beovu’s dosing frequency will be from Eylea in actual clinical practice. Ophthalmologists interviewed by DRG prior to Beovu’s approval stated that the product’s superiority for retinal drying over Eylea was more impressive than its dosing advantage. With the large global Phase III TALON study initiated in September 2019, Novartis intends to address the pressing question of Beovu’s treatment durability compared with Eylea in wet AMD patients when both therapies are administered following an identical treat-to-control protocol. The first data readout from the TALON study is expected in 2021. Meanwhile, competition is heating up as Regeneron and Bayer have listed a Phase II clinical trial investigating the duration of effect of high dose aflibercept also expected to be completed in 2021, and Allergan’s abicipar pegol (also dosed once every 12 weeks) is expected to launch in mid-2020.
Emerging therapies will offer many choices for patients, with Beovu leading the pack
Since Lucentis, Eylea, and off-label compounded Avastin all offer safe and effective treatment for wet AMD, we expect incremental advantages to be increasingly important in the wet AMD competitive landscape going forward. On the horizon, there are three late-phase emerging anti-VEGF therapies in development for wet AMD that aim to offer improved intravitreal dosing convenience for patients as well as the first long-acting port delivery system for a biologic therapy that could extend treatment intervals to six months. Novartis had taken an aggressive pre-launch approach for Beovu, including securing a priority review from the FDA, to maximize the chances of strong market uptake ahead of emerging competitors.
For an up-to-date in-depth analysis of competitive dynamics in the AMD market, as well as a ten-year annualized forecast for Beovu and other emerging products, please check out our latest insights in Dry and Wet Age-Related Macular Degeneration | Disease Landscape & Forecast.
Key questions answered in this report include:
- Now that Beovu has begun launching globally, what are Novartis’s lifecycle management plans for the product?
- To what extent are the new and emerging VEGF inhibitors as well as an emerging VEGF/Ang-2 inhibitor expected to capitalize on the unmet need for less frequent dosing in wet AMD? How will these emerging therapies be differentiated from Beovu, Eylea, Lucentis, and Avastin?
- What will be the likely market impact of biosimilar versions of Lucentis and Eylea on current and emerging VEGF inhibitors?
We will also be offering insights specific to tracking Beovu’s U.S. market launch which include assessing product awareness, perceptions, and usage among ophthalmologists at 3, 6, and 12 months post-launch. To be one of the first to access Wet Age-Related Macular Degeneration|Spotlight on Emerging Therapies: Beovu when it is released in early 2020, please connect with us today.