Allergan’s abicipar looks safer, but perhaps not safe enough

Allergan has brought down rates of ocular inflammation with a new formulation of abicipar. But the wet age-related macular degeneration (AMD) project will still have a hard time if it reaches the market. The Maple trial found that 9% and 1.65% of patients experienced ocular inflammation and serious ocular inflammation respectively, lower than in the phase III Sequoia and Cedar trials of the original formulation. Still, this rate of inflammation is well above that seen with Regeneron's marketed AMD drug, Eylea, and Novartis’s brolucizumab, which could be approved by the end of this year. Allergan claims that abicipar could become the first anti-VEGF with a “true” 12-week dosing schedule; 12-week dosing of Eylea is also approved, but only after a year of more frequent treatment, while Novartis has tested eight and 12-week doses of brolucizumab. However, in Maple abicipar was given every eight weeks, raising doubts about abicipar’s dosing schedule. And competition will only become fiercer when biosimilar versions of Lucentis and Eylea hit the market, expected in 2021 and 2024 respectively. Sellside consensus puts 2024 abicipar sales at only $178m, representing yet another flop for Allergan, which is coming under increasing pressure to make big changes.

Ocular inflammation rates with the anti-VEGFs
Abicipar old formulation* ~15%
Abicipar new formulation** 8.9%
Lucentis* 0-0.6%
Eylea*** 0.01%
Brolucizumab*** 3-5%
*In Sequoia/Cedar trials; **in Maple trial; ***per Stifel note, April 2, 2019.

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