Allergan has positive phase III results for a wet age-related macular degeneration (AMD) drug that seems to be at least as good as a big-selling rival from Roche/Novartis – and can be dosed less often.
Allergan and partner Molecular Partners say a pair of two studies of abicipar show that the drug is non-inferior to monthly dosing with Roche and Novartis’ blockbuster Lucentis (ranibizumab) when given every eight or 12 weeks, meeting its primary objective.
The new drug could halve the number of injections into the eye that are needed by wet AMD patients from 13 with Lucentis to six or eight, according to the duo, although the two trials – called CEDAR and SEQUOIA – didn’t go off entirely without a hitch. Abicipar was associated with higher levels of inflammation within the eye as Lucentis, and Allergan says it is “working on optimising” the manufacturing process and formulation of the drug to try to minimise that side effect.
CEDAR and SEQUOIA both compared the two drugs on their ability to prevent the progressive loss of vision that characterises wet AMD over the course of a year’s treatment, using a threshold of a 15 letter or less deterioration on eye standard charts.
In CEDAR, 91.7% of patients on the eight-week abicipar group were within that category, compared to 91.2% of the 12-week dosing group and 95.5% of those on Lucentis. SEQUOIA followed the same pattern with proportions of 94.8%, 91.3% and 96% respectively. Both studies will continue for another year.
Lucentis – sold by Roche in the US and Novartis in Europe and other markets – and Regeneron’s Eylea (aflibercept) currently dominate the wet AMD market. Last year, Roche recorded US sales of its drug of around $1.4bn while Novartis chalked up $1.9bn, collectively still well behind Eylea’s market-leading tally of almost $6bn.
The current therapies and particularly Eylea will take some dislodging, and while Allergan and Molecular Partners hope that reducing the injection frequency will be a big draw for patients and physicians, Regeneron has also been developing a 12-week dosing schedule for its drug that is on course for an FDA verdict next month.
Allergan says it is targeting a regulatory filing for abicipar in the US in the first half of 2019, and will be requesting a meeting with the FDA to discuss the regulatory requirements. Share in the company dipped on the announcement – perhaps because investors are looking for a stronger case for the drug against Regeneron’s brand.
Nevertheless, Allergan’s R&D chief David Nicholson (pictured) said the company is pleased with the outcome of the trials.
“We believe the SEQUOIA and CEDAR studies demonstrated what we set out to achieve, strong efficacy and duration of effect which shows the potential of abicipar as a treatment for AMD patients.”