Aurinia’s Voclosporin Misses Superior Tolerability Vs. Restasis, But Pushes On In Dry Eye
Aurinia's voclosporin missed the primary endpoint of superior tolerability compared to Restasis, but hit objective secondary efficacy endpoints that that may better position it for approval in dry eye.
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Biotech doesn’t shut the door on returning to ophthalmic formulation of the calcineurin inhibitor in dry eye but puts primary focus on oral voclosporin in lupus nephritis, with an FDA approval decision imminent.
Canada’s Aurinia Pharmaceuticals expects to file a US NDA in the first half of next year on the use of its next-generation calcineurin inhibitor, voclosporin, in lupus nephritis, a condition with no approved therapies.
The London-based group has begun a Phase IIb/III study evaluating TOP1630 which has a safety and tolerability profile that could prove superior to current treatments such as Allergan's market leader Restasis.