Aurinia Pharmaceuticals and its dry eye drug started 2019 with a mixed bag of data from a head-to-head trial with Allergan’s blockbuster Restasis. Now, it’s unveiling results from a different trial—and they’re definitely not mixed.
The company is abandoning the dry eye program, voclosporin ophthalmic solution (VOS), after the drug failed to beat placebo at helping patients produce more tears in a phase 2/3 study. The study pitted three dose levels of VOS against placebo in 508 patients with dry eye disease, with the goal of treating patients for 12 weeks.
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But after four weeks of treatment, patients on VOS didn’t do much better on the Schirmer tear test, a measure of tear production using strips of paper, than patients on placebo did. Abut 10% of patients taking VOS achieved a 10-mm improvement on that test, compared with 5% of patients on placebo, Aurinia said in a statement Monday.
“While we are understandably disappointed that VOS did not achieve the primary endpoint of the Audrey trial, we uncovered important learnings about this disease state, particularly concerning the patient population with severe dry eye syndrome,” Neil Solomons, M.D., Aurinia’s chief medical officer, said in the statement.
Early last year, Aurinia sought to show VOS was more tolerable than Restasis in its head-to-head study—a goal the drug did not meet—but instead, it came out of that trial with results showing it might beat Restasis on the efficacy side.
Aurinia picked out four-week data on three secondary efficacy endpoints to make its case. Compared to baseline, the worst eyes of patients in the VOS arm produced 8.6 mm more tears after four weeks. The figure for Restasis was 3.3 mm, resulting in the study hitting the Schirmer tear test endpoint.
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Though it’s pulling the plug on the dry eye program, Aurinia is pressing ahead with a different formulation of voclosporin that topped placebo in a phase 3 trial in lupus nephritis. A calcineurin inhibitor, voclosporin is designed to block the expression of IL-2—a protein that promotes inflammation—and stabilize kidney cells that can be damaged in people with lupus nephritis.
The drug picked up a speedy review from the FDA in July, and the agency is expected to decide voclosporin’s fate by Jan. 22.