Aurinia forced to see past dry eye to lupus

Aurinia Pharmaceuticals’ efforts in dry eye syndrome have remained confusing right to the end. Yesterday the group said it would be suspending development of voclosporin ophthalmic solution here after a late-stage study missed its primary endpoint, a 10mm or greater improvement in the Schirmer tear test (STT). The flop in the phase II/III Audrey trial is perhaps surprising following what looked like strong efficacy in a previous 2019 phase II trial, where voclosporin showed superiority over Allergan’s Restasis on STT scores. However, that previous trial did not meet its primary endpoint, improved tolerability versus Restasis. On an investor call management blamed the failure of Audrey on “a very dry eye” patient population. Shares in Aurinia opened down 9% this morning on the news – another surprise, given that few analysts had assigned value to voclosporin in dry eye, with much of the drug’s $1.1bn forecast tied to lupus nephritis (LN), according to EvaluatePharma. There is arguably a silver lining to the cloud of failure in that Aurinia’s management can now switch its focus to efforts in LN, where voclosporin faces a PDUFA date of January 22.

Audrey trial results
Voclosporin ophthalmic solution dose  Percentage of patients with improvement of at least 10mm from baseline on STT at 4wk P value
0.05% 10% 0.09
0.1% 9% 0.28
0.2% 11% 0.13
VOS=voclosporin ophthalmic solution. STT=Schirmer tear test. Source: Company press release. 

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