11.03.20

Aurinia Pharmaceuticals’ Dry Eye Drug Candidate Does Not Meet Primary Endpoint

Source: Aurinia Pharmaceuticals

Aurinia Pharmaceuticals announced topline data from the phase 2/3 AUDREY clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES). The trial did not achieve statistical significance on its primary endpoint of a 10 mm or greater improvement in STT at 4 weeks between active dose groups of VOS compared to vehicle. Aurinia is suspending the development program for VOS based upon these results.

“First and foremost, we would like to thank the patients and investigators who participated in the AUDREY clinical trial. Based upon these initial topline results that we continue to interrogate, we are suspending the DES program at this time,” Peter Greenleaf, President and Chief Executive Officer of Aurinia, said in a company news release. “While surprised by these results, we remain focused on preparing voclosporin for lupus nephritis—which has a different formulation and delivery mechanism compared to VOS. As we approach our lupus nephritis PDUFA action date, the Aurinia team remains committed to our mission of developing novel treatments for people with debilitating and severe autoimmune disease.”

The AUDREY trial was a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 508 subjects were enrolled. The study consisted of four arms with a 1:1:1:1 randomization schedule, in which patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial was the proportion of subjects with a 10 mm or greater improvement in STT at four weeks.

 

Measure

Result (%)

Odds-Ratio
(vs. vehicle)
[95% CI]

p-value
(vs. vehicle)

Primary
Endpoint

Percentage of patients
with a ≥ 10mm
improvement from
baseline in a Schirmer
Tear Test at 4 weeks

VOS 0.05% =10%

2.18 [0.62, 7.62]

p = 0.09

VOS 0.1% = 9%

1.78 [0.49, 6.45]

p = 0.28

VOS 0.2% = 11%

2.48 [0.70, 8.30]

p = 0.13

Vehicle = 5%

N/A

N/A

 

“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,” commented Neil Solomons, MD, Chief Medical Officer.

Secondary outcome measures evaluated in the trial included STT at other time points, Fluorescein Corneal Staining (FCS) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Initial analysis of these secondary outcomes suggests dose-dependent activity and safety were observed across dose groups compared to vehicle. Further analysis of the AUDREY dataset will be conducted over the coming weeks.

 

 

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