Shares of Aurinia Pharmaceuticals (AUPH) dropped in morning trading after the company said its Phase 2 voclosporin ophthalmic solution study failed to meet the primary endpoint. VOS delivered better efficacy on secondary endpoints, however, the company said.
VOS MISSES PRIMARY ENDPOINT: Aurinia Pharmaceuticals on Tuesday announced results from its exploratory Phase 2 head-to-head study evaluating the efficacy, safety and tolerability of voclosporin ophthalmic solution, or VOS, versus Allergan's (AGN) Restasis for the treatment of dry eye syndrome. In the study, VOS was tested against Restasis in a 100-patient 28-day study. Aurinia said both drugs were well-tolerated, but there was no statistical difference between VOS, which is free from the oil that causes eye irritation in patients taking Restasis, and Restasis for the primary endpoint of "drop discomfort," or the stinging or burning in the eye one minute after the first dose is administered.
VOS did, however, demonstrate a statistically significant improvement on secondary endpoints evaluating efficacy, with Aurinia saying VOS showed "rapid and statistically significant improvements over Restasis" at Week 4. VOS beat Restasis on a secondary endpoint that looked at the percentage of subjects who achieved a 10 mm or more improvement on the Schirmer tear test, an objective measure of tear production, and bested the Allergan drug against Fluorescein Corneal Staining, another measure that indicates the integrity of the corneal epithelium, both of which are FDA-accepted efficacy endpoints.
Based on the data, Aurinia Chairman and CEO said the company plans to "aggressively advance VOS for the treatment of DES, which we believe can create considerable value for both patients and our shareholders." He added that "Our pursuit of further development of VOS provides the company with an enhanced pipeline that further capitalizes on the differentiating features of voclosporin and positions us for substantial growth."
WHAT'S NOTABLE: Aurinia's Glickman told Adam Feuerstein of STATNews in a phone interview that beating Restasis in efficacy means VOS could become a blockbuster treatment for dry-eye syndrome, saying "We knocked the efficacy out of the park with VOS... We're really excited but I guess I'll need to explain why to the market." In the trial, Glickman said 43% of patients treated with VOS reported at least 10 millimeters of new tear production compared to 18% of Restasis patients. Allergan secured approval from the FDA for Restasis by showing it could produce 10 millimeters of tears in 15% of patients compared to 5% for a control, Feuerstein noted. "These are objective data, not subjective like tolerability, and they are the data the FDA uses to approve dry eye drugs," Glickman said. "We think there is very little chance that these results are simply random occurrences," added Neil Solomons, Aurinia's chief medical officer. "The data are highly statistical significant."
PRICE ACTION: In morning trading, shares of Aurinia Pharmaceuticals are off earlier lows, but are still down 5.5% to $7.13.
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