re: AUPH - Aurinia Pharmaceuticals

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Aurinia Announces Voclosporin Ophthalmic Solution Demonstrates Statistically Superior Efficacy Versus Restasis® in a Phase 2 Head-to-Head Study for the Treatment of Dry Eye Syndrome

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VOS showed statistical superiority to Restasis® on FDA-accepted objective signs of DES
42.9% of VOS subjects vs 18.4% of Restasis® subjects (p=.0055) demonstrated = 10mm improvement in STT at Week 4

Primary endpoint of drop discomfort at 1-minute on Day 1 showed no statistical difference between VOS and Restasis®, as both exhibited low drop discomfort scores
Aurinia to advance VOS for the treatment of DES

VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced positive results for its exploratory Phase 2 head-to-head study evaluating the efficacy, safety and tolerability of voclosporin ophthalmic solution (VOS 0.2%) versus Restasis®(cyclosporine ophthalmic emulsion 0.05%) for the treatment of dry eye syndrome (DES). Both drugs were shown to be well-tolerated and there was no statistical difference between VOS and Restasis® for the primary endpoint as both drugs exhibited low drop discomfort scores.

On the key pre-specified secondary endpoints of Schirmer Tear Test/STT (an objective measure of tear production), and Fluorescein Corneal Staining/FCS (an objective measure of structural damage to the cornea), which are FDA-accepted efficacy endpoints, VOS showed rapid and statistically significant improvements over Restasis® at Week 4 (STT: p=.0051; FCS: p=.0003).

This 100-patient, double-masked, head-to-head study was designed to evaluate the efficacy, safety and tolerability of VOS versus Restasis® in subjects with DES. Both arms of the study received either VOS or Restasis® (1:1) administered twice daily, in both eyes, for 28 days. Key pre-specified secondary endpoints, which are FDA-accepted endpoints, include STT, FCS, and assessments of dry eye symptoms.

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Both treatment arms also demonstrated substantial and statistically significant improvements on the Symptom Assessment in Dry Eye (SANDE) score from baseline to Week 4.

No serious adverse events were reported in the study, and there were no unexpected safety signals.

“Improvements in STT and FCS are considered by regulators to be two of the most clinically meaningful measures of efficacy in this disease. The rapid onset and overall efficacy (as measured by the STT and FCS) demonstrated by VOS in this head-to-head study conducted against Restasis® is astounding and could be a game changer in the treatment landscape for dry eye,” said Joseph Tauber, M.D., Principal Investigator and head of the renowned Tauber Eye Institute in Kansas City, MO.

Neil Solomons, M.D., Aurinia’s Chief Medical Officer said, “We are extraordinarily excited with the superior efficacy shown by VOS when compared to Restasis®, which is the current market leader for the treatment of DES in the US. The efficacy endpoints exceeded our expectations and provide further validation of the potential of VOS to provide a highly differentiated and efficacious treatment option for the more than 16 million patients living with this all-too-common disease.”

“Based on these positive data, we plan to aggressively advance VOS for the treatment of DES, which we believe can create considerable value for both patients and our shareholders,” said Richard M. Glickman, Chairman and CEO of Aurinia. “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.”

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TLDR: VOS is more than doubly effective than Restasis. What will the market do? Who the hell knows??

At what point would you expect a buyout? Probably putting the horse before the cart but wouldn't it be reasonable to expect it soon if it were to happen?

What do y'all think of this guy? I think he's a paid hack and a known fraud.

He pumps the drug last week than gives a flat out fake headline. LINK /

How is "flop" equal to superior efficacy? The drugs had equal tolerance, and I guarantee you that after a few weeks VOS will be much more tolerable.

What are they expecting the price to be if both their drugs are proven efficient and working. I heard some people earlier say $30-40?

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What are they expecting the price to be if both their drugs are proven efficient and working. I heard some people earlier say $30-40?

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If both drugs are approved and making money than I think the buyout of the the company would have to come in at 3 billion or above (based on sales and value of drugs).

Since we're worth about 600 million right now at $7 then yeah, $35 would be about right.

Some think it could slow climb to much higher if they don't sell.

Short term, I think there's a good possibility that we're 10-15 by end of this year in anticipation of FDA approval for Voclosporin.

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So good news today and it drop

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story of my life.

How's that quick 6%

I'm in for a small amount of shares @ 7.68 average. Should I go in for more?

down 6% today....currently $6.20....what gives?...been a month since any news