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 VOS showed statistical superiority to R

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

showed statistical superiority to Restasis on FDA-accepted objective

of VOS subjects vs 18.4% of Restasis subjects (p=.0055) demonstrated

10mm improvement in STT at Week 4

endpoint of drop discomfort at 1-minute on Day 1 showed no statistical

difference between VOS and Restasis , as both exhibited low drop

to advance VOS for the treatment of DES

VICTORIA, British Columbia--(BUSINESS WIRE)--January 22, 2019--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.

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

Aurinia will present the results of the clinical trial during a

conference call and webcast presentation to be held at 8:00am ET

Tuesday, January 22, 2019. A link to the live webcast and slides will be

available on the Investors section of the Company's website at http://www.auriniapharma.com.

Aurinia Pharmaceuticals Inc. is a clinical stage

biopharmaceutical company focused on developing and commercializing

therapies to treat targeted patient populations that are suffering from

serious diseases with a high unmet medical need. The company is

currently developing voclosporin, an investigational drug, for

the potential treatment of lupus nephritis (LN), focal segmental

glomerulosclerosis (FSGS), and dry eye syndrome (DES). The company is

headquartered in Victoria, British Columbia and focuses its development

efforts globally. For further information, see our website at www.auriniapharma.com.

VOS (voclosporin ophthalmic solution) is an aqueous,

preservative free nanomicellar solution containing 0.2% voclosporin

intended for use in the treatment of DES. Studies have been completed in

rabbit and dog models, and a single Phase I has also been completed in

healthy volunteers and patients with DES. VOS has IP protection until

About Dry Eye Syndrome (DES)

Dry eye syndrome (DES) is a

chronic disease and is characterized by irritation and inflammation that

occurs when the eye's tear film is compromised by reduced tear

production, imbalanced tear composition, or excessive tear evaporation.

The impact of DES ranges from subtle, yet constant eye irritation to

significant inflammation and scarring of the eye's surface. Discomfort

and pain resulting from DES can reduce quality of life and cause

difficulty reading, driving, using computers and performing daily

activities. While there are FDA approved therapies available for the

treatment of DES, there is opportunity for potential improvement in the

efficacy in addition to other measures such as onset of action,

tolerability and dosing.

Voclosporin, an investigational drug, is a

novel and potentially best-in-class CNI with clinical data in over 2,400

patients across indications. Voclosporin is an immunosuppressant, with a

synergistic and dual mechanism of action. By inhibiting calcineurin,

voclosporin blocks IL-2 expression and T-cell mediated immune responses

and stabilizes the podocyte in the kidney. It has been shown to have a

more predictable pharmacokinetic and pharmacodynamic relationship

(potentially requires no therapeutic drug monitoring), an increase in

potency (vs cyclosporin), and an improved metabolic profile compared to

legacy CNIs. Aurinia anticipates that upon regulatory approval, patent

protection for voclosporin will be extended in the United States and

certain other major markets, including Europe and Japan, until at least