Aurinia to Hold Conference Call and Webcast to Discuss Results of Phase 2 Head-to-Head Study of Voclosporin Ophthalmic Solution versus Restasis® for the Treatment of Dry Eye Syndrome
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced it will report results before the opening of trading and hold a webcast and conference call to discuss the results of its Phase 2, double-masked, head-to-head study of VOS 0.2% versus Restasis® (cyclosporine ophthalmic emulsion 0.05%) to evaluate the efficacy, safety and tolerability at four weeks in subjects with dry eye syndrome (DES).
Aurinia will host a conference call and webcast presentation at 8:00am ET on Tuesday, January 22, 2019. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.
Aurinia Pharmaceuticals 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.
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 October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension.
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, a single Phase I has also been completed in healthy volunteers and patients with DES, and a single Phase 2 exploratory head-to-head study evaluating the efficacy, safety and tolerability of VOS vs Restasis®(cyclosporine ophthalmic emulsion 0.05%) for the treatment of DES has been completed. VOS has IP protection until 2031.
RESTASIS® and RESTASIS MULTIDOSE™ Ophthalmic Emulsion help increase your eyes' natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye. RESTASIS® and RESTASIS MULTIDOSE™ did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs. https://www.restasis.com/.
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 effectiveness by enhancing tolerability and onset of action and alleviating the need for repetitive dosing.
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