voclosporin ophthalmic / Aurinia Pharma - LARVOL DELTA

Systemic Lupus Erythematosus: Ophthalmological Safety Considerations of Emerging and Conventional Therapeutic Agents. (PubMed, Int J Mol Sci) - "With the advent of targeted immunomodulatory agents, the therapeutic landscape of SLE has expanded beyond conventional drugs such as hydroxychloroquine and corticosteroids toward biologics and small molecules designed to interfere with specific immunological pathways...In contrast, recently approved or investigational therapies-such as belimumab, anifrolumab, voclosporin, dual BAFF/APRIL inhibitors, rituximab, JAK inhibitors, CD40/CD40L blockade, CD38 inhibition, and mesenchymal stromal cell-based strategies-have limited but evolving safety data, with potential ocular adverse events spanning inflammatory, vascular, neuro-ophthalmic, and structural domains...These findings highlight the need for systematic ophthalmological surveillance in patients receiving immunomodulatory therapies for SLE. Early recognition and timely management of ocular toxicity are crucial to safeguarding visual function and optimizing long-term therapeutic outcomes in this vulnerable patient..."

Journal • Review • Cataract • Glaucoma • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Ophthalmology • Retinal Disorders • Systemic Lupus Erythematosus • CD40LG

AUDREY: Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome (clinicaltrials.gov) - P2/3; N=508; Completed; Sponsor: Aurinia Pharmaceuticals Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Conjunctivitis • Dry Eye Disease • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Aurinia Announces Outcome of AUDREY Clinical Trial in Dry Eye Syndrome (Businesswire) - P2/3, N=508; AUDREY (NCT04147650); Sponsor: Aurinia; "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 10mm or greater improvement in STT at four weeks between active dose groups of VOS compared to vehicle. Aurinia is suspending the development program for VOS based upon these results."

P2/3 data • Dry Eye Disease • Ophthalmology

AUDREY: Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome (clinicaltrials.gov) - P2/3; N=508; Active, not recruiting; Sponsor: Aurinia Pharmaceuticals Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Jul 2020 ➔ Oct 2020; Trial primary completion date: May 2020 ➔ Sep 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Aurinia reports first quarter 2020 financial results and recent operational highlights (Businesswire) - “We are fortunate that the global COVID-19 pandemic has had minimal impact on Aurinia’s operations, and we have maintained our timelines to ensure the filing of the voclosporin NDA by the end of the second quarter and hopefully obtain approval in early 2021....R&D expenses increased to $13.8 million for the first quarter ended March 31, 2020...primarily reflected higher costs related to the preparation of the NDA submission and related supporting activities...the AURORA 2 extension trial and the expansion of the medical affairs team to support the launch of voclosporin."

Commercial • NDA • P2/3 data • Dry Eye Disease • Immunology • Lupus • Lupus Nephritis • Ophthalmology

Aurinia reports third quarter 2019 financial results and recent operational highlights (Businesswire) - "On October 31, Aurinia announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating VOS for the potential treatment of DES....Top-line results from AUDREY are anticipated during the second half of 2020....Research and development expenses (R&D) increased to $17.8 million for the three months...R&D expenses were $39.6 million for the nine months ended September 30, 2019...The increase in these expenses were primarily related to the manufacturing of voclosporin for commercial and investigational use."

Commercial • P2/3 data

AUDREY: Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome (clinicaltrials.gov) - P2/3; N=480; Recruiting; Sponsor: Aurinia Pharmaceuticals Inc.

Clinical • New P2/3 trial

Aurinia announces initiation of patient dosing in phase 2/3 AUDREY clinical trial for dry eye syndrome (Businesswire) - "Aurinia Pharmaceuticals...today announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution ('VOS') for the potential treatment of dry eye syndrome...Top-line results from the AUDREY clinical study are anticipated during the second half of 2020."

P2/3 data • Trial status

Aurinia reports second quarter 2019 financial results and operational highlights (Aurinia Pharmaceuticals Press Release) - "...Aurinia has initiated plans for a Phase 2/3 study which is expected to enroll its first patient in the fourth quarter of 2019...The Company believes, that based on its current plans that it has sufficient financial resources to fund...the AUDREY Phase 2/3 study, and fund operations into the second half of 2020....In anticipation of the AURORA Phase 3 results in lupus nephritis, we are appropriately scaling the organization ahead of data, which if confirmatory, sets the stage for a NDA filing during the first half of next year."

Enrollment status • Financing • NDA

Aurinia reports first quarter 2019 financial results and recent operational highlights (Aurinia Pharmaceuticals Press Release) - "Based upon the exploratory Phase 2a results generated with VOS...Aurinia plans to initiate a Phase 2/3 study by late 2019. This study will encompass certain critical regulatory requirements that the FDA has traditionally required for DES product approval, these requirements include both dose-optimization requirements along with a comparison versus vehicle."

New P2/3 trial

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease (clinicaltrials.gov) - P2; N=100; Completed; Sponsor: Aurinia Pharmaceuticals Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

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 Press Release) - "Aurinia Pharmaceuticals...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...to evaluate the efficacy, safety and tolerability at four weeks in subjects with dry eye syndrome (DES)."

P2 data

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 (Businesswire) - P2, N=100; NCT03597139; Sponsor: Aurinia Pharmaceuticals Inc; "Aurinia Pharmaceuticals...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...for the treatment of dry eye syndrome (DES)....'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..."

Media quote • P2 data