AZR-MD-001 / Azura Ophthalmics - LARVOL DELTA

Characteristics of Participants with Mild to Moderate MGD Utilizing AZR-MD-001 0.5% in a Randomized, Placebo-Controlled, Phase 3 Trial (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P3 data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Dosing Methods, Instructions for Use, and Safety Data Outcomes from a Phase 3 Study Evaluating the Efficacy and Safety of AZR-MD-001 0.5% for the Treatment of MGD and DED (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P3 data • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

The effect of a biweekly novel selenium sulfide-containing topical treatment in symptomatic contact lens wearers: An exploratory study. (PubMed, Ocul Surf) - "This exploratory study indicates that twice-weekly use of AZR-MD-001 ointment can rapidly improve gland patency and secretion in symptomatic contact lens-wearers. AZR-MD-001 reduced changeable/blurry vision and prolonged CWT, suggesting relevant future endpoints."

Journal • Dry Eye Disease • Ophthalmology

An update on emerging pharmacological treatments for meibomian gland dysfunction. (PubMed, Expert Opin Pharmacother) - "Great expectations also accompany the phase 3 study of AZR-MD-001, understood to be a keratolytic and lipogenic agent able to improve meibum quantity and quality. The chance to specifically target MGD represents an important step forward and will allow more tailored treatment for each type of ocular surface disease."

Journal • Review • Dry Eye Disease • Ophthalmology

AZR-MD-001 0.5% selenium sulfide ophthalmic ointment for the treatment of contact lens discomfort: A vehicle-controlled, randomized, clinical trial. (PubMed, Ocul Surf) - "AZR-MD-001 0.5% significantly improved MGD signs and hours of comfortable CL wear, demonstrating good efficacy, safety, and tolerability in those with CLD."

Journal • Dry Eye Disease • Ophthalmology

Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction over six months of treatment: A Phase 2, vehicle-controlled, randomized extension trial. (PubMed, Ocul Surf) - "AZR-MD-001 (0.5%) was efficacious in treating signs and symptoms of MGD over six months, with a lower observed incidence of new adverse events over time."

Journal • P2 data • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology • Pain

A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED) (clinicaltrials.gov) - P3 | N=500 | Active, not recruiting | Sponsor: Azura Ophthalmics | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED) (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Azura Ophthalmics | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

Sign and Symptom Improvement Rates Among MGD Patients Following Treatment With AZRMD001 for 6 Months (ARVO 2024) - P2 | "Over 6 months, a greater proportion of patients applying both concentrations of AZR-MD-001 demonstrated a clinically meaningful response, with normalization of their meibomian gland function, meibum secretions, and the resolution of disease symptomology."

Clinical • Ophthalmology

AZR-MD-001 Opens Meibomian Glands, Improves Meibum and Tear Quality Resulting in Increased Wear Time and Desired Lens Use in Patients With CLD (ARVO 2024) - P2 | "AZR-MD-001 significantly improved the meibum and tear film quality, resulting in improved wear time in patients with CLD compared to vehicle starting as early as 8 doses of treatment. AZR demonstrated efficacy, safety, and tolerability, with no major adverse events observed. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Ophthalmology

AZR-MD-001 Ophthalmic Ointment Opens Meibomian Glands, Improves Meibum Quality, and Tear Film Stability Over 3 Months of Dosing in Patients with Contact Lens Discomfort (ARVO 2024) - P2 | "AZR-MD-001 significantly improved signs of MGD and tear film stability in CLD beginning as early as 14 days (4 applications) with improvement to 3 months compared to vehicle. AZR-MD-001 demonstrated good efficacy, safety, and tolerability, with no significant adverse events observed in this 3-month trial. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Dry Eye Disease • Ophthalmology

Safety and Efficacy of Topical AZR-MD-001 for the Treatment of Meibomian Gland Dysfunction in a 6-Month Study (ARVO 2024) - P2 | "Six months of biweekly dosing of AZR 0.5% significantly improved signs and symptoms of MGD compared to vehicle. AZR was found to be safe through 6 months of therapy, and tolerability improved with prolonged exposure, in alignment with topical selenium dermatology agents."

Clinical • Ophthalmology

AZR-MD-001 Improved Corneal and Conjunctival Damage in Patients with CLD and MGD (ARVO 2024) - P2 | "AZR 0.5% treatment significantly improved corneal and conjunctival damage in patients with CLD and increased contact lens wear time for an additional 3.2 hours compared to vehicle. AZR 0.5% demonstrated efficacy, safety, and tolerability, with no major adverse events observed. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Corneal Abrasion • Ophthalmology

AZR-MD-001 Efficacy in Resolving the Signs and Associated Symptoms of Contact Lens Discomfort in a Phase 2 Trial (ARVO 2024) - P2 | "AZR MD 001 significantly improved the proportion of subjects with open glands and normal meibum secretion quality resulting in more patients who could wear their CLs comfortably for as long as they desired compared to vehicle. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details.: This study examined AZR-MD-001, an ointment, to see if it helps people with contact lens discomfort (CLD) due to gland issues in their eyes."

Clinical • P2 data • Dry Eye Disease • Ophthalmology

AZR-MD-001 Improved Tear Film Stability and Ocular Symptoms in Patients with Meibomian Gland Dysfunction: 6-Month Results (ARVO 2024) - P2 | "Biweekly treatment with AZR-MD-001 0.5% significantly improved tear film quality compared to vehicle, which resulted in clinically significant improvements in ocular symptoms through 6 months of treatment."

Clinical • Dry Eye Disease • Ophthalmology

A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED) (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Azura Ophthalmics

New P3 trial • Dry Eye Disease • Ophthalmology

A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED) (clinicaltrials.gov) - P2 | N=321 | Completed | Sponsor: Azura Ophthalmics | N=245 ➔ 321

Enrollment change • Dry Eye Disease • Ophthalmology

Resolution of Signs and Symptoms of MGD Meibomian Gland Dysfunction Following 6 Months of AZR-MD-001 Treatment vs. Vehicle: A Randomized Study (AAO 2023) - "Many patients became asymptomatic for disease (0.5%: 48.2%, P = .0333; 1.0%: 50.1%, P = .0205; vehicle: 29.5%). Conclusion AZR-MD-001-treated patients demonstrated statistically significant and clinically meaningful improvements in disease over 6 months."

Clinical • Ophthalmology

Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD) (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Azura Ophthalmics | Active, not recruiting ➔ Completed

Trial completion

Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD) (clinicaltrials.gov) - P2 | N=67 | Active, not recruiting | Sponsor: Azura Ophthalmics | Recruiting ➔ Active, not recruiting

Enrollment closed

Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. (PubMed, Ocul Surf) - P2 | "Co-primary endpoints were met for AZR-MD-001 0.5% at Month 3, with a statistically significant improvement in the signs and symptoms of MGD. AZR-MD-001 was safe and well tolerated."

Clinical • Journal • Ophthalmology

Azura Ophthalmics to Present New Data on AZR-MD-001 in Meibomian Gland Dysfunction at American Society of Cataract and Refractive Surgery and Association for Research in Vision and Ophthalmology Annual Meetings (Businesswire) - "Azura Ophthalmics Ltd...announced multiple presentations featuring positive efficacy and safety data from a Phase 2b study of the company’s lead drug candidate, AZR-MD-001, in Meibomian Gland Dysfunction (MGD). Data will be featured at the upcoming Annual Meetings for the Association for Research in Vision and Ophthalmology (ARVO), April 23-27 in New Orleans and the American Society of Cataract and Refractive Surgery (ASCRS), May 5-8 in San Diego....'We are excited to present our data across multiple presentations at these prestigious conferences and we expect to advance AZR-MD-001 into a pivotal Phase 3 trial this year'."

New P3 trial • P2b data • Dry Eye Disease • Ophthalmology

AZR-MD-001 restores gland gunction and improves signs and ocular symptoms of mebomian gland dysfunction (MGD) (ARVO 2023) - "A novel eye ointment containing selenium sulphide, used twice a week for 90 days in adults with meibomian gland dysfunction, caused the signs and symptoms of the disease to resolve in almost half of the patients. This degree of improvement is considerable compared with existing treatments and this is a promising advance for sufferers of this common, chronic disease"

Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

AZR-MD-001 efficacy in improving tear film stability and its impact on associated symptoms of meibomian gland dysfunction in a Phase 2 trial (ARVO 2023) - "A novel eye ointment containing selenium sulphide, used twice a week for 90 days in adults with meibomian gland dysfunction, caused the signs and symptoms of the disease to resolve in almost half of the patients. The degree of improvement is considerable compared with existing treatments and this is a promising advance for sufferers with dry eye disease due to this common, chronic disease."

Clinical • P2 data • Dry Eye Disease • Ophthalmology