AZR-MD-001 for Dry Eye Syndrome

Not currently recruiting at 18 trial locations

Overseen By Charles Bosworth, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Azura Ophthalmics

Must not be taking: MGD treatments, Dry eye treatments

Disqualifiers: Glaucoma, Ocular hypertension, Recent surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with dry eye syndrome, focusing on issues with the meibomian glands, tiny oil glands in the eyelids. The study compares a special ointment, AZR-MD-001, to a placebo to determine if it improves gland function and eases symptoms. Participants will apply the ointment twice a week at bedtime for up to a year. This trial may suit those with dry eye symptoms and blocked meibomian glands in both eyes. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop using any systemic or topical treatments for Meibomian Gland Dysfunction (MGD) or dry eye during the study.

Is there any evidence suggesting that AZR-MD-001 is likely to be safe for humans?

Research has shown that AZR-MD-001 is being tested for its effects on dry eye syndrome, specifically targeting the meibomian glands, which help keep eyes moist. Studies have found that AZR-MD-001 can significantly improve dry eye symptoms by reducing tear evaporation and enhancing gland function.

Regarding safety, past patients generally tolerated this treatment well, with no major safety issues reported in the studies. This suggests that AZR-MD-001 is usually safe, though individual experiences may vary. Prospective participants should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dry eye syndrome?

Unlike other treatments for dry eye syndrome, which often involve artificial tears or anti-inflammatory medications, AZR-MD-001 is a sterile ophthalmic ointment designed for twice-weekly application at bedtime. This ointment contains a unique 0.5% formulation that could offer a more convenient and potentially more effective solution by reducing the frequency of application compared to daily treatments. Researchers are excited about its potential to provide longer-lasting relief and improve patient adherence due to its less frequent dosing schedule.

What evidence suggests that AZR-MD-001 might be an effective treatment for dry eye syndrome?

Research has shown that AZR-MD-001, which participants in this trial may receive, may help treat dry eye syndrome by improving the function of the meibomian glands, crucial for eye health. In earlier studies, using AZR-MD-001 at a 0.5% concentration led to noticeable improvements in dry eye symptoms after three months. The treatment unblocked these glands, reducing dry eye symptoms. Patients reported fewer new side effects over time. With just four applications, gland function clearly improved, and this benefit lasted for three months. These results suggest that AZR-MD-001 could effectively manage dry eye syndrome. ^{1 5 6 7 8}

Who Is on the Research Team?

Charles Bosworth, PhD

Principal Investigator

Azura Ophthalmics

Are You a Good Fit for This Trial?

This clinical trial is for individuals with abnormal meibomian gland function leading to Dry Eye Disease (DED). Specific details about who can join or reasons why someone might not be able to participate are not provided.

Inclusion Criteria

Evidence of meibomian gland obstruction in both eyes at Screening and Baseline

I have been diagnosed with active Evaporative Dry Eye Disease.

Exclusion Criteria

My eye condition is under control, except for dry eyes or MGD.

I have glaucoma, high eye pressure, or my eye pressure is 24 mm Hg or higher.

I am not willing to stop my current treatments for dry eye during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZR-MD-001 or vehicle twice weekly at bedtime for up to 12 months

12 months

Visits on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ongoing TEAEs followed for an additional 30 days

1 month

What Are the Treatments Tested in This Trial?

Interventions

• AZR-MD-001
• Vehicle

Trial Overview The study compares the effects of an ointment called AZR-MD-001 against a placebo (vehicle) in treating dry eye symptoms. Participants will use their assigned treatment at bedtime twice a week for up to one year, and the process is double-masked so neither participants nor researchers know who gets which treatment.

How Is the Trial Designed?

Group I: AZR-MD-001 Experimental Treatment 1 Intervention

AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.

Group II: Vehicle Placebo Group 1 Intervention

AZR-MD-001 Vehicle to be administered twice weekly at bedtime.

Who Is Running the Clinical Trial?

Azura Ophthalmics

Lead Sponsor

Trials

6

Recruited

980+

ORA, Inc.

Industry Sponsor

Trials

72

Recruited

9,200+

Stuart Abelson

ORA, Inc.

Chief Executive Officer since 2007

BSc in Neuroscience from Bates College, MBA from Northwestern University

Dr. Gustavo De Moraes

ORA, Inc.

Chief Medical Officer since 2022

MD, PhD in Ophthalmic Sciences, MPH in Biostatistics

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03652051

A Multicenter Study Evaluating AZR-MD-001 in Patients ... Evidence of meibomian gland obstruction; Reported dry eye signs and symptoms within the past 3 months. Exclusion Criteria: Uncontrolled ocular disease (except ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37478969/

Efficacy and safety of AZR-MD-001 selenium sulfide ... Conclusions: Co-primary endpoints were met for AZR-MD-001 0.5% at Month 3, with a statistically significant improvement in the signs and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06329791

NCT06329791 | A Phase 3 Study to Evaluate AZR-MD-001 ... This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39613259/

Efficacy and safety of AZR-MD-001 selenium sulfide ... 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.

5. azuraophthalmics.com azuraophthalmics.com/press-releases/azura-ophthalmics-announces-positive-results-from-phase-2b-clinical-trial-of-azr-md-001-in-meibomian-gland-dysfunction/

Azura Ophthalmics With as little as four applications of AZR-MD-001, improvement in glandular function was observed and continued to improve over three months.

6. ctv.veeva.com ctv.veeva.com/study/a-randomized-study-to-evaluate-azr-md-001-in-patients-with-abnormal-meibomian-gland-function-and-dry

A Phase 3 Study to Evaluate AZR-MD-001 in Patients with ... This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164226/

Dry Eye Disease Associated with Meibomian Gland Dysfunction Evaluation at 2 weeks showed that AZR-MD-001 significantly decreased the tear evaporation rate and increased TFBUT and the number of meibomian glands yielding ...

8. azuraophthalmics.com azuraophthalmics.com/press-releases/azura-ophthalmics-to-present-new-data-supporting-the-potential-of-azr-md-001-to-be-the-first-ophthalmic-keratolytic-for-ocular-surface-diseases/

Azura Ophthalmics to Present New Data Supporting the ... New and updated data show investigational AZR-MD-001 demonstrates durability of response in improving ocular signs and symptoms of Meibomian Gland Dysfunction ...