Vevye for Meibomian Gland Dysfunction

Overseen By Sindhu Gurrala, BDS, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Topical cyclosporine, Xiidra, Miebo, others

Disqualifiers: Contact lenses, Sjögren's, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Vevye, a prescription eye drop, to determine its effectiveness in alleviating symptoms of meibomian gland dysfunction (MGD), which can cause dryness, irritation, or burning in the eyes. Participants will apply the eye drops twice daily for about six months while researchers monitor improvements in eye comfort and health. This trial suits adults who regularly experience eye dryness or irritation due to MGD and have not recently used certain eye medications or treatments. The goal is to assess whether Vevye can enhance comfort for those dealing with this common eye issue. Participants may leave the study at any time.

As a Phase 4 trial, this study aims to understand how the already FDA-approved and effective Vevye can benefit more patients, offering an opportunity to improve eye health with a proven treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using certain eye medications, like topical cyclosporine and other specific eye treatments, at least 30 days before joining. If you're on these medications, you'll need to stop them before participating.

What is the safety track record for this treatment?

Research shows that Vevye, a prescription eye drop containing cyclosporine 0.1%, is generally well-tolerated. In one study, 8% of patients experienced mild reactions at the application site, and about 3% had a temporary decrease in vision. These side effects were not serious and usually resolved quickly.

The FDA has already approved Vevye for another condition, indicating it has been studied and is considered safe. Participants in the study will be closely monitored to ensure any side effects are promptly addressed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Meibomian Gland Dysfunction, which often include warm compresses, eyelid hygiene, and artificial tears, Vevye Ophthalmic Solution offers a novel approach by utilizing cyclosporine 0.1% to target inflammation directly. This active ingredient is known for its effectiveness in reducing inflammatory responses, potentially providing longer-lasting relief compared to typical lubricants or mechanical therapies. Researchers are excited about Vevye because it promises to improve eye health by addressing the underlying issue of inflammation, rather than just alleviating symptoms temporarily.

What is the effectiveness track record for Vevye in treating meibomian gland dysfunction?

Research shows that Vevye, containing 0.1% cyclosporine, effectively treats dry eye symptoms. Studies have found that it enhances the eye's protective layer and reduces dryness and irritation. One study confirmed that this water-free cyclosporine solution can quickly improve the eye's surface. The treatment has also proven effective for dry eye issues following cataract surgery. In this trial, participants with meibomian gland dysfunction (MGD) will receive Vevye, and these findings suggest it could help make eyes feel more comfortable and healthy. ^{1 2 6 7 8}

Who Is on the Research Team?

Jillian F Ziemanski, OD, PhD

Principal Investigator

The University of Alabama at Birmingham, School of Optometry

Are You a Good Fit for This Trial?

Adults with meibomian gland dysfunction (MGD), which often leads to dry, irritated eyes, can join this study. Participants will use Vevye eye drops for six months and attend clinic visits to monitor their eye health.

Inclusion Criteria

I experience severe dryness rated over 70 on a scale.

Corneal fluorescein staining > 6 (NEI scale) for at least one eye

Modified meibomian gland expression score ≥ 23 for both eyes OR ≥ 7 for expressible glands for both eyes OR a combination of the two

Exclusion Criteria

Current or planned pregnancy during the study period

Contact lens wear within two weeks of study enrollment or planned during study period

Habitual visual acuity worse than 0.30 logMAR in either eye

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Participants use a commercially available artificial tear

2 weeks

1 visit (in-person)

Treatment

Participants receive Vevye® (cyclosporine 0.1%) twice daily for 24 weeks

24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vevye Ophthalmic Solution

Trial Overview The trial is testing the effectiveness of Vevye (cyclosporine 0.1% ophthalmic solution) in treating MGD symptoms like dryness and irritation, as well as improving signs such as lid margin changes.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Participants will receive Vevye® (cyclosporine 0.1% ophthalmic solution) twice daily in both eyes for 24 weeks, following a 2-week run-in period using a commercially available artificial tear. All participants will undergo standardized ocular assessments including Visual Analog Scale (VAS) dryness, visual acuity (high- and low-contrast), slit-lamp biomicroscopy, posterior lid margin hyperemia, fluorescein tear breakup time, corneal fluorescein staining, conjunctival staining with lissamine green, lid wiper epitheliopathy, meibomian gland expression, keratograph meibography, and Schirmer I test. This is a non-randomized, open-label, single-group study evaluating the efficacy and safety of Vevye® for the treatment of clinically significant meibomian gland dysfunction

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Harrow Inc

Industry Sponsor

Trials

1

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224529

Efficacy of Vevye Ophthalmic Solution for the Treatment ... This research study evaluates a prescription eye drop called Vevye® (cyclosporine 0.1%) for adults who have meibomian gland dysfunction ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12025775/

Effectiveness of 0.1% Cyclosporine a Cationic Emulsion for ... Conclusions: CsA-CE (0.1%) is effective for treating DED after cataract surgery and improves the tear lipid layer. Keywords: dry eye disease; ...

3. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2803655

Efficacy and Safety of a Water-Free Topical Cyclosporine ... The ESSENCE-2 trial confirmed that treatment with a water-free cyclosporine solution, 0.1%, results in early therapeutic effects on the ocular surface compared ...

4. eyeworld.org eyeworld.org/2024/eyeworld-weekly-june-7-2024/

EyeWorld Weekly, June 7, 2024 Harrow announced publication of the results from its Phase 3 open-label extension study for VEVYE (cyclosporine ophthalmic solution), 0.1%, ...

5. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-025-03862-x

Clinical efficacy of 0.1% cyclosporine A in dry eye patients ... Discomforts in the use of 0.1% CsA were blurring (26, 34.67%), pain (16, 21.33%), foreign body sensation (14, 18.67%), irritation (10, 13.33%), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9114212/

Real-World Effectiveness, Tolerability and Safety of ... Meibomian gland dysfunction (MGD) is a key underlying cause of evaporative DED, while tear underproduction results in aqueous deficient dry eye ...

7. liebertpub.com liebertpub.com/doi/abs/10.1089/jop.2024.0169

Safety and Efficacy of 0.1% Cyclosporine Solutions in Dry ... A Multicenter, Randomized, Clinical Trial Assessing the Effect of rTG-Omega 3 Supplementation on Meibomian Gland Dysfunction Patients after … Suji Hong,; Minji ...

8. vevye.com vevye.com/hcp/safety

Safety VEVYE is shown to be well-tolerated and comfortable with 8% of patients experiencing site instillation reactions and 3% reporting a temporary decrease in ...