What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome include topical antibiotics like erythromycin and bacitracin, which are generally well-tolerated but can cause local irritation. Topical cyclosporine and glucocorticoids are also used, with cyclosporine potentially causing burning sensations and glucocorticoids posing risks of increased intraocular pressure and cataract formation. Newer treatments like varenicline nasal spray have shown promise but may cause nasal irritation. Systemic medications, such as those used in allergic and immunological disorders, can lead to dry eyes and other ocular complications. Regular follow-up with an ophthalmologist is recommended to monitor and manage these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Dry Eye Syndrome that either alleviate symptoms or address underlying causes. Cyclosporine (Restasis) is an immunomodulatory agent that increases tear production. Lifitegrast (Xiidra) is another approved treatment that targets inflammation associated with dry eye disease. Recently, varenicline nasal spray (Tyrvaya) was approved to increase tear production by stimulating the trigeminal parasympathetic pathway. These treatments are similar to investigational drugs being studied for their efficacy in alleviating symptoms or addressing the underlying causes of dry eye disease.

What other types of research exist?

Promising novel alternatives for Dry Eye Disease treatment in 2024 include AR-15512, which is currently in a Phase 3 study, flavonoids and cannabinoids for their anti-inflammatory and antiallergic properties, and emerging therapeutic agents such as new topical glucocorticoids, leukotriene receptor antagonists, and interleukin-1 receptor antagonists. These treatments show potential in alleviating symptoms and addressing underlying causes of Dry Eye Disease.

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AR-15512 for Dry Eye Syndrome (COMET-4 Trial)

Phase 3

Waitlist Available

Research Sponsored by Aerie Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 14, 90, 180, 270 & 365

Awards & highlights

Pivotal Trial

Summary

This trial tests a new treatment for people with dry eye disease. Participants will receive the new treatment to see if it works better than no treatment.

Who is the study for?

This trial is for adults over 18 with a history of Dry Eye Disease (DED) within the last year, who have certain levels of eye surface staining and tear production. Participants should be in good general and ocular health but cannot use contact lenses or any topical eye treatments for DED or glaucoma recently.

What is being tested?

The study tests AR-15512 Ophthalmic Solution against a placebo (vehicle) over 12 months to evaluate its long-term safety in treating DED. Patients will visit clinics at set intervals after starting treatment to monitor effects.

What are the potential side effects?

While specific side effects are not listed, potential side effects may include irritation, discomfort, or redness in the eyes; changes in vision; or other ocular symptoms related to the application of ophthalmic solutions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 14, 90, 180, 270 & 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 14, 90, 180, 270 & 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 14, 90, 180, 270 & 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Ultrasound Biomicroscopy

Blood Pressure

+8 more

Other study objectives

Accumulation Ratio (Rcmax)

Minimum Plasma Concentration (Cmin)

Time to Last Detectable Concentration (Tlast)

+2 more

Side effects data

From 2021 Phase 2 trial • 369 Patients • NCT04498182

Peripheral embolism

100%

80%

60%

40%

20%

Study treatment Arm

AR-15512 Ophthalmic Solution Higher Dose - Nonocular

Vehicle - Ocular

Vehicle - Nonocular

AR-15512 Ophthalmic Solution Higher Dose - Ocular

AR-15512 Ophthalmic Solution Lower Dose - Nonocular

Pretreatment

AR-15512 Ophthalmic Solution Lower Dose - Ocular

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AR-15512 Ophthalmic Solution (0.003%)Experimental Treatment1 Intervention

0.003% AR-15512 to be administered BID for 365 days. Both eyes will be treated.

Group II: VehiclePlacebo Group1 Intervention

AR-15512 vehicle to be administered BID for 365 days. Both eyes will be treated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AR-15512 Ophthalmic Solution

2022

Completed Phase 3

~1120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dry Eye Syndrome include cyclosporine, loteprednol, and secretagogues like varenicline. Cyclosporine reduces ocular surface inflammation, enhancing tear production and tear film stability. Loteprednol, a corticosteroid, quickly alleviates symptoms by reducing inflammation. Secretagogues like varenicline stimulate tear production by activating specific receptors. These mechanisms are important for patients to understand as they highlight how these treatments can effectively alleviate symptoms and improve overall eye health.