What is the mechanism of action of this treatment?

Common treatments for Fuchs' Dystrophy focus on promoting corneal endothelial cell health and regeneration. Medications like hypertonic saline drops reduce corneal swelling, while surgical options such as Descemet's membrane endothelial keratoplasty (DMEK) and Descemet stripping only (DSO) replace or remove damaged endothelial cells. Emerging therapies, such as the K-321 eye drops, likely aim to enhance endothelial cell survival, reduce cell death, and stimulate cell proliferation. These treatments are vital as they address the root cause of the disease, potentially improving vision and reducing the need for invasive surgeries.

What side effects are associated with this type of intervention?

Common treatments for Fuchs' Dystrophy, such as corneal transplants, DMEK, and DSAEK, can have side effects including graft rejection, infection, increased intraocular pressure, and graft detachment. Non-surgical treatments like Rho kinase inhibitors, which aim to promote endothelial cell health, may cause eye irritation, redness, and transient blurred vision.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs that directly treat Fuchs' Endothelial Corneal Dystrophy (FECD) by promoting corneal endothelial cell health or regeneration. The primary treatment for advanced FECD remains surgical, including procedures like Descemet's Stripping Endothelial Keratoplasty (DSEK) or Descemet Membrane Endothelial Keratoplasty (DMEK). These surgeries involve replacing the damaged endothelial layer of the cornea with healthy donor tissue. Research and clinical trials, such as the study of K-321 eye drops, are ongoing to explore non-surgical therapeutic options that could potentially promote endothelial cell health and regeneration.

What other types of research exist?

Promising novel alternatives to K-321 for Fuchs' Dystrophy patients may include therapies that inhibit myofibroblast differentiation, such as dasatinib, which has shown efficacy in reducing cellular contractility and ECM synthesis. Additionally, other regenerative therapies or advanced cell-based treatments targeting corneal endothelial health could be considered.

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Rho Kinase Inhibitor

K-321 Eye Drops for Fuchs' Dystrophy

Phase 3

Waitlist Available

Research Sponsored by Kowa Research Institute, Inc.

Eligibility Criteria Checklist

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

Must have

Is at least 18 years old at the screening visit (Visit 1)

Has a diagnosis of FECD at Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing K-321 to see if it helps people with FECD recover better after cataract surgery and descemetorhexis by supporting the healing of their cornea. K-321 has shown promise in treating corneal conditions like Fuchs' Endothelial Corneal Dystrophy (FECD).

Who is the study for?

This trial is for adults over 18 with Fuchs Endothelial Corneal Dystrophy (FECD) who are undergoing cataract surgery and descemetorhexis. Participants must meet all other criteria specified in the study protocol.

What is being tested?

The trial is testing K-321 eye drops to see if they're safe and effective when used after cataract surgery and descemetorhexis in patients with FECD, compared to a placebo.

What are the potential side effects?

Potential side effects of K-321 eye drops may include discomfort in the eyes, redness, or changes in vision. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with Fuchs' dystrophy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12

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: K-321Experimental Treatment1 Intervention

K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Group II: PlaceboPlacebo Group1 Intervention

Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ripasudil

2022

Completed Phase 3

~340

0 / 2Eligibility criteria met

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 Fuchs' Dystrophy focus on promoting corneal endothelial cell health and regeneration. Medications like hypertonic saline drops reduce corneal swelling, while surgical options such as Descemet's membrane endothelial keratoplasty (DMEK) and Descemet stripping only (DSO) replace or remove damaged endothelial cells. Emerging therapies, such as the K-321 eye drops, likely aim to enhance endothelial cell survival, reduce cell death, and stimulate cell proliferation. These treatments are vital as they address the root cause of the disease, potentially improving vision and reducing the need for invasive surgeries.