What side effects are associated with this type of intervention?

Common treatments for corneal ulcers, such as topical nerve growth factor and other ophthalmic gels, generally aim to promote corneal healing. Known side effects of these treatments can include mild local reactions such as eye irritation, redness, and discomfort. In some cases, there may be a risk of increased intraocular pressure or hypersensitivity reactions. However, these side effects are typically mild and resolve upon discontinuation of the treatment. It is important to monitor for any adverse effects and consult with a healthcare provider for appropriate management.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for corneal ulcers that are directly similar to NEXAGON® (lufepirsen ophthalmic gel) in the provided context. NEXAGON® is an antisense oligonucleotide targeting connexin43 to promote corneal healing. While the context includes various treatments for other eye conditions, such as dry eye disease and glaucoma, it does not provide details on FDA-approved antisense oligonucleotide therapies for corneal ulcers.

What other types of research exist?

Promising novel alternatives to NEXAGON® for corneal ulcer treatment in 2024 include: 1) RGTA (ReGeneraTing Agent) therapy, which mimics extracellular matrix components to promote tissue repair; 2) Amniotic membrane transplantation, which provides a biological scaffold for epithelial healing; 3) Recombinant human nerve growth factor (rhNGF) eye drops, which stimulate corneal nerve regeneration and healing; and 4) Gene therapy approaches targeting specific molecular pathways involved in corneal repair. These alternatives have shown potential in clinical studies for enhancing corneal healing and reducing ulceration.

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Monoclonal Antibodies

Lufepirsen Eye Gel for Corneal Ulcer (NEXPEDE-1 Trial)

Phase 2

Recruiting

Research Sponsored by Amber Ophthalmics, Inc.

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 2, 3, 4, 5, 6, 7, 8

Summary

This trial is testing NEXAGON, an eye gel, on patients with persistent eye surface wounds that don't heal with usual treatments. The gel helps the eye's surface cells grow back and heal the wound.

Who is the study for?

This trial is for individuals with persistent corneal epithelial defects (PCED) lasting at least 2 weeks and unresponsive to standard treatments. Participants must not show improvement in the last 2 weeks despite treatment, be capable of consent, and if childbearing potential, not pregnant or sterilized. Exclusions include recent ocular surgery without proper washout time, other eye diseases requiring medication, active infections or history of certain keratoplasty procedures.

What is being tested?

The study tests NEXAGON® (lufepirsen ophthalmic gel) against a placebo vehicle to assess its safety and effectiveness in treating PCED. Patients will be randomly assigned to receive either the experimental gel or a placebo while their health outcomes are monitored.

What are the potential side effects?

While specific side effects for NEXAGON® are not listed here, common side effects from ophthalmic gels may include eye irritation, discomfort upon application, redness, itching or swelling around the eyes. Hypersensitivity reactions could also occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 3, 4, 5, 6, 7, 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 2, 3, 4, 5, 6, 7, 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 5, 6, 7, 8 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Achieve Corneal Re-epithelialization Including Durability (CRC)

Secondary study objectives

Achieve Corneal Re-epithelialization (CRC)

Achieve Corneal Re-epithelialization (Investigator)

Achieve Corneal Re-epithelialization Including Durability (Investigator)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NEXAGON® (lufepirsen ophthalmic gel) High Dose ConcentrationExperimental Treatment1 Intervention

Lufepirsen (High dose concentration) applied topically weekly for 4 to 8 weeks.

Group II: NEXAGON Vehicle (ophthalmic gel)Placebo Group1 Intervention

Vehicle applied topically weekly for 4 to 8 weeks.

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 corneal ulcers include antibiotics, antifungals, antivirals, and anti-inflammatory agents. Antibiotics and antifungals work by eliminating bacterial and fungal pathogens, respectively, which are common causes of corneal ulcers. Antivirals target viral infections that can lead to ulceration. Anti-inflammatory agents reduce inflammation and pain, promoting a more conducive environment for healing. NEXAGON® (lufepirsen ophthalmic gel) specifically targets connexin43, a protein involved in cell communication and wound healing, to promote corneal healing. This is particularly important for corneal ulcer patients as it directly addresses the healing process, potentially reducing recovery time and improving outcomes.

Neprilysin inhibition promotes corneal wound healing.Re-epithelialization of the rabbit cornea is regulated by opioid growth factor.