#1 Clinical Trials Search in Europe

Cenegermin

Cenegermin, a recombinant human nerve growth factor, is being studied in clinical trials for its potential to treat various corneal conditions, particularly neurotrophic keratitis and dry eye disease. This article summarizes key findings from recent trials investigating the safety and efficacy of cenegermin eye drops in improving corneal health and function.

Table of Contents

What is CENEGERMIN?

CENEGERMIN is an innovative eye drop medication that has been developed to treat various corneal nerve disorders. It is also known by its brand name Oxervate™ and is classified as a recombinant human Nerve Growth Factor (rhNGF)[1]. This means it’s a laboratory-made version of a natural protein that helps nerves grow and survive. CENEGERMIN is the first FDA-approved medication specifically designed to treat certain corneal conditions[2].

What Conditions Does CENEGERMIN Treat?

CENEGERMIN is primarily used to treat the following conditions:

  • Neurotrophic Keratitis (NK): This is a condition where the cornea (the clear outer layer of the eye) has reduced sensation due to nerve damage. NK can lead to persistent corneal defects and ulcers[3].
  • Limbal Stem Cell Deficiency (LSCD): When associated with neurotrophic keratopathy, CENEGERMIN may be used to treat this condition where the stem cells in the cornea are damaged or lost[4].
  • Neuropathic Corneal Pain (NCP): This is a condition characterized by eye pain due to nerve damage in the cornea[5].
  • Dry Eye Disease: In some cases, CENEGERMIN is being studied for its potential in treating severe dry eye associated with Sjögren’s syndrome[1].

How Does CENEGERMIN Work?

CENEGERMIN works by promoting the growth and survival of corneal nerves. The cornea is one of the most densely innervated tissues in the body, and these nerves are crucial for maintaining eye health. When applied to the eye, CENEGERMIN:

  • Stimulates corneal nerve regeneration
  • Improves corneal sensitivity
  • Promotes healing of the corneal surface
  • May increase tear production

By addressing the underlying nerve problem, CENEGERMIN helps restore the normal functioning of the cornea[2][6].

How is CENEGERMIN Administered?

CENEGERMIN is typically administered as eye drops. The usual dosage is:

  • One drop in the affected eye(s) every 2 hours, 6 times daily
  • Treatment duration is usually 8 weeks

It’s important to follow your doctor’s instructions precisely when using CENEGERMIN. In some cases, the dosage may be adjusted based on your response to the treatment[7].

How Effective is CENEGERMIN?

Clinical studies have shown promising results for CENEGERMIN:

  • In patients with neurotrophic keratitis, a significant percentage experienced corneal healing after 8 weeks of treatment[3].
  • Improvements in corneal nerve density and function have been observed using specialized imaging techniques[2].
  • Some patients report reduced eye pain and improved quality of life[5].

However, individual results may vary, and your doctor will monitor your progress closely during treatment.

What Are the Potential Side Effects?

While CENEGERMIN is generally well-tolerated, some patients may experience side effects. Common side effects may include:

  • Eye pain or discomfort
  • Excessive tearing
  • Eye redness
  • Foreign body sensation in the eye

If you experience any severe or persistent side effects, contact your healthcare provider immediately[5].

Ongoing Research and Future Prospects

CENEGERMIN continues to be the subject of ongoing research to explore its potential in treating various eye conditions:

  • Studies are investigating its use in earlier stages of neurotrophic keratitis[3].
  • Researchers are examining its effects on corneal nerve structure and function over time[2].
  • Its potential in treating severe dry eye disease is being explored[1].

These ongoing studies may lead to expanded uses for CENEGERMIN in the future, potentially benefiting more patients with corneal nerve disorders.

Aspect Details
Drug Name Cenegermin (Oxervate)
Formulation 0.002% (20 mcg/mL) ophthalmic solution
Main Conditions Studied Neurotrophic keratitis, severe dry eye disease, limbal stem cell deficiency
Dosing Regimen Typically 1 drop 4-6 times daily for 4-8 weeks
Primary Outcomes Corneal epithelial healing, changes in corneal nerve density and function
Secondary Outcomes Symptom improvement, tear production, tear film stability, quality of life measures
Safety Monitoring Adverse events, ocular side effects, tolerability
Imaging Techniques In vivo confocal microscopy, optical coherence tomography
Patient-Reported Measures OSDI, SANDE, OPAS questionnaires

FAQ

  • What is cenegermin and how does it work? Cenegermin is a recombinant human nerve growth factor that promotes corneal nerve regeneration and healing. It is applied as eye drops to treat conditions involving corneal nerve damage or dysfunction.
  • What conditions is cenegermin being studied to treat? Cenegermin is primarily being investigated for neurotrophic keratitis, a condition causing reduced corneal sensation and damage. It's also being studied for severe dry eye disease and limbal stem cell deficiency.
  • How is cenegermin administered in clinical trials? In most trials, cenegermin eye drops are administered 4-6 times daily for 4-8 weeks. The typical concentration used is 20 mcg/mL (0.002%).
  • What are some of the main outcomes being measured in cenegermin trials? Key outcomes include corneal healing, changes in corneal nerve density and function, improvements in symptoms and quality of life, and changes in tear production and quality.
  • Are there any side effects associated with cenegermin use? While generally well-tolerated, some patients may experience eye pain, irritation, or excessive tearing. Trials are monitoring for any adverse events to fully evaluate safety.

Ongoing Clinical Trials on Cenegermin

  • Cenegermin Eye Drops for Persistent Corneal Epithelial Defect in Patients with Persistent Corneal Epithelial Defect

    Recruiting

    3 1 1
    Investigated drugs:
    Czechia France Germany Hungary Italy The Netherlands +2

  • Study of Cenegermin Nasal Spray for Safety and Tolerability in Children with Spastic Cerebral Palsy

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Phase 2a Study of Safety, Tolerability and Efficacy of Intranasal Cenegermin in Adults with Moderate to Severe Subacute Traumatic Brain Injury

    Not yet recruiting

    2 1
    Investigated drugs:
    Denmark Finland France Germany Italy Poland +2

  • Study on the Safety and Effectiveness of Cenegermin Eye Drops for Patients with Dry Eye Disease

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Neurotrophic keratitis (NK): A condition where the cornea has reduced sensation, often leading to persistent epithelial defects and ulcers.
  • Corneal epithelial healing: The process of repairing damage to the outermost layer of the cornea, often measured as the absence of staining abnormalities.
  • In vivo confocal microscopy (IVCM): A non-invasive imaging technique used to examine corneal structures, including nerves, at a cellular level.
  • Schirmer test: A procedure to measure tear production by placing a small strip of filter paper in the lower eyelid.
  • Tear film break-up time (TFBUT): A measure of tear film stability, assessed by the time it takes for dry spots to appear on the cornea after blinking.
  • Ocular Surface Disease Index (OSDI): A questionnaire used to assess symptoms of ocular irritation and their impact on vision-related functioning.
  • Corneal nerve fiber density (CNFD): A measure of the number of nerve fibers in the cornea, often assessed using in vivo confocal microscopy.
  • Limbal stem cell deficiency (LSCD): A condition where stem cells in the limbal area of the cornea are damaged or absent, affecting corneal regeneration.

References

  1. https://clinicaltrials.gov/study/NCT05136170
  2. https://clinicaltrials.gov/study/NCT04627571
  3. https://clinicaltrials.gov/study/NCT04485546
  4. https://clinicaltrials.gov/study/NCT04552730
  5. https://clinicaltrials.gov/study/NCT05700864
  6. https://clinicaltrials.gov/study/NCT04293549
  7. https://clinicaltrials.gov/study/NCT04573647