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Persistent Corneal Epithelial Defect - Market Insight, Epidemiology, and Market Forecast - 2034

Publisher DelveInsight
Published Nov 01, 2025
Length 200 Pages
SKU # DEL20575704

Description

Key Highlights
  • Persistent Corneal Epithelial Defects (PCED) are defined as corneal epithelial defects that fail to achieve rapid re-epithelialization and closure within 10 to 14 days after a corneal injury, despite standard supportive treatment.
  • PCED is caused by defective epithelial adhesion (such as recurrent corneal erosions or basement membrane dystrophies), limbal stem cell deficiency, neurotrophic disease (diabetes, herpetic infections, nerve damage), mechanical trauma (surgery, injury, contact lens use), and infections.
  • As per analysis, approximately 60% of the males are affected with persistent corneal epithelial defects.
  • The cornerstone of the treatment strategy includes lubrication (artificial tears and ointments), bandage contact lenses, amniotic membrane transplantation, tarsorrhaphy and corneal transplants, amniotic membrane grafting, autologous serum, and scleral contact lenses.
  • OXERVATE (cenegermin) is the first and only FDA-approved drug for the treatment of persistent corneal epithelial defects (PCED) associated with neurotrophic keratitis.
  • The emerging pipeline for PCED includes ST266 (Noveome Biotherapeutics), KPI-012 (Kala Bio), and others.
  • In July 2025, Kala Bio announced the completion of enrollment in the CHASE clinical trial evaluating KPI-012 for the treatment of PCED, with topline results expected in the third quarter of 2025. Further, the company also believes that the CHASE trial has the potential to serve as a pivotal study to support a Biologics License Application (BLA) with the FDA.
DelveInsight’s ""Persistent Corneal Epithelial Defects (PCED)– Market Insight, Epidemiology, and Market Forecast – 2034"" report delivers an in-depth understanding of PCED, historical and forecasted epidemiology as well as the PCED market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The PCED market report provides current treatment practices, emerging drugs, PCED share of individual therapies, and current and forecasted PCED market size from 2020 to 2034, segmented by seven major markets. The report also covers current PCED treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered
  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan
Study Period: 2020–2034

Persistent Corneal Epithelial Defects (PCED) Disease Understanding and Treatment Algorithm

Persistent Corneal Epithelial Defects (PCED) Overview

The Persistent Corneal Epithelial Defects can be defined as the regions of corneal epithelium that fails to heal within two weeks after a corneal injury, despite conventional treatment. PCED arise due to failure of corneal resurfacing mechanisms, with causes including mechanical trauma, neurotrophic disease, limbal stem cell deficiency (LSCD), inflammation, dry eye, infection, and eyelid abnormalities. The major risk factors include physical trauma (e.g., fingernails, contact lenses), diseases that reduce corneal sensation or eyelid closure, and conditions causing chronic dry eye or poor epithelial regeneration.

The symptoms of PCED include eye pain, tearing, and a foreign body sensation in the affected eye especially during blinking), blurred vision, redness, sensitivity to light, pain with blinking, and pain with eye movement, if left untreated, this condition can increase the risk of serious complications such as corneal infection, ulceration, scarring, perforation, and significant vision loss.

Persistent Corneal Epithelial Defects (PCED) Diagnosis

The diagnosis of persistent corneal epithelial defects involves fluorescein instillation to assess defect size, location, and depth, with deeper PCEDs showing prolonged absorption. A comprehensive physical examination should assess signs such as anterior chamber inflammation, eyelid abnormalities, and reduced corneal sensation, indicative of neurotrophic persistent corneal epithelial defect (PCED). The key distinction between a simple epithelial defect and a true PCED lies in the persistence of the defect for more than two weeks. Detailed patient history, including prior herpetic infections, diabetes, and immune disorders, is crucial.

Less common etiologies, such as limbal stem cell deficiency (LSCD), may present with corneal scarring and neovascularization. PCED are often associated with both ocular surface disease and systemic illnesses, making the identification of underlying autoimmune disorders critical for effective treatment.

Diagnosis includes clinical history, facial and eyelid exams, corneal sensation testing, and evaluation of epithelial defect characteristics. Excluding systemic and local causes, including neurological issues, often necessitates collaboration with a neurologist and cranial imaging. Corneal sensitivity and Schirmer tests, along with vital staining, aid in assessment, while microbiological exams rule out infections.

Further details related to diagnosis will be provided in the report…

Persistent Corneal Epithelial Defects (PCED) Treatment

The treatment of persistent corneal epithelial defects involves a comprehensive approach to enhance healing and prevent complications. Lubrications with preservative-free artificial tears and ointments maintain moisture and aid epithelial repair. Bandage soft contact lenses protect the cornea and reduce friction, while punctal plugs help retain tears by blocking tear drainage. Debridement removes dead epithelial cells to encourage healthy regrowth. In severe or non-healing cases, tarsorrhaphy (partially a surgical procedure that partially or completely sews the eyelids together, may be employed to protect the cornea and reduce exposure. Overall, management is tailored to each patient to restore corneal integrity and preserve vision.

Further details related to treatment will be provided in the report…

Persistent Corneal Epithelial Defects (PCED) Epidemiology

The PCED epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total incident cases of PCED, etiology-specific incident cases of PCED, and gender-specific incident cases of PCED in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
  • Several studies have classified PCED as relatively rare condition with an overall incidence of less than 200,000 cases per year in the US.
  • Among the 7MM, the United States has captured the highest patient share of PCED in 2024.
  • Among all the etiology specific incident cases of PCED (inflammatory disease, Neurotrophic Keratitis, Epithelial/Limbal Stem cell deficiency, and other reasons), inflammatory disease captured the highest number in the 7MM, in 2024.
  • As per the analysis, males are affected more with persistent corneal epithelial defects as compared to females.
Persistent Corneal Epithelial Defects (PCED) Drug Chapters

The drug chapter segment of the PCED report encloses a detailed analysis PCED marketed and emerging pipeline drugs. It also deep dives into PCED’s pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Currently, OXERVATE (cenegermin) (Dompe Farmaceutici) is the first and only FDA-approved drug for treating PCED. The drug chapter also helps understand the PCED clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Marketed Drugs

OXERVATE (cenegermin): Dompe Farmaceutici

OXERVATE (cenegermin) is the first and only approved eye drop used to treat persistent corneal epithelial defects (PCED) associated with neurotrophic keratitis. It contains cenegermin, a recombinant form of human nerve growth factor (NGF) which is identical to the natural protein found in healthy eyes and is vital for the maintenance and repair of corneal nerves and epithelial cells.

OXERVATE was approved based on Phase II clinical trials demonstrating efficacy in promoting corneal healing in patients with NK and PCED. Further, OXERVATE was granted Breakthrough Therapy, Fast Track, and Priority Review designations by the FDA, recognizing its potential to address a serious condition with limited treatment options and to offer significant improvement over existing therapies.

Emerging Drugs

KPI-012: Kala Bio

KPI-012 is a novel, clinical-stage therapy that utilizes a human mesenchymal stem cell secretome (MSC-S) as a topical ophthalmic solution. It contains human-derived biofactors such as growth factors, protease inhibitors, matrix proteins, and neurotrophic factors. It is designed to promote corneal healing and tissue repair in patients with PCED and other severe ocular diseases.

KPI-012 is currently being investigated in Phase IIb clinical trial in patients with PCED. The FDA has granted Orphan drug and Fast Track designations to KPI-012 for the treatment of PCED.

In July 2025, Kala Bio announced the completion of enrollment in the CHASE clinical trial evaluating KPI-012 for treatment of PCED. Further, the company anticipates the topline results from the CHASE trial in the third quarter of 2025.

Drug Class Insight

Nerve growth factor receptor agonists; Neuron stimulants

Nerve growth factor (NGF) receptor agonists and neuron stimulants represent a novel therapeutic class aimed at restoring neural function and epithelial repair in ophthalmic disorders like persistent corneal epithelial defects (PCED), particularly when associated with neurotrophic keratitis (NK). These agents act on the TrkA receptor, promoting nerve regeneration, epithelial healing, and tear film stabilization—key deficiencies in neurotrophic corneal disease.

The most prominent example is OXERVATE (cenegermin), a recombinant human NGF developed by Dompé Farmaceutici. OXERVATE is the first and only approved therapy specifically targeting the underlying neurotrophic pathology of neurotrophic keratitis-related PCED. By mimicking endogenous NGF, cenegermin restores corneal innervation and epithelial integrity, addressing both symptoms and root pathology.

Persistent Corneal Epithelial Defects (PCED) Market Outlook

The current treatment option for persistent corneal epithelial defects includes lubrication (artificial tears and ointments), bandage contact lenses, amniotic membrane transplantation, and surgical interventions like tarsorrhaphy and corneal transplants. For refractory cases, amniotic membrane grafting, autologous serum, scleral contact lenses, and others have been recommended.

There are several FDA-approved drugs for the treatment of patients with PCED include, OXERVATE (cenegermin), a recombinant human nerve growth factor. It is the first FDA-approved targeted therapy for all stages of neurotrophic keratitis including PCED.

The pipeline for persistent corneal epithelial defects treatment includes ST266 (Noveome Biotherapeutics), KPI-012 (Kala Pharmaceuticals) and others.

Overall, it is anticipated that the market for PCED will undergo significant changes during the forecast period 2025–2034 driven by a rising incidence of disease and the introduction of new therapies, which will likely accelerate market growth during this period.

Further details will be provided in the report….

Persistent Corneal Epithelial Defects (PCED) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034. The landscape of PCED treatment has experienced a profound transformation with the uptake of novel medicines. These innovative therapies are redefining standards of care.

Persistent Corneal Epithelial Defects (PCED) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for PCED emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professors, Directors, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or PCED market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the University of Illinois, Queen Victoria Hospital NHS, and Maidstone and Turnbridge Wells Hospitals, etc. were contacted. Their opinion helps understand and validate PCED epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further detailed analysis will be provided in the report….

Scope of the Report
  • The report covers a descriptive overview of PCED, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into PCED epidemiology and treatment.
  • Additionally, an all-inclusive account of both the current and emerging therapies for PCED is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of the PCED market; historical and forecasted is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM PCED market.
Persistent Corneal Epithelial Defects (PCED) Report Insights

Persistent Corneal Epithelial Defects (PCED) Report Insights
  • Patient Population
  • Therapeutic Approaches
  • PCED Pipeline Analysis
  • PCED Market Size and Trends
  • Market Opportunities
  • Impact of Upcoming Therapies
Persistent Corneal Epithelial Defects (PCED) Report Key Strengths
  • Ten Years Forecast
  • 7MM Coverage
  • PCED Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake
Persistent Corneal Epithelial Defects (PCED) Report Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)
FAQs
  • What was the PCED market share (%) distribution in 2020 and what it would look like in 2034?
  • What would be the PCED total market size as well as market size by therapies across the 7MM during the study period (2020–2034)?
  • What are the key findings about the market across the 7MM and which country will have the largest PCED market size during the study period (2020–2034)?
  • At what CAGR, the PCED market is expected to grow at the 7MM level during the study period (2020–2034)?
  • What would be the PCED market growth till 2034?
  • What are the disease risks, burdens, and unmet needs of PCED?
  • What is the historical PCED patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
  • What will be the growth opportunities across the 7MM concerning the patient population of PCED?
  • Amon the 7MM which country would have the most incident cases of PCED?
  • At what CAGR the population is expected to grow across the 7MM during the study period (2020–2034)?
  • How many companies are developing therapies for the treatment of PCED?
  • How many emerging therapies are in the mid-stage and late stage of development for the treatment of PCED?
  • What are the key collaborations (industry–industry, industry-academia), Mergers and acquisitions, and licensing activities related to PCED therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed for PCED to overcome the limitations of existing therapies?
  • What are the key designations that have been granted for the emerging therapies for PCED?
  • What are the 7MM historical and forecasted market of PCED?
Reasons to buy
  • The report will help in developing business strategies by understanding trends shaping and driving the PCED market.
  • To understand the future market competition in the PCED market and insightful review of the SWOT analysis of PCED.
  • Organize sales and marketing efforts by identifying the best opportunities for PCED in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for the PCED market.
  • To understand the future market competition in the PCED treatment landscape.


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Table of Contents

200 Pages
1. Key Insights
2. Report Introduction
3. Persistent Corneal Epithelial Defects (PCED) Market Overview at a Glance
3.1. Market Share (%) Distribution of PCED by Therapies in 2024
3.2. Market Share (%) Distribution of PCED by Therapies in 2034
4. Executive Summary of Persistent Corneal Epithelial Defects (PCED)
5. Key Events
6. Disease Background and Overview
6.1. Introduction
6.2. Etiology
6.3. Clinical Presentation
6.4. Pathophysiology
6.5. Diagnosis
6.5.1. Diagnostic criteria
6.5.2. Differential Diagnosis
7. Treatment
7.1. Treatment Guidelines and Recommendations
8. Epidemiology and Market Forecast Methodology of Persistent Corneal Epithelial Defects (PCED)
9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Incident Cases of PCED in the 7MM
9.4. The United States
9.4.1. Total Incidence Cases of PCED in the United States
9.4.2. Gender-specific Cases of PCED in the United States
9.4.3. Etiology-specific Incidence of PCED in the United States
9.5. EU4 and the UK
9.5.1. Total Incidence Cases of PCED in EU and the UK
9.5.2. Gender-specific Cases of PCED in EU and the UK
9.5.3. Etiology-specific Incidence of PCED in EU and the UK
9.6. Japan
9.6.1. Total Incidence Cases of PCED in EU and the UK
9.6.2. Gender-specific Cases of PCED in EU and the UK
9.6.3. Etiology-specific Incidence of PCED in EU and the UK
10. Patient Journey of Persistent Corneal Epithelial Defects (PCED)
11. Marketed Therapies of Persistent Corneal Epithelial Defects (PCED)
11.1. Key Cross of Marketed Therapy
11.2. OXERVATE: Dompe Farmaceutici
11.2.1. Product Description
11.2.2. Regulatory Milestone
11.2.3. Other Development Activities
11.2.4. Clinical Development
11.2.4.1. Clinical Trial Information
11.2.5. Safety and Efficacy
11.2.6. Analyst Views
12. Emerging Therapies of Persistent Corneal Epithelial Defects (PCED)
12.1. Key Cross of Emerging Therapies
12.2. ST266: Noveome Biotherapeutics
12.2.1. Drug Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.3.1. Clinical Trials Information
12.2.4. Safety and Efficacy
12.2.5. Analyst Views
12.3. KPI-012: Kala Bio
12.3.1. Drug Description
12.3.2. Other Developmental Activities
12.3.3. Clinical Development
12.3.3.1. Clinical Trials Information
12.3.4. Safety and Efficacy
12.3.5. Analyst Views
List of drugs to be continued in the report
13. Persistent Corneal Epithelial Defects (PCED): Seven Major Market Analysis
13.1. Key Findings
13.2. Key Market Forecast Assumptions of Persistent Corneal Epithelial Defects (PCED)
13.2.1. Cost Assumptions and Rebate
13.2.2. Pricing Trends
13.2.3. Analogue Assessment
13.2.4. Launch Year and Therapy Uptake
13.3. Market Outlook of Persistent Corneal Epithelial Defects (PCED)
13.4. Conjoint Analysis
13.5. Total Market Size of PCED in the 7MM
13.6. The United States Market Size
13.6.1. Total Market Size of PCED in the United States
13.6.2. Market Size of PCED by Therapies in the United States
13.7. EU4 and the UK Market Size
13.7.1. Total Market Size of PCED in EU4 and the UK
13.7.2. Market size of PCED by Therapies in EU4 and the UK
13.8. Japan Market Size
13.8.1. Total Market Size of PCED in Japan
13.8.2. Market Size of PCED by Therapies in Japan
14. Unmet Needs of Persistent Corneal Epithelial Defects (PCED)
15. SWOT Analysis of Persistent Corneal Epithelial Defects (PCED)
16. KOL Views of Persistent Corneal Epithelial Defects (PCED)
17. Market Access and Reimbursement
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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