본 보고서는 지속성 각막 상피 결손증(PCED)에 대한 상세한 분석을 제공하며, 총 발병 건수, 성별·병인별 발병 건수 등 과거 및 미래의 역학 데이터를 제시하고 있습니다. 또한 진단 과정, 처방 패턴, 의사의 견해, 시장 접근, 치료 옵션, 시장 전망 동향을 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본의 주요 7개국 시장에 걸쳐 2020-2034년 기간으로 분석했습니다. 또한 기존의 치료실태와 미충족 수요(Unmet Needs)를 종합적으로 평가하여 시장의 잠재력과 새로운 사업 기회를 명확히 하고 있습니다.
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.
Study Period: 2020-2034
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.
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.
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.
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 Dompe 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.
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.
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.
List of drugs to be continued in the report