Persistent Corneal Epithelial Defects (PCEDs) - Pipeline Insight, 2024

This “Persistent corneal epithelial defects (PCEDs)- Pipeline Insight, 2024” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Persistent corneal epithelial defects (PCEDs) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Persistent corneal epithelial defects (PCEDs): Understanding

Persistent corneal epithelial defects (PCEDs): Overview

The cornea is the transparent, outermost layer of the eye that uniformly refracts the majority of light that enters the eye onto the lens and is essential for ideal vision. The multi-layered corneal epithelium acts as a protective barrier to infectious agents via tight junctions between neighboring cells, and it maintains its smooth optical surface by constantly regenerating cells in the basal cell layer. Persistent Corneal Epithelial Defects (PCEDs) (PEDs or PCEDs) result from the failure of rapid re-epithelialization and closure within 10-14 days after a corneal injury, even with standard supportive treatment. Disruptions in the protective epithelial and stromal layers of the cornea can render the eye susceptible to infection, stromal ulceration, perforation, scarring, and significant vision loss.

Epithelial Wound Healing
In the Case of Injury to the Cornea, Interleukin 1 (IL-1) is secreted by the Damaged Epithelial Cells, Causing some Keratocytes to Undergo Apoptosis and some to Proliferate into Activated Keratocytes. Epithelial Cells will also Secrete Transforming Growth Factor-beta (TGF-ß) in Response to Destruction of the Basement Membrane and Results in Myofibroblast transformation. Growth Factors Insulin-like Growth Factor (IGF), Insulin, Epidermal Growth Factor (EGF), platelet-Derived Growth Factor (PDGF), Keratinocyte Growth Factor (KGF), and Hepatocyte Growth Factor (HGF) Play Important Roles in Corneal Wound Healing. EGF, IGF and Insulin Regulate Epithelial Growth and Stromal Keratocyte Activation. KGF and HGF are produced by Keratocytes to influence Migration and Proliferation of Epithelial Cells. PDGF Regulates Epithelial Proliferation and Keratocyte Function.

Etiology
The normal corneal wound healing process can be disrupted from defective epithelial adhesion, limbal stem cell deficiency, surface trauma, medications, infections, and several other etiologies discussed below. The pathophysiology of PED involves proliferation of myofibroblasts and a resulting disordered extracellular matrix, producing an opacity in the cornea.

Diagnosis
Evaluating a Persistent Corneal Epithelial Defects (PCEDs) involves fluorescein instillation to monitor the size, location, and depth of the defect. In deeper Persistent Corneal Epithelial Defects (PCEDs), it takes a longer time for the fluorescein to absorb into the epithelium and stroma. A thorough physical exam should reveal findings such as inflammation in the anterior chamber, eyelid abnormalities, or decreased sensation of the cornea, such as in the case of a neurotrophic Persistent Corneal Epithelial Defects (PCEDs).

Treatment
The current standard management of Persistent Corneal Epithelial Defects (PCEDs) includes a stepwise strategy, starting with conservative management and progressing to medical or surgical treatments if refractory. This includes lubrication, bandage soft contact lenses, punctal plugs, debridement, and tarsorrhaphy. Initially, aggressive lubrication every 1-2 hours with preservative-free artificial tears and ocular ointments are applied to the eye.

Bandage soft contact lenses (BCL) along with preservative-free artificial tears and antibiotics are beneficial in protecting the damaged epithelium from mechanical erosion from eyelid blinking, thus aiding the re-epithelialization process.

Surgical interventions, such as debridement and tarsorrhaphy, are effective in most cases of Persistent Corneal Epithelial Defects (PCEDs) refractory to medical management.

Tetracyclines, prophylactic topical antibiotics, and steroids are also used as standard therapy for Persistent Corneal Epithelial Defects (PCEDs). Oral tetracyclines exhibit anticollagenolytic activity, inhibiting MMPs produced by inflammation mediators, and have been shown to be effective in healing Persistent Corneal Epithelial Defects (PCEDs) within weeks.

Persistent corneal epithelial defects (PCEDs)- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Persistent corneal epithelial defects (PCEDs) pipeline landscape is provided which includes the disease overview and Persistent corneal epithelial defects (PCEDs) treatment guidelines. The assessment part of the report embraces, in depth Persistent corneal epithelial defects (PCEDs) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Persistent corneal epithelial defects (PCEDs) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Persistent corneal epithelial defects (PCEDs) R&D. The therapies under development are focused on novel approaches to treat/improve Persistent corneal epithelial defects (PCEDs).

Persistent corneal epithelial defects (PCEDs) Emerging Drugs Chapters

This segment of the Persistent corneal epithelial defects (PCEDs) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Persistent corneal epithelial defects (PCEDs) Emerging Drugs

KPI-012: Kala Pharmaceuticals
Kala’s development pipeline includes KPI-012, in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing. Kala is also evaluating KPI-012 for potential expansion to additional indications for rare front of the eye diseases, such as partial limbal stem cell deficiency and moderate-to-severe Sjögren's. KPI-012 is currently under investigation for PCED in Phase II trial which is expected to be completed in February 2024.

In November 2021, Kala Pharmaceuticals acquired Combangio, Inc. to further develop its lead asset, now known as KPI-012, a mesenchymal stem cell secretome (MSC-S). The company is focused on developing biologic therapies utilizing this proprietary MSC-S platform.

Nexagon: Eyevance/Amber Ophthalmics
NEXAGON, is a first in class unmodified antisense oligodeoxynucleotide that inhibits a cell membrane hemichannel forming protein, connexin43 (Cx43). Cx43 is overexpressed after acute injury or in chronic disease states leading to pathological prematurely open hemichannels, allowing ATP to enter the extracellular space. Extracellular ATP triggers and perpetuates the immune system's inflammasome pathway releasing multiple proinflammatory cytokines resulting in microvascular breakdown, vessel leak and limbal tissue ischemia. NEXAGON inhibits Cx43 overexpression and the inflammatory cascade, re-establishing limbal microvasculature and promoting regeneration of the corneal epithelium.

Amber Ophthalmics, of San Diego, which is currently developing Nexagon reported that it saw positive topline results in a Phase II trial of Nexagon (lufepirsen ophthalmic gel) for persistent corneal epithelial defect (PCED) secondary to chemical and/or thermal injury. Nexagon has been granted orphan drug status by the US FDA. Amber said it plans to begin a Phase II/III trial in subjects with PCED of various etiologies in Q1-2023.

Persistent corneal epithelial defects (PCEDs): Therapeutic Assessment

This segment of the report provides insights about the different Persistent corneal epithelial defects (PCEDs) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Persistent corneal epithelial defects (PCEDs)

There are approx. 5+ key companies which are developing the therapies for Persistent corneal epithelial defects (PCEDs). The companies which have their Persistent corneal epithelial defects (PCEDs) drug candidates in the advanced stage, i.e. phase II.

Phases

This report covers around 50+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Persistent corneal epithelial defects (PCEDs) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Persistent corneal epithelial defects (PCEDs): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Persistent corneal epithelial defects (PCEDs) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Persistent corneal epithelial defects (PCEDs) drugs.

Persistent corneal epithelial defects (PCEDs) Report Insights

• Persistent corneal epithelial defects (PCEDs) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Persistent corneal epithelial defects (PCEDs) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Persistent corneal epithelial defects (PCEDs) drugs?
• How many Persistent corneal epithelial defects (PCEDs) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Persistent corneal epithelial defects (PCEDs)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Persistent corneal epithelial defects (PCEDs) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Persistent corneal epithelial defects (PCEDs) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Eyevance/Amber Ophthalmics
• Kala Pharmaceuticals
• Noveome Biotherapeutics
• Oyster Point Pharma

Key Products

• Nexagon
• KPI-012
• ST266
• OC-01

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