Limbal Stem Cell Deficiency - Pipeline Insight, 2024

This “Limbal Stem Cell Deficiency- Pipeline Insight, 2024” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Limbal Stem Cell Deficiency 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

Limbal Stem Cell Deficiency: Understanding

Limbal Stem Cell Deficiency Overview

Limbal stem cell deficiency (LSCD) is a complex corneal disorder resulting from functional and/or anatomical loss of limbus due to chemical or thermal burn, radiation, genetic/autoimmune disorders, multiple surgeries, contact lens use, infection or drug use. Signs and symptoms of LSCD include conjunctivalization, corneal vascularisation, pain, tear, redness, oedema, poor vision and blindness, which are thought to be associated with failure of epithelial regeneration. Similar symptoms and a delayed wound healing response could be reproduced in rabbits by surgically removing the limbus. The degree of loss of limbal tissue has been shown to correlate with the severity of pathology. The LSCD may result from the destruction of the supporting SC niche, as occurs in hereditary diseases like aniridia or acquired disorders which lead to chronic inflammation of the limbus. However, the more common etiology is related to external factors that destroy the limbal SCssuch as Stevens-Johnson syndrome (SJS) and chemical or thermal burns. Patients suffering from LSCD may present with a wide variety of symptoms related to poor epithelial wound healing and recurrent erosions. Patients often experience chronic conjunctival redness, decreased vision, photophobia, foreign body sensation, tearing, blepharospasm, and recurrent episodes of pain from recurrent epithelial breakdown. The pain, photophobia, and discomfort are often debilitating. However, most of these symptoms are nonspecific and inadequate to make the diagnosis correctly. LSCD can be detected clinically based on the clinical presentation described above. However, some of the signs present in LSCD are also seen in other conditions that do not have a component of LSCD. In particular, signs in partial LSCD are often subtle and non-specific. Laboratory tests are necessary to confirm the diagnosis of LSCD and monitor success of surgical interventions. In this section, impression cytology and in vivo confocal microscopy are discussed. Accurate diagnosis of LSCD is the first step in managing patients presenting with LSCD. In all cases, time and effort should be taken first to optimize the ocular surface by controlling causative factors and comorbid conditions. This includes treatment of autoimmune diseases and chronic ocular inflammation by immunosuppression and/or topical steroids, and the eradication of an infection or iatrogenic insult. Therapeutic options for LSCD range from conservative to invasive and depend on the severity of the pathology. Conservative therapeutic options include supportive management, corneal scraping, and amniotic membrane patching. In these cases, recovery depends on the presence of some remaining LESCs that can be rehabilitated to restore the epithelium. If there are no remaining stem cell reserves, the cornea must be reseeded with new LESCs.

“Limbal Stem Cell Deficiency- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Limbal Stem Cell Deficiency pipeline landscape is provided which includes the disease overview and Limbal Stem Cell Deficiency treatment guidelines. The assessment part of the report embraces, in depth Limbal Stem Cell Deficiency 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, Limbal Stem Cell Deficiency 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 Limbal Stem Cell Deficiency R&D. The therapies under development are focused on novel approaches to treat/improve Limbal Stem Cell Deficiency.

Limbal Stem Cell Deficiency Emerging Drugs Chapters

This segment of the Limbal Stem Cell Deficiency 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.

Limbal Stem Cell Deficiency Emerging Drugs

LSC 2: RHEACELLLSC 2, is an investigational drug being developed by Rheacell. LSC 2, belongs to the class of stem cell therapy. The allogeneic investigational product LSC2 contains ABCB5-positive limbal stem cells (from corneal rims of cadaveric donors, expanded ex vivo, isolated and stored in a donor cell bank). Currently, the drug is being developed in Phase I/II stage of Clinical trial evaluation for the treatment of Limbal stem cell deficiency.

KPI 012: Kala Pharmaceuticals Kala Pharmaceuticals lead clinical-stage candidate is KPI-012, a topically dosed ophthalmic therapy developed from the MSC-S platform. KPI-012 contains multiple classes of proteins relevant to ocular surface tissue repair, including matrix proteins, growth factors, neurotrophic factors and protease inhibitors. Kala Pharmaceuticals believe that the presence of these factors enables KPI-012 to provide a multifactorial mechanism of action that is relevant to the treatment of multiple rare ocular surface diseases. In addition to PCED, Kala Pharmaceuticals are planning to advance KPI-012 for the treatment of partial limbal stem cell deficiency and ocular manifestations of moderate-to-severe Sjögren's. Patients with Partial LSCD could be appropriate candidates for a cell-free regenerative therapy such as KPI-012, which acts to maintain the integrity of the ocular surface and avoid the vision impairment and pain associated with LSCD. Currently, the drug is in Preclinical stage of development for the treatment of partial Limbal stem cell deficiency.

Research programme: regenerative therapeutics: Surrozen Research programme: regenerative therapeutics, is an investigational programme being developed by Surrozen. Currently the programme is being studied in Discovery stage of development for the treatment of Limbal stem celldeficiency.

Limbal Stem Cell Deficiency Therapeutic Assessment

This segment of the report provides insights about the different Limbal Stem Cell Deficiency drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Limbal Stem Cell Deficiency

There are approx. 5+ key companies which are developing the therapies for Limbal Stem Cell Deficiency. The companies which have their Limbal Stem Cell Deficiency drug candidates in the most advanced stage, i.e. phase I/II include, RHEACELL.

Phases

This report covers around 5+ 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

Limbal Stem Cell Deficiency 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.

Limbal Stem Cell Deficiency Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Limbal Stem Cell Deficiency 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 Limbal Stem Cell Deficiency drugs.

Limbal Stem Cell Deficiency Report Insights

• Limbal Stem Cell Deficiency Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Limbal Stem Cell Deficiency 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 Limbal Stem Cell Deficiency drugs?
• How many Limbal Stem Cell Deficiency drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Limbal Stem Cell Deficiency?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Limbal Stem Cell Deficiency 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 Limbal Stem Cell Deficiency and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• RHEACELL
• Kala Pharmaceuticals
• Surrozen

Key Products

• LSC 2
• KPI 012

Research programme: regenerative therapeutics


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