Neurotrophic Keratopathy - Pipeline Insight, 2024

This Neurotrophic Keratopathy - Pipeline Insight, 2024,” report provides comprehensive insights about 7+ companies and 7+ pipeline drugs in Neurotrophic Keratopathy 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

Neurotrophic Keratopathy Understanding

Neurotrophic Keratopathy: Overview

Neurotrophic keratitis is a degenerative corneal disease caused by impairment of corneal sensory innervation. It is characterized by decreased or absent corneal sensation, leading to epithelial breakdown, impairment of healing, and ultimately to the development of corneal ulceration, melting and perforation. Ocular and systemic conditions associated with damage at any level to the fifth cranial nerve, from the Trigeminal nucleus to the corneal nerve endings may lead to the development of neurotrophic keratitis. The most common causes include herpetic keratitis, chemical burns, long-term use of contact lenses, corneal surgery, ablative procedures for trigeminal neuralgia, and surgical procedures for reduction of jaw fractures. Other less frequent causes are space-occupying intracranial masses (e.g., schwannoma, meningioma and aneurysms) that can lead to compression of the nerve and reduce corneal sensitivity. Systemic diseases that may compromise trigeminal function like diabetes, multiple sclerosis and Leprosy may lead to the development of neurotrophic keratitis. Presence of neurotrophic keratitis in children is rare and may be seen in association with congenital syndromes like Riley-Day syndrome, Goldenhar- Gorlin syndrome, Mobius syndrome, Familial corneal hypesthesia and Congenital Insensitivity to Pain with Anhidrosis.

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

This segment of the Neurotrophic Keratopathy 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.

Neurotrophic Keratopathy Drugs
OC-01: Epizyme OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to activate natural tear film production. The human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film is responsible for forming the primary refracting surface of the eye, as well as protecting and moisturizing the cornea. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in this indication in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not beenestablished.

Neurotrophic Keratopathy: Therapeutic Assessment

This segment of the report provides insights about the Neurotrophic Keratopathy drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Neurotrophic Keratopathy

There are approx. 7+ key companies which are developing the therapies for Neurotrophic Keratopathy. The companies which have their Neurotrophic Keratopathy drug candidates in the most advanced stage, i.e. phase II include Oyster Point Pharma.

Phases

This report covers around 7+ 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

Neurotrophic Keratopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intranasal
• Intrathecal
• Intravenous
• Oral
• Oral/Intravenous
• Parenteral
• Subcutaneous
• Subcutaneous/Intramuscular
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Antisense oligonucleotide
• Gene therapy
• Hormones
• Neuropeptides
• Oligonucleotides
• Small Molecule
• Triglyceride

Product Type

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

Neurotrophic Keratopathy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Neurotrophic Keratopathy 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 Neurotrophic Keratopathy drugs.

Neurotrophic Keratopathy Report Insights

• Neurotrophic Keratopathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• RegeneRx Biopharmaceuticals
• RECORDATI
• Oyster Point Pharma
• Oculis
• Gtree Pharmaceuticals
• Dompé Farmaceutici
• Claris Biotherapeutics

Key Products

• RGN-259
• REC 0559
• OC-01
• OCS-05
• NRO-1
• GBT-201
• rhNGF
• CSB-001

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