Neurotrophic Keratitis - Pipeline Insight, 2025

DelveInsight's, "Neurotrophic Keratitis - Pipeline Insight, 2025" report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Neurotrophic Keratitis 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 Keratitis: Understanding

Neurotrophic Keratitis: Overview

Neurotrophic keratitis is a rare, progressive, and vision-threatening corneal disease caused by impaired sensory innervation, most commonly affecting the trigeminal nerve. Characterized by decreased or absent corneal sensation, it leads to poor epithelial healing, persistent epithelial defects (PEDs), ulceration, stromal melting, and potentially perforation. It typically follows a three-stage progression (Mackie classification) and often presents with minimal symptoms despite significant corneal damage. Diagnosis relies on clinical evaluation, corneal sensation testing, and imaging techniques like AS-OCT or in vivo confocal microscopy. Management is tailored to disease severity and includes lubrication, autologous serum, therapeutic contact lenses, and biologic treatments such as recombinant nerve growth factor (cenegermin). Advanced or refractory cases may require surgical interventions like amniotic membrane transplantation, tarsorrhaphy, or corneal neurotization. Early diagnosis and a multidisciplinary approach are essential to preserve vision and prevent irreversible corneal damage.

Neurotrophic keratitis presents with a range of ocular signs and symptoms that reflect progressive corneal damage due to impaired sensory innervation. Common features include blurred vision from corneal edema, scarring, or irregular epithelium; mild redness due to reduced inflammatory response; and photophobia in some cases. Dry eye symptoms are frequent, stemming from tear film instability and reduced reflex tearing. A key hallmark is decreased or absent corneal sensation, often making early stages asymptomatic despite ongoing damage. Recurrent or persistent epithelial defects (PEDs), poor corneal wound healing, and eventual complications such as corneal scarring, ulcers, stromal melting, or perforation can develop, leading to significant vision loss if not promptly managed.

Corneal nerves play a critical role in maintaining the structural and functional integrity of the corneal epithelium by supporting epithelial cell proliferation, metabolism, and wound healing. In neurotrophic keratitis, damage to these sensory nerves disrupts neuromodulator signaling, leading to reduced epithelial cell vitality, impaired mitosis, and compromised repair mechanisms. Additionally, loss of sensory input diminishes the lacrimation reflex, worsening ocular surface desiccation. Morphological changes such as decreased epithelial thickness, intracellular swelling, microvilli loss, and abnormal basal lamina formation are commonly observed. These alterations contribute to the development of persistent epithelial defects, which may progress to ulceration, stromal melting, or perforation. Several chemical mediators-including nerve growth factor (NGF), substance P, neuropeptide Y, and calcitonin gene-related peptide-are implicated in the disease's pathogenesis, highlighting the complex neurochemical basis of corneal degeneration in neurotrophic keratitis.

Treatment and management of neurotrophic keratitis are tailored to disease severity and focus on promoting corneal healing, protecting the ocular surface, and restoring nerve function. Early stages are managed with preservative-free artificial tears, punctal occlusion, and autologous serum or platelet-rich plasma drops to support epithelial repair. Recombinant nerve growth factor (cenegermin) is a key pharmacologic advancement shown to stimulate corneal nerve regeneration. In moderate to severe cases, protective therapies such as amniotic membrane transplantation, therapeutic contact lenses, and tarsorrhaphy are often required. Advanced or refractory cases may necessitate surgical interventions like corneal neurotization or keratoplasty. An interprofessional approach is essential for optimal outcomes, with early diagnosis and stage-specific therapies significantly improving prognosis and preserving vision.

"Neurotrophic Keratitis- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Neurotrophic Keratitis pipeline landscape is provided which includes the disease overview and Neurotrophic Keratitis treatment guidelines. The assessment part of the report embraces, in depth Neurotrophic Keratitis 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 Keratitis 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 Keratitis R&D. The therapies under development are focused on novel approaches to treat/improve Neurotrophic Keratitis.

Neurotrophic Keratitis Emerging Drugs Chapters

This segment of the Neurotrophic Keratitis report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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 Keratitis Emerging Drugs

• BRM424: BRIM Biotechnology Inc.

BRM424 is an investigational regenerative peptide developed by BRIM Biotechnology for the treatment of neurotrophic keratitis (NK). The peptide, derived from Pigment Epithelium-Derived Factor (PEDF), functions by stimulating the proliferation and differentiation of corneal limbal stem cells, thereby promoting the regeneration of the corneal epithelium and enhancing wound healing. In preclinical studies, BRM424 has demonstrated efficacy in accelerating corneal repair and restoring sensory function. The US Food and Drug Administration (FDA) has also granted BRM424 Orphan Drug Designation for NK in December 2022. Currently, the drug is in Phase II stage of its development for the treatment of Neurotrophic Keratitis.

• STSP-0902: Staidson (Beijing) Biopharmaceuticals Co., Ltd

STSP-0902 is an investigational ophthalmic solution developed by Staidson (Beijing) Biopharmaceuticals Co., Ltd. It is a recombinant human nerve growth factor (NGF) fusion protein designed to activate the TrkA receptor pathway, which plays a crucial role in nerve growth and repair. Preclinical studies have demonstrated that STSP-0902 can promote corneal nerve regeneration, enhance corneal integrity, and improve corneal sensory sensitivity in models of neurotrophic keratitis. Additionally, STSP-0902 has shown potential to reduce pain responses associated with NGF therapies. Currently, the drug is in Phase I stage of its development for the treatment of Neurotrophic Keratitis.

Neurotrophic Keratitis: Therapeutic Assessment

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

• Major Players in Neurotrophic Keratitis
• There are approx. 3+ key companies which are developing the therapies for Neurotrophic Keratitis. The companies which have their Neurotrophic Keratitis drug candidates in the most advanced stage, i.e. Phase II include, BRIM Biotechnology Inc.
• Phases

DelveInsight's report covers around 3+ 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 Keratitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Neurotrophic Keratitis: Pipeline Development Activities

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

Neurotrophic Keratitis Report Insights

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

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

Key Players

• BRIM Biotechnology Inc.
• Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Recordati Rare Diseases
• Claris Biotherapeutics, Inc.

Key Products

• BRM424
• STSP-0902
• Udonitrectag
• CSB-001