Keratoconus Pipeline 2026: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Keratoconus pipeline constitutes 3+ key companies continuously working towards developing 3+ Keratoconus treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Keratoconus Pipeline Insight, 2026" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Keratoconus Market.

The Keratoconus Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Keratoconus Pipeline Report: https://www.delveinsight.com/sample-request/keratoconus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Keratoconus treatment therapies with a considerable amount of success over the years.
• Keratoconus companies working in the treatment market are Glaukos Corporation, iVeena Delivery Systems, Ocular Therapeutix, Inc., and others, are developing therapies for the Keratoconus treatment
• Emerging Keratoconus therapies in the different phases of clinical trials are- Riboflavin 5'-Phosphate, IVMED-80, Dextenza, and others are expected to have a significant impact on the Keratoconus market in the coming years.
• In October 2025, Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company specializing in innovative treatments for glaucoma, corneal conditions, and retinal disorders, announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for EpioxaTM HD / EpioxaTM ("Epioxa"). Epioxa represents a significant advancement in corneal cross-linking therapy for keratoconus, a rare and potentially vision-threatening disorder that frequently remains underdiagnosed and undertreated.
• In February 2025, Glaukos Corporation announced that the FDA has accepted its New Drug Application (NDA) for Epioxa, an innovative non-invasive, epithelium-on (Epi-on) corneal cross-linking therapy for progressive keratoconus. The PDUFA target date for a regulatory decision is October 2025. If approved, Epioxa would be the first FDA-approved Epi-on therapy, providing a less invasive alternative to existing cross-linking methods.
• In December 2024, Glaukos Corporation (NYSE: GKOS), a pharmaceutical and medical technology company specializing in innovative treatments for glaucoma, corneal disorders, and retinal diseases, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for EpioxaTM (Epi-on). This next-generation corneal cross-linking iLink therapy is designed for the treatment of keratoconus, a progressive and sight-threatening corneal disease.

Keratoconus Overview
Keratoconus is a progressive eye disease in which the normally round, dome-shaped cornea thins and begins to bulge into a cone-like shape. This cone shape deflects light as it enters the eye, causing distorted vision.

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Emerging Keratoconus Drugs Under Different Phases of Clinical Development Include:
• Riboflavin 5'-Phosphate: Glaukos Corporation
• IVMED-80: iVeena Delivery Systems
• Dextenza: Ocular Therapeutix, Inc.

Keratoconus Route of Administration
Keratoconus 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
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Keratoconus Molecule Type
Keratoconus Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Keratoconus Pipeline Therapeutics Assessment
• Keratoconus Assessment by Product Type
• Keratoconus By Stage and Product Type
• Keratoconus Assessment by Route of Administration
• Keratoconus By Stage and Route of Administration
• Keratoconus Assessment by Molecule Type
• Keratoconus by Stage and Molecule Type

DelveInsight's Keratoconus Report covers around 3v+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Keratoconus product details are provided in the report. Download the Keratoconus pipeline report to learn more about the emerging Keratoconus therapies
https://www.delveinsight.com/sample-request/keratoconus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Keratoconus Therapeutics Market include:
Key companies developing therapies for Keratoconus are - CooperVision, Optik Seis, SAFILENS S.R.L, Novartis AG, CIBA VISION, Menicon Co. Ltd, Bausch & Lomb Incorporated, Johnson & Johnson Vision Care Inc, HOYA Vision Care, and others.

Keratoconus Pipeline Analysis:
The Keratoconus pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Keratoconus with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Keratoconus Treatment.
• Keratoconus key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Keratoconus Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Keratoconus market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Keratoconus drugs and therapies
https://www.delveinsight.com/sample-request/keratoconus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Keratoconus Pipeline Market Drivers
• Increasing Disease Awareness and Early Diagnosis: Greater adoption of corneal topography and tomography technologies is enabling earlier detection, expanding the addressable patient population.
• Rising Demand for Minimally Invasive Treatments: Growing preference for non-surgical or less invasive interventions, such as advanced corneal cross-linking techniques, is fueling pipeline innovation.
• Technological Advancements in Ophthalmology: Improvements in diagnostic imaging, customized contact lenses, and bioengineered corneal implants are encouraging R&D activity.
• Expanding Clinical Research and Investment: Increased funding from biotech firms and ophthalmology-focused companies is accelerating the development of novel pharmacologic and regenerative therapies.
• Unmet Need for Disease-Modifying Therapies: Current treatments mainly slow progression rather than reverse corneal thinning, creating opportunities for breakthrough therapeutics.

Keratoconus Pipeline Market Barriers
• Limited Patient Pool in Advanced Stages: As a relatively uncommon progressive disorder, patient numbers eligible for advanced interventional therapies remain moderate.
• High Development and Regulatory Costs: Ophthalmic device and drug development requires extensive clinical validation, increasing time and financial investment.
• Dependence on Surgical and Device-Based Standards: Established procedures like corneal transplantation and cross-linking limit rapid adoption of new pipeline therapies.
• Reimbursement and Pricing Constraints: Coverage limitations for elective or device-based procedures may restrict commercial uptake.
• Clinical Trial Recruitment Challenges: Variability in disease progression and staging complicates patient selection and endpoint standardization.

Scope of Keratoconus Pipeline Drug Insight
• Coverage: Global
• Key Keratoconus Companies: Glaukos Corporation, iVeena Delivery Systems, Ocular Therapeutix, Inc., and others
• Key Keratoconus Therapies: Riboflavin 5'-Phosphate, IVMED-80, Dextenza, and others
• Keratoconus Therapeutic Assessment: Keratoconus current marketed and Keratoconus emerging therapies
• Keratoconus Market Dynamics: Keratoconus market drivers and Keratoconus market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

This release was published on openPR.