Keratoconus - Pipeline Insight, 2024

This “Keratoconus - Pipeline Insight, 2024” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Keratoconus 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

Keratoconus: Understanding

Keratoconus: Overview

Keratoconus is an eye (ocular) disorder characterized by progressive thinning and changes in the shape of the cornea. The cornea is the thin, clear outer layer of the eye and is normally dome-shaped. Slowly progressive thinning of the cornea causes a cone-shaped bulge to develop towards the center of the cornea in the areas of greatest thinning. Affected individuals develop blurry or distorted vision, sensitivity to light (photophobia), and additional vision problems. Keratoconus often begins at puberty and most often is seen in teenagers or young adults. The specific underlying cause is not fully understood and most likely the condition results from the interaction of multiple factors including genetic and environmental ones.

The corneas in both eyes are usually affected (bilateral), although the progression and severity of the condition in each eye may differ (asymmetric development), which means one eye may be notably worse than the other. Symptoms usually become apparent during adolescence or young adulthood (i.e. late teens through early 20s). Keratoconus may become progressively worse for 10 to 20 years before slowing. Older adults typically do not have worsening of keratoconus. Because of the progressive nature of the disorder, affected individuals may have to change glasses frequently.

Keratoconus may be diagnosed based upon a complete patient and family history and thorough eye examination. Such an examination may include evaluation of the external appearance of the eyes, visual acuity, eye movements, and visual fields; the use of a special, illuminated microscope that allows physicians to view the eye through high magnification (slit-lamp examination); and/or additional tests or procedures.

The treatment of keratoconus is based upon the severity of the condition in the individual and the rate of progression of the disorder. In some individuals with mild symptoms, vision may be improved with the use of appropriate eyeglasses or soft contact lenses. However, progressive changes in vision often necessitate frequent prescription changes.

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

Keratoconus Emerging Drugs Chapters

This segment of the Keratoconus 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.

Keratoconus Emerging Drugs

EpiSmart: Epion Therapeutics, Inc.

Epion has developed a drug, drug delivery device that fully optimize cross-linking and allow for the minimally-invasive treatment for corneal ectasias, including keratoconus. Unlike current treatments for keratoconus, EpiSmart is designed to be implemented upon initial diagnosis and can prevent disease progression. Epion’s elegant approach elevates the current standard of care for keratoconus by enabling the treatment of both eyes simultaneously and eliminating the need for further deterioration. EpiSmart is an investigational drug-device combination product. EpiSmart and its components (Epiprep, Ribostat, and UVA Device) are not yet approved by the Food and Drug administration or by other regulatory bodies. Currently, the drug is in Phase III stage of its development for the treatment of Keratoconus.

IVMED-80: iVeena Delivery Systems

IVMED-80 is a proprietary non-surgical, non-invasive, disease modifying intervention with FDA orphan designation that upregulates lysyl oxidase (LOX) and induces corneal crosslinking pharmacologically. Upon issuance, the patent will provide US protection until at least 2041. The patent will protect key compositions and formulations of IVMED-80. In November 2020, the drug candidate received a $1.68 M in Federal government grants for its keratoconus developmental program. Currently the drug is in Phase II stage of development for the treatment of Keratoconus.

Keratoconus: Therapeutic Assessment

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

Major Players in Keratoconus

• There are approx. 3+ key companies which are developing the therapies for Keratoconus. The companies which have their Keratoconus drug candidates in the most advanced stage, i.e. phase III include, Epion Therapeutics, Inc.

Phases

This 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

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
• 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.

Keratoconus: Pipeline Development Activities

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

Keratoconus Report Insights

• Keratoconus Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Epion Therapeutics, Inc.
• iVeena Delivery Systems

Key Products

• EpiSmart
• IVMED-80

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