Glaukos' Epioxa Achieves Positive Phase 3 Results for Keratoconus Treatment

Glaukos Corporation announced that the second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on) met its pre-specified primary efficacy endpoint. This next-generation corneal cross-linking iLink therapy demonstrated a statistically significant and clinically relevant improvement in maximum corneal curvature (Kmax) at 12 months from baseline compared to the sham/placebo-controlled arm. Kmax is an FDA-accepted primary efficacy outcome for keratoconus pivotal trials, measuring the steepest corneal curvature and indicating disease progression.

Publish Date: 16-10-2024 Source: Glaukos Corporation

Keratoconus is a bilateral and asymmetric cornea disease characterized by progressive thinning, steepening, irregular astigmatism, and decreased visual acuity. Environmental and familial factors are associated with an increased risk of developing the condition. Eye rubbing is also a strong risk factor in the pathogenesis of keratoconus. Classification systems based on morphological changes and disease evolution are Morphological (Buxton), Keratometric, Hom’s, and Amsler-Krumeich. The condition typically develops in the second and third decades of life and progresses until the fourth decade, when it stabilizes. It can also develop earlier or later in life. The condition typically affects both eyes, although with different degrees of severity. While there is no clear consensus on the signs and symptoms associated with early keratoconus, subclinical or form-fruste keratocon us is commonly used to describe the early stages of the disease.

Worldwide occurrence of keratoconus, with prevalence estimates ranging from 0.2 to 4,790 per 100,000 individuals. The age group with the highest prevalence and incidence is typically between 20 and 30.

However, the current Keratoconus treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (IVMED-80, Riboflavin, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Keratoconus treatment. The key companies in the advanced development stage are iVeena Delivery Systems, Inc., Price Vision Group, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Keratoconus to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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