Glaukos Stock Down Despite NDA Submission of Epioxa to the FDA

Glaukos Corporation (GKOS) and Epioxa - Glaukos Corporation submitted a New Drug Application (NDA) to the FDA for Epioxa, its next-generation corneal cross-linking iLink therapy for treating keratoconus [13] - Epioxa is a novel therapy designed to preserve the corneal epithelium, reduce procedure time, improve patient comfort, and shorten recovery [8] - If approved, Epioxa will be the first non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium [9] - The NDA submission includes data from two Phase 3 pivotal trials, which successfully achieved pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles [1] - The second Phase 3 confirmatory pivotal trial for Epioxa showed a clinically relevant and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months from baseline [10] Market and Industry Prospects - The global keratoconus treatment market was valued at $0.31 billion in 2023 and is anticipated to reach$0.41 billion by 2032 at a CAGR of 3.7% [18] - Rising exposure to sun and UV rays are the prime market drivers for the keratoconus treatment market [18] - Glaukos' first-generation iLink therapy, Photrexa or Epi-off, is the first and only FDA-approved therapy shown to slow or halt keratoconus progression [2] Financial Performance and Stock Trends - Glaukos currently has a market capitalization of $8.32 billion [16] - The Zacks Consensus Estimate for fiscal 2024 revenues is pegged at$378.7 million, indicating 20.3% growth from fiscal 2023 [16] - GKOS shares have gained 80.2% in the past year compared to the industry's growth of 4.5% and the S&P 500's gain of 26.6% [14] - Following the NDA submission announcement, GKOS shares moved 1.7% lower to $148.36 [14] Competitor Analysis - Accuray (ARAY) has an estimated growth rate of 1200% for 2025 but missed earnings estimates in three of the trailing four quarters with an average negative surprise of 141.97% [4] - ARAY shares have gained 8.8% in the past six months against the industry's 1% decline [5] - Abbott Laboratories (ABT) has an estimated earnings growth rate of 10% for 2025 and delivered a trailing four-quarter average earnings surprise of 1.64% [21] - ABT shares have risen 8.5% in the past six months compared to the industry's 7.2% growth [6] - Masimo (MASI) has an estimated growth rate of 11.8% for 2025 and surpassed earnings estimates in each of the trailing four quarters with an average surprise of 17.10% [12][20] - MASI shares have risen 31.7% against the industry's 1% decline in the past six months [20]