Glaukos Stock Down Despite NDA Submission of Epioxa to the FDA

Glaukos Corporation GKOS recently announced that it has submitted its New Drug Application (NDA) to the FDA for Epioxa. Epioxa is GKOS’ next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a progressive, sight-threatening corneal disease.The NDA submission includes data from two Phase 3 pivotal trials of Epioxa, which successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.Likely Trend of GKOS Stock Following the NewsFollowing the announcement, shares of the company moved 1.7% south to $148.36 on Monday. In the past year, GKOS’s shares have gained 80.2% compared with the industry’s growth of 4.5%. The S&P 500 has gained 26.6% in the same time frame.However, the submission of the NDA for Epioxa to the FDA could positively impact Glaukos' stock price by boosting investor confidence. If approved, Epioxa would offer a first-of-its-kind non-invasive treatment for keratoconus, which is likely to attract strong demand and market share. The positive Phase 3 trial results further strengthen the company's growth outlook, making the stock more appealing to investors anticipating future revenue growth.Meanwhile, GKOS currently has a market capitalization of $8.32 billion. The Zacks Consensus Estimate for fiscal 2024 revenues is pegged at $378.7 million, indicating 20.3% growth from the reported fiscal 2023.Image Source: Zacks Investment ResearchMore on the GKOS’ Epioxa & iLink TherapyKeratoconus is a severe eye condition typically identified in adolescence characterized by progressive corneal thinning and weakness. It is one of the main reasons for corneal transplants performed in the United States. If left untreated, Keratoconus can lead to loss of vision. Glaukos’ first-generation iLink therapy, known as Photrexa or Epi-off, is the first and only FDA-approved therapy shown to slow or halt disease progression.Epioxa is a novel therapy designed to preserve the corneal epithelium, reduce procedure time, and improve patient comfort while shortening recovery. It uses a unique drug formulation to penetrate the corneal epithelial layer, combined with stronger UV-A irradiation and supplemental oxygen to enhance cross-linking. If approved, Epioxa will be the first non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium.The corneal cross-linking iLink therapies from Glaukos use proprietary, bio-activated drug formulations to strengthen corneal tissue and stop the progression of keratoconus. In October, GKOS announced that the second Phase 3 confirmatory pivotal trial for Epioxa, the company’s next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, successfully met the study’s pre-specified primary efficacy endpoint. The results demonstrated a clinically relevant and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months from baseline between the Epioxa-treated arm and sham/placebo-controlled arm. GKOS’ Favorable Industry ProspectsPer a report by Market Research Future, 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%. Rising exposure to sun and UV rays are the prime market drivers helping the market grow.GKOS’s Zacks Rank & Other Stocks to ConsiderGKOS carries a Zacks Rank #2 (Buy) at present.Some other top-ranked stocks in the broader medical space are Masimo MASI, Accuray ARAY and Abbott Laboratories ABT.Masimo, sporting a Zacks Rank #2 at present, has an estimated growth rate of 11.8% for 2025. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.MASI’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 17.10%. Its shares have risen 31.7% against the industry’s 1% decline in the past six months.Accuray, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1200% for 2025. Its earnings missed estimates in three of the trailing four quarters and met in one, delivering an average negative surprise of 141.97%.ARAY’s shares have gained 8.8% against the industry’s 1% decline in the past six months.Abbott, carrying a Zacks Rank of 2 at present, has an estimated earnings growth rate of 10% for 2025. It delivered a trailing four-quarter average earnings surprise of 1.64%.ABT’s shares have risen 8.5% in the past six months compared with the industry’s 7.2% growth.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT): Free Stock Analysis Report Accuray Incorporated (ARAY): Free Stock Analysis Report Masimo Corporation (MASI): Free Stock Analysis Report Glaukos Corporation (GKOS): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks