Glaukos Corp Stock Price, News & Analysis

Glaukos (NYSE: GKOS) announced FDA acceptance of its New Drug Application (NDA) for Epioxa™, a next-generation corneal cross-linking therapy for keratoconus treatment. The FDA set a PDUFA date of October 20, 2025, reflecting a standard 10-month review period.

Epioxa is designed as the first FDA-approved, non-invasive corneal cross-linking therapy that doesn't require corneal epithelium removal. The therapy aims to reduce procedure times, improve patient comfort, and shorten recovery time. The NDA submission includes data from two successful Phase 3 pivotal trials showing favorable efficacy, tolerability, and safety profiles.

Keratoconus, typically diagnosed in teenage years, affects approximately 90% of cases bilaterally, with up to 20% of patients requiring corneal transplant. Unlike conventional treatments that only address symptoms, Epioxa uses a proprietary drug formulation with UV-A irradiation and supplemental oxygen to strengthen corneal tissue and halt disease progression.

Glaukos (NYSE: GKOS) reported strong financial results for Q4 and full year 2024. The company achieved record Q4 net sales of $105.5 million, up 28% year-over-year, with glaucoma sales reaching $84.1 million, a 39% increase. Full-year 2024 net sales grew 22% to $383.5 million.

Q4 gross margin was 73% (82% non-GAAP), while operating loss improved to $28.7 million from $38.6 million in Q4 2023. The company reported a Q4 net loss of $33.6 million ($0.60 per share). For the full year 2024, net loss was $146.4 million ($2.77 per share).

Looking ahead, Glaukos provided 2025 net sales guidance of $475-485 million. The company maintains a strong financial position with approximately $324 million in cash and investments, with no debt.

Glaukos (NYSE: GKOS), a company specializing in ophthalmic pharmaceutical and medical technology for treating glaucoma, corneal disorders, and retinal diseases, has announced it will release its fourth quarter and full year 2024 financial results after market close on February 20, 2025.

The company has scheduled a conference call and simultaneous webcast for 1:30 p.m. PT (4:30 p.m. ET) on the same day to discuss the results. Investors can access the webcast through the company's investor relations website, while those wishing to participate in the conference call can dial 888-210-2212 (U.S.) or 646-960-0390 (International) using Conference ID 7935742.

Glaukos (NYSE: GKOS) announced positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform. In a 36-month follow-up analysis of Phase 3 trials, iDose TR demonstrated sustained IOP reductions with approximately 70% of subjects remaining well-controlled, compared to 58% of timolol control subjects.

The company has initiated a Phase 2b/3 clinical program for iDose TREX, its next-generation therapy with nearly twice the drug capacity. A 6-month Phase 4 study showed iDose TR combined with cataract surgery achieved a mean IOP reduction of 11.3 mmHg (44%) in open-angle glaucoma patients.

The iDose platform is designed to address patient non-adherence and side effects associated with topical medications by providing 24/7, long-duration efficacy with minimal side effects.

Glaukos (NYSE: GKOS) has submitted a New Drug Application (NDA) to the FDA for Epioxa™, a next-generation corneal cross-linking therapy for keratoconus treatment. The therapy is designed to be the first FDA-approved, non-invasive treatment that preserves the corneal epithelium. The NDA submission includes successful data from two Phase 3 pivotal trials showing favorable efficacy, tolerability, and safety profiles.

Epioxa features a proprietary drug formulation designed to penetrate the epithelium, utilizing stronger UV-A irradiation and supplemental oxygen to enhance cross-linking. The therapy aims to reduce procedure times, improve patient comfort, and shorten recovery time compared to conventional treatments. Keratoconus affects approximately 90% of cases bilaterally, with up to 20% of patients requiring corneal transplants if left untreated.

Glaukos (NYSE: GKOS), a company specializing in ophthalmic pharmaceutical and medical technology for glaucoma, corneal disorders and retinal diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for Tuesday, January 14, 2025, at 5:15 p.m. PT in San Francisco. A live and archived webcast will be accessible through the Investors section of the Glaukos website.

Glaukos (NYSE: GKOS), a company specializing in ophthalmic pharmaceutical and medical technology, has announced its participation in five major investor conferences in late 2024. The schedule includes appearances at the Stifel Healthcare Conference (Nov 19), Stephens Annual Investment Conference (Nov 20), BTIG Ophthalmology Day (Dec 2), Piper Sandler Annual Healthcare Conference (Dec 4), and Citi Global Healthcare Conference (Dec 5). Live and archived webcasts of these events will be accessible through the company's investor relations website.

Glaukos (NYSE: GKOS) reported strong Q3 2024 financial results with record net sales of $96.7 million, up 24% year-over-year. Glaucoma segment achieved record sales of $76.0 million (+30%), while Corneal Health sales reached $20.6 million (+5%). The company maintained a robust gross margin of 77% (82% non-GAAP) and raised its 2024 net sales guidance to $377-379 million. Despite revenue growth, Glaukos reported a net loss of $21.4 million ($0.39 per share), though improved from $30.4 million loss year-over-year. The company ended Q3 with approximately $267.2 million in cash and investments.

Glaukos (NYSE: GKOS) announced positive topline results from its Phase 3 confirmatory trial for Epioxa™, a next-generation corneal cross-linking therapy for keratoconus. The trial met its primary efficacy endpoint, demonstrating a clinically relevant and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months. Key findings include:

1. A Kmax treatment effect of –1.0 diopter (p <0.0001)
2. 91.5% of treated patients completed the 12-month trial
3. No treatment-related serious adverse events reported
4. No evidence of systemic effects or changes in corneal endothelial cell counts

Glaukos plans to submit a New Drug Application (NDA) to the FDA by the end of 2024. If approved, Epioxa could become the first FDA-approved, non-invasive drug therapy for keratoconus that preserves the corneal epithelium.