FDA sets review date for Glaukos’ keratoconus drug

ALISO VIEJO, Calif. - The U.S. Food and Drug Administration (FDA) has acknowledged the New Drug Application (NDA) from Glaukos Corporation (NYSE: NYSE:GKOS), an ophthalmic medical technology and pharmaceutical company, for their drug Epioxa™ (Epi-on). The announcement comes as Glaukos shares, currently trading at $125.88, have experienced a significant 17.8% decline over the past week, though maintaining a strong 40.5% gain over the last year. According to InvestingPro analysis, the stock’s RSI suggests oversold conditions, potentially presenting an interesting entry point for investors following the recent pullback. This therapy is designed for the treatment of keratoconus, a condition that can lead to severe vision impairment. The FDA has set the Prescription Drug User Fee Act (PDUFA) goal date for October 20, 2025, to complete its review of Epioxa.

The company’s chairman and CEO, Thomas Burns, expressed optimism about the potential benefits of Epioxa for keratoconus patients. He highlighted that Epioxa aims to reduce procedure times, improve patient comfort, and shorten recovery time compared to current treatments. The company’s strong financial position, with a current ratio of 5.99 and moderate debt levels, suggests it has ample resources to support the product launch. Glaukos has demonstrated impressive revenue growth of 21.85% over the last twelve months, with a robust gross profit margin of 75.48%. The NDA submission for Epioxa includes positive results from two Phase 3 pivotal trials, which met primary efficacy endpoints and demonstrated a favorable safety and tolerability profile.

Glaukos’ iLink therapies, including Epioxa, involve proprietary drug formulations that strengthen corneal tissue and prevent the progression of keratoconus. This disease typically manifests during teenage years, leading to the thinning and weakening of the cornea. Without treatment, keratoconus can result in vision loss or necessitate a corneal transplant. Glaukos’ existing FDA-approved iLink therapy, Photrexa® (Epi-off), has been shown to slow or halt the disease progression.

Epioxa utilizes a novel drug formulation intended to penetrate the corneal epithelium, combined with a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require the removal of the corneal epithelium.

This news is based on a press release statement from Glaukos Corporation. The company has a history of innovation in ophthalmic treatments, including the development of Micro-Invasive Glaucoma Surgery (MIGS) and the commercialization of iDose® TR, an extended-release intracameral drug therapy for glaucoma. Glaukos aims to continue advancing treatments for chronic eye diseases with their pipeline of novel technologies. Three analysts have recently revised their earnings estimates upward for the upcoming period, reflecting growing confidence in the company’s prospects. For deeper insights into Glaukos’s financial health and growth potential, including 9 additional exclusive ProTips and comprehensive valuation analysis, visit InvestingPro.

In other recent news, Glaukos Corporation reported its fourth-quarter 2024 earnings with revenue reaching $105.5 million, marking a 28% increase from the previous year and surpassing forecasts of $100.53 million. However, the company reported an earnings per share (EPS) of -$0.40, slightly missing the expected -$0.38. Truist Securities maintained a Buy rating on Glaukos with a price target of $185, citing the potential of the iDose product, which saw revenue grow from $13 million to $16 million quarter-over-quarter. Meanwhile, BTIG adjusted its price target for Glaukos to $155 from $157, maintaining a Buy rating, after noting the company’s strong glaucoma revenue growth, which reached $84.1 million, a 38.9% increase year-over-year.

Despite the positive revenue figures, Glaukos faced challenges with its Corneal Health revenue, which fell short of estimates, coming in at $21.4 million. The company has provided a fiscal year 2025 guidance range of $475 million to $485 million, representing a growth of 24% to 26%. Analysts from BTIG highlighted that iDose is expected to play a larger role in supporting Glaukos’ growth, with projections for iDose revenue in fiscal year 2025 increased to approximately $117 million. Glaukos ended 2024 with no debt and $324 million in cash and equivalents, positioning itself for future expansion.

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