ALISO VIEJO, Calif. - Glaukos Corporation (NYSE: NYSE:GKOS), an ophthalmic medical technology company, reported successful results from its second Phase 3 confirmatory trial for Epioxa, a non-invasive drug therapy designed for keratoconus treatment. The trial met its primary efficacy endpoint, demonstrating significant improvement in corneal curvature compared to a control group at the 12-month mark.
The study, involving 312 eyes, showed a statistically significant change in maximum corneal curvature (Kmax), a key indicator of disease progression in keratoconus patients. The Epioxa treatment group exhibited a mean Kmax improvement of 1.0 diopter, fulfilling the U.S. FDA's efficacy criteria for keratoconus trials.
Epioxa, which aims to halt or reduce keratoconus progression, was well-tolerated, with a high completion rate among participants. No serious adverse events were reported, and no treatment-related systemic effects were observed. The favorable safety profile and efficacy data are expected to support Glaukos' New Drug Application (NDA) submission to the FDA by the end of 2024.
This trial, along with the first Phase 3 pivotal trial, forms the basis for the NDA submission. Both studies have shown Epioxa's potential as the first FDA-approved, non-invasive treatment option for keratoconus, offering benefits such as reduced procedure time and improved patient comfort.
Keratoconus, often diagnosed in adolescence, leads to corneal thinning and can result in severe vision loss or the need for a corneal transplant if untreated. Current treatments manage symptoms, but Glaukos' iLink therapy, including the FDA-approved Photrexa, has been shown to slow or halt disease progression.
Glaukos continues to innovate in ophthalmic treatments, already having launched products for glaucoma and developing a pipeline of technologies for chronic eye diseases. The company's pursuit of a non-invasive therapy for keratoconus represents its commitment to addressing unmet needs in eye care.
This news is based on a press release statement from Glaukos Corporation.
In other recent news, Glaukos Corporation has reported a significant 19% increase in consolidated net sales for the second quarter, reaching $95.7 million. This robust performance led the company to revise its full-year 2024 net sales guidance upwards to between $370 and $376 million. The growth was primarily attributed to the success of its US interventional glaucoma franchises, including the iStent portfolio and iDose TR.
In line with this, Glaukos announced the redemption of its outstanding 2.75% Convertible Senior Notes due 2027, with a principal amount of $57.5 million, as part of the company's financial management strategy. Analyst firms BTIG and Stifel have both maintained a positive outlook on Glaukos. BTIG reaffirmed its Buy rating with a steady price target of $139.00, while Stifel raised its price target to $145 from $130 based on a survey of iDose-trained surgeons.
Furthermore, the company continues to invest in novel technologies, including Epioxa, and expects the adoption of iDose TR to grow in future quarters, facilitated by the J-code, which ensures consistent reimbursement. These recent developments highlight Glaukos Corporation's ongoing efforts to innovate and expand its market presence.
InvestingPro Insights
Glaukos Corporation's recent success with its Epioxa trial aligns with several key financial metrics and insights from InvestingPro. The company's market capitalization stands at $7.06 billion, reflecting investor confidence in its innovative ophthalmic technologies.
InvestingPro data shows that Glaukos has experienced significant growth, with a remarkable 90.41% price total return over the past year. This performance is consistent with the positive clinical trial results and the company's potential to introduce a groundbreaking treatment for keratoconus. The stock is currently trading near its 52-week high, with the price at 94.59% of its peak, indicating strong market optimism about the company's prospects.
Despite the promising trial results, it's important to note that Glaukos is not currently profitable. An InvestingPro Tip reveals that analysts do not anticipate the company will be profitable this year. This is not uncommon for biotech companies investing heavily in research and development, as Glaukos is doing with Epioxa and other pipeline products.
Another InvestingPro Tip highlights that Glaukos operates with a moderate level of debt, which may provide financial flexibility as it moves towards potential FDA approval and commercialization of Epioxa. The company's liquid assets exceeding short-term obligations further supports its ability to fund ongoing research and potential product launches.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips that could provide deeper insights into Glaukos's financial health and market position.
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