ALISO VIEJO, Calif. - Glaukos Corporation (NYSE:GKOS), a company specializing in ophthalmic pharmaceuticals and medical technology with a market capitalization of $8.3 billion and impressive year-to-date returns of nearly 90%, announced today the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™, a novel treatment for keratoconus, a progressive eye disease.
The NDA for Epioxa, a next-generation corneal cross-linking iLink therapy, marks a significant step for Glaukos in its efforts to offer a non-invasive treatment option for patients with keratoconus. Unlike current treatments that require the removal of the corneal epithelium, Epioxa aims to provide a less invasive approach that could reduce procedure times, enhance patient comfort, and shorten recovery periods. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 5.54 and operates with a moderate debt level, supporting its ongoing research and development initiatives.
Thomas Burns, Glaukos chairman and CEO, expressed optimism about the potential of Epioxa, citing its design to improve the treatment paradigm for keratoconus sufferers. The submission includes positive data from two Phase 3 pivotal trials, which met primary efficacy endpoints and showed a favorable safety profile.
Keratoconus, often diagnosed in the teenage years, leads to thinning and weakening of the cornea, potentially resulting in vision loss or blindness. It is a leading cause for corneal transplants in the U.S. Glaukos' iLink therapy, including its FDA-approved Photrexa® or Epi-off, is the first therapy shown to slow or halt the disease's progression.
If approved, Epioxa would be the first FDA-sanctioned, non-invasive corneal cross-linking therapy that preserves the corneal epithelium. It utilizes a unique drug formulation, a stronger UV-A irradiation protocol, and supplemental oxygen to enhance cross-linking.
Glaukos, known for its innovations in eye care, including the development of Micro-Invasive Glaucoma Surgery (MIGS) and the commercial launch of iDose® TR for glaucoma treatment, continues to expand its pipeline with technologies aimed at improving the standard of care for chronic eye diseases.
This announcement is based on a press release statement, and the future of Epioxa is subject to the FDA's review and approval process. Glaukos has cautioned that forward-looking statements in the release are based on current expectations and subject to risks and uncertainties. The company maintains a healthy gross profit margin of 76.6% and has demonstrated strong revenue growth of 18.7% over the last twelve months. For deeper insights into Glaukos's financial health and market position, investors can access comprehensive analysis through InvestingPro, which offers detailed research reports and additional ProTips for over 1,400 US stocks.
In other recent news, Glaukos Corporation and Procept BioRobotics have seen significant developments in their financial performances and growth strategies. Piper Sandler analysts expressed optimism for several healthcare companies, including Glaukos, ahead of a major investor conference. They expect Glaukos to maintain its premium valuation and strong growth profile. Procept BioRobotics, on the other hand, initiated a public offering of common stock valued at $175 million and reported robust revenue growth of 66% in the third quarter.
Analysts from firms such as Citi, UBS, and Mizuho (NYSE:MFG) Securities have provided varied outlooks for these companies. Citi upgraded Glaukos from Neutral to Buy, expecting a positive inflection in sales of its iDose product in 2025. UBS initiated coverage on Glaukos with a Buy rating, attributing the company's projected high-20% compound annual growth rate to the success of iDose. Mizuho Securities, however, retained a Neutral rating on Glaukos but increased the price target in anticipation of a significant year ahead for the company.
Procept BioRobotics has been rated Overweight by Morgan Stanley (NYSE:MS), indicating a pathway for further upside. Jefferies maintains a Hold rating on Procept BioRobotics' stock despite acknowledging the potential of the company's newly approved Hydros system. Truist Securities maintained a Buy rating on Procept BioRobotics, raising its price target following the company's strong third-quarter performance.
These developments provide a snapshot of the recent financial performance and market expectations for Glaukos Corporation and Procept BioRobotics.
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