NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:EYEN), an ophthalmic technology firm, has announced the U.S. commercial availability of its FDA-approved clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain management following ocular surgery. The product, branded as Clobetasol™, is noted for being the first new ophthalmic steroid approved in over a decade.
Michael Rowe, CEO of Eyenovia, highlighted the significance of the launch for the company and the advancement it represents in ocular surgery treatment options. Clobetasol's twice-a-day dosing regimen and a distribution model designed to sidestep insurance complications are expected to draw the interest of eye care professionals.
A survey commissioned by Eyenovia pointed to a strong interest from ophthalmic surgeons, with efficacy being the top characteristic sought in post-operative steroids. Clinical studies indicated that Clobetasol provided complete pain relief to approximately 80% of patients within four days post-surgery. Additionally, the safety profile of clobetasol was emphasized, with no single adverse event affecting more than 2% of patients.
The market research also identified managed care hurdles as a significant issue for 53% of surveyed surgeons when prescribing ophthalmic steroids. Clobetasol's fixed low price, irrespective of patient insurance status, was seen as a positive move to alleviate administrative burdens.
Eyenovia's partnership with Formosa Pharma also aims to expand the use of Clobetasol in treating dry eye through the Optejet® platform technology. The company continues to focus on the commercialization of its products, including MYDCOMBI® for mydriasis and ongoing development of treatments for pediatric progressive myopia.
The information provided is based on a press release statement from Eyenovia, Inc. The company's forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. Eyenovia does not assume any obligation to update forward-looking statements. For further details on Clobetasol and MYDCOMBI, please refer to their respective safety information websites.
In other recent news, Eyenovia, Inc. has faced a potential delisting warning from Nasdaq due to its stock trading below the minimum $1.00 per share requirement for 30 consecutive business days. The pharmaceutical company has until March 17, 2025, to regain compliance. Eyenovia has also appointed Andrew Jones as its new Chief Financial Officer, as it prepares for the launch of clobetasol and advances its late-stage asset MicroPine.
The company recently announced an agreement to sell 12,850,000 shares of its common stock, expecting to generate gross proceeds of around $5.14 million. Eyenovia has also revealed plans for a public offering of its common stock or pre-funded warrants. H.C. Wainwright has maintained a Buy rating on Eyenovia's shares, recognizing the potential of the company's Optejet delivery system to drive significant growth.
Despite recording a net loss of $11.1 million and an increase in operating expenses, Eyenovia is preparing for the launch of FDA-approved Clobetasol and the Gen 2 Optejet device, expected in early 2025. These are among the recent developments in Eyenovia's growth strategy.
InvestingPro Insights
As Eyenovia, Inc. (NASDAQ: EYEN) propels forward with the commercial launch of its new ophthalmic steroid, Clobetasol™, the financial landscape of the company is a critical factor for investors to consider. The company's market capitalization stands at $39.35 million, reflecting the current valuation of the firm in the market.
InvestingPro Tips suggest that while analysts anticipate sales growth in the current year, they remain cautious about the company's profitability. In fact, three analysts have revised their earnings forecasts upwards for the upcoming period, indicating a potential optimistic outlook on the company's revenue prospects. However, it is noted that Eyenovia is quickly burning through cash, which could be a concern for long-term sustainability.
Moreover, Eyenovia's stock price movements have been quite volatile, which may attract investors looking for high-risk, high-reward opportunities but could also signal caution for those seeking more stable investments. The company's stock has experienced a significant price decline over the past year, with a 71.57% drop in the one-year price total return as of the latest available data.
In terms of financial metrics, Eyenovia's Price/Earnings (P/E) Ratio is currently at -0.68, suggesting that the company is not generating net income relative to its share price. This is reinforced by the adjusted P/E ratio for the last twelve months as of Q2 2024, which stands at -1.04. Additionally, the company's gross profit margin for the same period is at an alarming -17609.84%, indicating substantial costs in relation to revenue.
Investors and potential shareholders can find more detailed analysis and additional InvestingPro Tips for Eyenovia at https://www.investing.com/pro/EYEN, with a total of 15 tips available that provide further insights into the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.