NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:EYEN), an ophthalmic technology company, has initiated the manufacturing of registration batches for Mydcombi in its Gen-2 Optejet dispensing platform, marking a pivotal step in the product's FDA approval process. Mydcombi, already approved for mydriasis, will be subjected to a 12-month stability testing along with other functional assessments as part of the Gen-2 Optejet device evaluation.
The company's CEO, Michael Rowe, expressed satisfaction with the FDA's feedback, which aligns with Eyenovia's device qualification plan from July. Rowe highlighted the Gen-2 Optejet's enhancements, such as its one-button operation and integration with the Optecare digital compliance monitoring program, as significant advancements for the company.
The Gen-2 Optejet is anticipated to not only improve the user experience but also reduce manufacturing costs and simplify regulatory processes for future therapeutics. These benefits are expected to extend to Eyenovia's pipeline products and those under development partnerships.
Eyenovia foresees the completion of Mydcombi registration batch testing by the end of next year, with a potential Supplemental New Drug Application (SNDA) filing in early 2026. The company is currently concentrating on the commercialization of Mydcombi for mydriasis, a clobetasol propionate ophthalmic suspension for post-surgical pain and inflammation, and the late-stage development of treatments for pediatric progressive myopia.
This initiative is a part of Eyenovia's broader efforts to leverage its proprietary Optejet platform for advanced ophthalmic products. The information in this article is based on a press release statement from Eyenovia.
In other recent news, Eyenovia, Inc. has secured a financing agreement to raise $4 million through the sale of shares and warrants. The biopharmaceutical company plans to use the proceeds to fund the commercialization of its FDA-approved products Mydcombi and clobetasol propionate, finalize the CHAPERONE pediatric myopia clinical study, and support general corporate activities. A.G.P./Alliance Global Partners (NYSE:GLP) is leading the placement, with Brookline Capital Markets serving as a co-agent.
Additionally, Eyenovia has launched the FDA-approved Clobetasol, the first new ophthalmic steroid in over a decade, for post-operative inflammation and pain management. Clinical studies suggest Clobetasol provides complete pain relief to approximately 80% of patients within four days post-surgery.
Furthermore, the company has announced plans for a public offering to sell nearly 13 million shares of its common stock, expected to generate gross proceeds of around $5.14 million. Eyenovia also appointed Andrew Jones as its new Chief Financial Officer. H.C. Wainwright continues to maintain a Buy rating on Eyenovia's shares, recognizing the potential of the company's Optejet delivery system.
Despite recording a net loss of $11.1 million and an increase in operating expenses, Eyenovia is preparing for the launch of the Gen 2 Optejet device, expected in early 2025. However, the company has received a potential delisting warning from Nasdaq due to its stock trading below the minimum $1.00 per share requirement for 30 consecutive business days.
InvestingPro Insights
As Eyenovia (NASDAQ: EYEN) advances its Gen-2 Optejet platform, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at a modest $44.36 million, reflecting its current position as a niche player in the ophthalmic technology sector.
InvestingPro data reveals that Eyenovia's revenue for the last twelve months as of Q2 2023 was just $0.03 million, indicating the company is still in its early stages of commercialization. This aligns with the article's focus on the development and potential future approval of Mydcombi and other pipeline products.
An InvestingPro Tip highlights that analysts anticipate sales growth in the current year, which could be attributed to the progress of Mydcombi and other products in Eyenovia's pipeline. This expectation of growth is crucial as the company moves towards potential commercialization of its innovative ophthalmic products.
Another relevant InvestingPro Tip notes that Eyenovia is quickly burning through cash. This is not uncommon for biotechnology companies in the development stage, but it underscores the importance of successful product launches and potential partnerships to sustain operations and fund future growth.
For investors considering Eyenovia's potential, it's worth noting that InvestingPro offers 11 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be particularly valuable given the company's current stage of development and the potential impact of its innovative Optejet platform on the ophthalmic market.
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