Eyenovia halts myopia study after missing primary endpoint

NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:), a biopharmaceutical company specializing in ophthalmic therapies, announced today that its CHAPERONE study will be discontinued following a review by an independent Data Review Committee (DRC). The Phase 3 clinical trial was evaluating the efficacy of Eyenovia's proprietary drug-device combination for treating pediatric progressive myopia, but it did not meet the primary efficacy endpoint.

The DRC, after examining safety and efficacy data from 252 patients, concluded that there was no significant difference in the progression of myopia between the two active treatment arms and the placebo group. Despite the study results, the safety analysis indicated that all dosages, including the placebo, were well-tolerated with only mild and infrequent adverse events reported.

Michael Rowe, CEO of Eyenovia, expressed disappointment with the outcome but extended gratitude to the participants and healthcare professionals involved in the trial. The company is now set to fully review the data and consider strategic options that may include a business combination, reverse merger, or asset sales.

Eyenovia's current portfolio includes treatments for post-surgical pain and inflammation, and mydriasis, leveraging its Optejet dispensing platform. The platform is designed for enhanced safety, ease of use, and potentially improved compliance in treating chronic front-of-the-eye diseases.

The company also has licensing and development agreements for additional indications, including dry eye, which could benefit from the Optejet technology. Further details on Eyenovia's strategic evaluation will be shared upon completion.

This news is based on a press release statement and reflects the latest developments from Eyenovia regarding its clinical trial and future business considerations.

In other recent news, Eyenovia, a biopharmaceutical company, has reported significant advancements in its product offerings and collaborations during its third-quarter earnings call. Despite a net loss of $7.9 million for Q3 2024, Eyenovia is nearing Phase III efficacy data readout for MicroPine, a product targeting pediatric progressive myopia, and has launched MydCombi and Clobetasol, which are showing strong interest and efficacy. The company is also developing its Gen 2 Optejet device, promising improved manufacturing efficiency and cost margins up to 90%. Collaborations with Formosa Pharmaceuticals, Senju Pharmaceuticals, and SGN Nanopharma are in place to address the $3 billion U.S. dry eye market. Eyenovia has approximately $7.2 million in cash on hand, supported by $10.7 million from recent securities offerings. These are among the recent developments as the company continues to expand its portfolio and partnerships.

InvestingPro Insights

The recent setback in Eyenovia's CHAPERONE study has significantly impacted the company's market performance. According to InvestingPro data, Eyenovia's stock has taken a substantial hit, with a 30.46% decline in the past week alone. This sharp drop aligns with the announcement of the study's discontinuation and reflects investor concerns about the company's future prospects.

Despite the disappointing trial results, InvestingPro Tips highlight that analysts anticipate sales growth for Eyenovia in the current year. This projection could be related to the company's other products in development, such as treatments for post-surgical pain and inflammation, which utilize the Optejet dispensing platform.

However, it's important to note that Eyenovia is currently operating at a loss, with a negative gross profit of $5.65 million over the last twelve months. The company's financial position is further strained by its cash burn rate, as indicated by another InvestingPro Tip. This financial pressure may have contributed to management's decision to explore strategic options, including potential business combinations or asset sales.

For investors seeking a more comprehensive analysis, InvestingPro offers 20 additional tips for Eyenovia, providing a deeper understanding of the company's financial health and market position in these challenging times.

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