NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:EYEN), an ophthalmic biopharmaceutical company, has announced a collaboration with Senju Pharmaceutical Co., Ltd. to develop a new treatment for chronic dry eye disease using Senju's SJP-0035 with Eyenovia's Optejet® technology. The partnership aims to create a drug-device combination product that could potentially improve the quality of life for millions affected by this condition.
Chronic dry eye is a significant global health issue, with an estimated market of $5 billion. In the United States alone, the condition affects nearly sixteen million people, with current treatments costing over $3 billion. The collaboration between Eyenovia and Senju represents a strategic effort to address this widespread problem with a novel approach.
SJP-0035 has previously undergone Phase 1 and Phase 2 studies, showing promising tolerance in over 250 subjects. The next step for the two companies is to present a clinical development proposal to the U.S. Food and Drug Administration (FDA) that could support a New Drug Application (NDA) filing. If the FDA consultations are successful, a Phase 2b trial will evaluate the efficacy of SJP-0035 when administered with the Optejet dispenser.
Michael Rowe, CEO of Eyenovia, expressed optimism about the collaboration, citing the need for better treatment options for chronic dry eye symptoms that significantly impact daily life. A recent survey highlighted the gap in effective treatments, with only 13% of patients experiencing lasting relief despite adherence to treatment plans.
Senju, a leading Japanese pharmaceutical company specializing in ophthalmology, brings a wealth of expertise to the partnership. Mitsuyoshi Isaka, a corporate executive officer at Senju, emphasized the potential of SJP-0035's unique mechanism of action to provide additional relief for dry eye patients.
The companies anticipate meeting with the FDA later this year, to finalize a definitive agreement and commence a Phase 2b study in 2025. Success in the trials could lead to the launch of two Phase 3 studies by 2026.
This announcement is based on a press release statement by Eyenovia, Inc.
In other recent news, NovaBay Pharmaceuticals and Eyenovia have begun co-promotion activities, targeting large ophthalmic surgery centers with their respective products, Avenova and MydCombi. The collaboration also prepares the market for Eyenovia's forthcoming product, Clobetasol Propionate Ophthalmic Suspension, expected to be available in August 2024.
Eyenovia recently reported a Q1 2024 net loss of $10.9 million and unrestricted cash reserves of $8 million. The company's licensing agreements with Arctic Vision have generated $16 million, with potential for additional milestones and royalties.
Eyenovia also revealed a collaboration with SGN Nanopharma for potential dry eye treatment and progress in commercializing Mydcombi. The company plans to expedite the development of MicroPine and introduce Gen 2 into the commercial market.
A data readout for MicroPine is expected in Q4 2024. These are among the recent developments in the companies' journey towards profitability.
InvestingPro Insights
In light of Eyenovia's recent announcement regarding their collaboration with Senju Pharmaceutical, it's pertinent to consider the company's financial and market performance. According to InvestingPro, analysts are expecting sales growth for Eyenovia in the current year, indicating a positive outlook on the company's revenue prospects. This aligns with the potential market expansion driven by the novel dry eye treatment.
However, it's important to note that Eyenovia has been grappling with weak gross profit margins, with a reported gross profit margin of -22779.04% for the last twelve months as of Q1 2024. Additionally, the company's stock price has been quite volatile, which may reflect investor sentiment about the inherent risks in the biopharmaceutical industry and the company's financial health. The company's valuation also implies a poor free cash flow yield, which could be a concern for investors looking for companies with strong cash generation capabilities.
Despite these challenges, Eyenovia has experienced a strong return over the last three months, with a 121.16% price total return, which may interest investors looking for momentum in the stock's performance. With these metrics in mind, investors can gain a comprehensive view of Eyenovia's financial health and market performance as they evaluate the company's future prospects, especially in light of the recent strategic partnership.
For those interested in deeper analysis and additional insights, there are 12 more InvestingPro Tips available for Eyenovia. Subscribers can access these tips to inform their investment decisions, and new users can take advantage of the promo code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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