Eyenovia, Inc. - EYEN STOCK NEWS

Eyenovia (NASDAQ: EYEN) announced that its Phase 3 CHAPERONE study evaluating low-dose atropine in the Optejet platform for pediatric progressive myopia is not meeting its primary endpoint. The independent Data Review Committee found no significant difference in myopia progression between treatment arms (0.01% and 0.1% atropine) and placebo among 252 evaluable patients. The primary endpoint targeted less than 0.5 diopter progression in visual acuity over three years. While safety analysis showed all dosages were well-tolerated, the company plans to terminate the study and is considering strategic options including business combination, reverse merger, or asset sales.

Eyenovia (NASDAQ: EYEN) reported Q3 2024 financial results and corporate updates. Key developments include the U.S. launch of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation, advancement of Phase 3 CHAPERONE study for MicroPine in pediatric myopia, and commencement of Mydcombi registration batches in second-generation Optejet device. The company reported a net loss of $7.9 million ($0.11 per share) compared to $7.3 million in Q3 2023. Operating expenses increased 10.6% to $7.2 million. Cash position stood at $7.2 million, with $10.7 million raised in combined net proceeds. The company expanded Mydcombi's reach to 230 new offices from April through September 2024.

Eyenovia (NASDAQ: EYEN), an ophthalmic technology company focused on its proprietary Optejet medication dispensing platform, will release its Q3 2024 financial results on Tuesday, November 12th, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET to discuss the results. Investors can join via phone (1-877-407-9039 domestic, 1-201-689-8470 international) or through the company's website. The webcast will be archived for one year on Eyenovia's website.

Eyenovia (NASDAQ: EYEN) announced two significant developments for its Optejet® dispenser. A study published in the Journal of Ocular Pharmacology and Therapeutics demonstrated that Optejet can deliver latanoprost with significantly less exposure to harmful preservatives compared to traditional eye drops, avoiding cytotoxicity associated with larger volumes. Additionally, a Phase 4 study of Mydcombi, presented at the American Academy of Optometry, showed that a half-dose achieved clinically relevant pupil dilation with favorable safety outcomes. The study reported mean pupil diameter changes from 2.74mm at baseline to 6.42mm after 30 minutes, with 67% of eyes dilated to ≥6mm.

Eyenovia, Inc. (NASDAQ: EYEN) announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, showcasing results from their successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05%. This study led to FDA approval for treating inflammation and pain after ocular surgery. The presentation will highlight the drug's efficacy in providing rapid relief from inflammation and pain, with improvements visible as early as four days post-surgery compared to placebo. It also demonstrated faster visual acuity improvement and a favorable safety profile.

Eyenovia launched clobetasol commercially on September 26, 2024. The drug is available through their pharmacy partner, Medvantx, or directly via EyenoviaRx.com. With its convenient twice-daily dosing and streamlined distribution model, Eyenovia believes clobetasol will quickly become a preferred post-operative steroid among physicians and patients.

Eyenovia, Inc. (NASDAQ: EYEN) has begun manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, using the advanced Gen-2 Optejet dispensing platform. This marks a important step in the approval process for the new device, which is designed for an optimized user experience and extended patent protection through 2041.

The Gen-2 Optejet features improvements such as one-button use and compatibility with Eyenovia's digital compliance monitoring program, Optecare™. The company received feedback from the FDA in July that aligned with their device qualification plan, allowing for efficient progress in manufacturing and testing.

Eyenovia expects to complete testing of Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026. The Gen-2 Optejet platform may also provide lower manufacturing costs and streamline future regulatory interactions for additional therapeutics, including those in development partnerships.

Eyenovia, Inc. (NASDAQ: EYEN) has announced a $4 million registered direct offering of common stock and warrants. The company will sell 8,695,653 shares (or equivalents) and warrants to purchase up to 8,695,653 shares at a combined price of $0.46 per share and accompanying warrant. The warrants have an exercise price of $0.50 per share, will be exercisable after six months, and expire in five years. The offering is expected to close around September 30, 2024.

Eyenovia plans to use the net proceeds for commercialization activities for Mydcombi and clobetasol propionate, completing the CHAPERONE pediatric myopia clinical study, working capital, and general corporate purposes, including potential debt repayment. A.G.P./Alliance Global Partners is the lead placement agent, with Brookline Capital Markets as co-placement agent.

Eyenovia, Inc. (NASDAQ: EYEN) has announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% (Clobetasol) for treating post-operative inflammation and pain following ocular surgery. As the first new ophthalmic steroid approved in over 15 years, Clobetasol offers a twice-daily dosing regimen and streamlined distribution to eliminate insurance complications.

Recent market research involving 100 ophthalmic surgeons revealed strong interest in Clobetasol. Key findings include:

• Efficacy ranked as the most important characteristic, with ~80% of patients experiencing complete pain relief within four days post-surgery
• Safety profile was highlighted, with no single adverse event affecting more than 2% of patients
• 53% of respondents cited managed care hurdles as a significant issue, which Clobetasol's fixed-price model aims to address

Formosa Pharmaceuticals (6838.TW) has made its first shipment of APP13007 (Clobetasol Propionate Ophthalmic Suspension, 0.05%) to the United States for commercialization. The drug, developed using Formosa's APNT® nanotechnology platform, is the first FDA-approved ophthalmic use of the super-potent corticosteroid, clobetasol propionate. Eyenovia (NASDAQ: EYEN), Formosa's U.S. partner, is set to begin commercialization in late September.

APP13007 offers a more convenient dosing regimen with twice-daily administration, compared to other treatments requiring up to four doses per day. The ophthalmic steroid market is valued at $1.3 billion, with nearly 7 million ophthalmic surgeries performed annually in the U.S. Formosa is also preparing for regulatory submissions in other regions to expand its international market presence.