Core Insights - Eyenovia, Inc. has begun manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, marking a significant step in the approval process for its Gen-2 Optejet dispensing platform [1][2]. Group 1: Product Development - Mydcombi will undergo 12-month stability testing and functional testing in the Gen-2 Optejet device, following FDA feedback received in July [2]. - The Gen-2 Optejet device features advancements such as one-button use and compatibility with the digital compliance monitoring program, Optecare™ [3]. Group 2: Strategic Outlook - The introduction of the Gen-2 Optejet is viewed as a significant inflection point for the company, potentially leading to lower manufacturing costs and streamlined regulatory interactions for future therapeutics [3]. - Eyenovia anticipates completing testing of Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026 [4]. Group 3: Company Overview - Eyenovia is focused on the commercialization of Mydcombi for mydriasis and is developing additional products, including clobetasol propionate ophthalmic suspension and treatments for pediatric progressive myopia [5].

Core Viewpoint - Eyenovia, Inc. has announced a securities purchase agreement for the sale of approximately 8.7 million shares of common stock and warrants, aiming to raise around $4 million to support its commercialization efforts and clinical studies [1][2]. Group 1: Offering Details - The company will sell 8,695,653 shares of common stock at a price of $0.46 per share, along with warrants to purchase an equal number of shares [1]. - The warrants have an exercise price of $0.50 per share, are exercisable six months post-issuance, and will expire five years from the initial exercise date [1]. - The closing of the offering is expected around September 30, 2024, pending customary closing conditions [1]. Group 2: Use of Proceeds - The gross proceeds from the offering are estimated to be approximately $4 million before deducting fees and expenses [2]. - The net proceeds will be allocated for commercialization activities for Mydcombi and clobetasol propionate, completion of the CHAPERONE pediatric myopia clinical study, and general corporate purposes, including potential debt repayment [2]. Group 3: Placement Agents - A.G.P./Alliance Global Partners is the lead placement agent for the offering, with Brookline Capital Markets acting as a co-placement agent [3]. Group 4: Company Overview - Eyenovia, Inc. specializes in ophthalmic technology, with FDA-approved products including Mydcombi and Clobetasol Propionate Ophthalmic Suspension, and is developing the Optejet® device for pediatric progressive myopia [6].

NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% ("Clobetasol"), approved by the FDA for the treatment of post-operative inflammation and pain following ocular surgery. "The commercial launch of Clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a ...

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced that its strategic partner, Taiwan-based Formosa Pharmaceuticals (TWO:6838), was granted a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") to allow for shipment of commercial product to the U.S. Clobetasol is ...

NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced the appointment of experienced finance and accounting executive Andrew Jones as Chief Financial Officer. Mr. Jones brings to the Eyenovia team more than 30 years of diverse finance and accounting leadership experience spanning therapeutics and medical technology/devices, most recently serving as ...

Core Viewpoint - Eyenovia, Inc. has successfully closed a public offering of 12,850,000 shares of common stock at a price of $0.40 per share, raising approximately $5.14 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering consisted of 12,850,000 shares priced at $0.40 each, resulting in gross proceeds of about $5.14 million [1][2]. - The net proceeds will be utilized for commercialization activities for Mydcombi and clobetasol propionate, completion of the CHAPERONE pediatric myopia clinical study, and general corporate purposes, including potential debt repayment [2]. Group 2: Placement Agent - Dawson James Securities, Inc. served as the placement agent for the offering [3]. Group 3: Regulatory Information - The securities were offered under a previously filed shelf registration statement on Form S-3, effective since December 23, 2021, with the offering conducted via a prospectus supplement [4].

Eyenovia Inc EYEN stock is trading higher on Thursday after its plunge yesterday, with a session volume of 6.7 million, versus an average volume of 1.33 as per data from Benzinga Pro. On Wednesday, the ophthalmic technology company agreed to sell 12.85 million shares at $0.40 per share. The aggregate gross proceeds to the company from the offering are expected to be approximately $5.14 million. The company will use the net proceeds to fund commercialization activities for its products, Mydcombi and clobetas ...

Core Viewpoint - Eyenovia, Inc. has announced an agreement to sell 12,850,000 shares of common stock at a price of $0.40 per share, aiming to raise approximately $5.14 million in gross proceeds to fund various activities including commercialization and clinical studies [1][2]. Group 1: Offering Details - The closing of the Offering is expected around August 22, 2024, pending customary closing conditions [2] - Dawson James Securities, Inc. is acting as the placement agent for the Offering [2] - The net proceeds will be used for commercialization activities for Mydcombi and clobetasol propionate, completing the CHAPERONE pediatric myopia clinical study, and for working capital, including potential debt repayment [2] Group 2: Company Overview - Eyenovia, Inc. specializes in ophthalmic technology, commercializing Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension, and developing the Optejet® device for pediatric progressive myopia [5]

Core Viewpoint - Eyenovia, Inc. plans to offer and sell shares of its common stock in a best efforts offering, subject to market conditions, with no assurance on the completion or terms of the offering [1]. Group 1: Offering Details - The offering will be conducted by Eyenovia and is subject to market conditions, with no guarantee on the timing or size of the offering [1]. - The net proceeds from the offering will be used for commercialization activities for Mydcombi and clobetasol propionate, completing the CHAPERONE pediatric myopia clinical study, and for working capital, which may include repaying existing debt [2]. - Dawson James Securities, Inc. is the sole placement agent for the offering [2]. Group 2: Regulatory Information - The offering is made under a shelf registration statement on Form S-3, filed with the SEC on December 14, 2021, and declared effective on December 23, 2021 [3]. - A prospectus supplement and accompanying prospectus will be filed with the SEC, providing details about the offering [3]. Group 3: Company Overview - Eyenovia, Inc. is an ophthalmic technology company that commercializes Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension, and is developing the Optejet® device for pediatric progressive myopia [5].

Eyenovia, Inc. (EYEN) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. The power of a changing ea ...