Eyenovia Inc Stock Price, News & Analysis

Eyenovia, Inc. (NASDAQ: EYEN) announced key developments on May 12, 2021, including the confirmation of its PDUFA date for MydCombi as October 28, 2021. The company completed patient enrollment in its Phase 3 VISION-1 study for MicroLine, with top-line data expected soon. Financial results showed a net loss of $5.4 million for Q1 2021, slightly reduced from $5.5 million in Q1 2020. Eyenovia secured a $25 million credit facility with Silicon Valley Bank to support ongoing operations.

Eyenovia, Inc. (NASDAQ: EYEN) has secured a $25 million credit financing facility from Silicon Valley Bank. This non-dilutive financing is expected to provide significant operational flexibility, with $7.5 million received at closing and the remaining $17.5 million available upon meeting specific milestones. The funds will support Eyenovia's upcoming Mydcombi launch, the development of MicroLine, and additional ophthalmic indications leveraging their Optejet microdosing technology.

Eyenovia, Inc. (NASDAQ: EYEN) will announce its Q1 2021 financial results on May 12, 2021, after market close. A conference call will follow at 4:30 PM ET, featuring CEO Dr. Sean Ianchulev, COO Michael Rowe, and CFO John Gandolfo. Participants can join by calling 877-407-9039 or 201-689-8470, using conference code 13718776. A live webcast is accessible on Eyenovia's investor relations page and will be archived for one year.

Eyenovia focuses on developing microdose array print (MAP) therapeutics for eye conditions.

Eyenovia, Inc. (NASDAQ: EYEN) has appointed Dr. Julia Haller, a distinguished ophthalmologist, to its Board of Directors. Dr. Haller's extensive experience as an ophthalmic surgeon and scientist is expected to greatly benefit Eyenovia as it advances its late-stage pipeline focused on ophthalmic treatments. CEO Dr. Sean Ianchulev expressed confidence that Dr. Haller's leadership will enhance the company's goals of achieving clinical and regulatory milestones. Dr. Haller has held significant positions at Wills Eye Hospital and has published over 400 scientific works, reinforcing her reputation in the field.

Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic firm, announced its financial results for Q4 and full year 2020. It reported a net loss of $4.2 million in Q4, an improvement from $5.2 million in Q4 2019. Total revenue for the year was approximately $2.0 million, mainly from a licensing milestone. The FDA has accepted its NDA for MydCombi™, with a PDUFA date set for October 28, 2021. Additionally, patient enrollment in the Phase 3 VISION-1 study is complete, with topline data expected in Q2 2021. The company ended 2020 with $28.4 million in cash.

Eyenovia, Inc. (NASDAQ: EYEN) has partnered with EVERSANA to commercialize MydCombi, a microdosed mydriatic agent, pending FDA approval. This collaboration follows the FDA's acceptance of Eyenovia's New Drug Application for MydCombi, aimed at enhancing pupil dilation efficiency during eye exams. EVERSANA will exclusively distribute MydCombi in the U.S. and assist in establishing an e-commerce platform for sales analytics. Eyenovia anticipates that this partnership will streamline the launch process while keeping costs lower than typical in ophthalmology.

Eyenovia, Inc. (NASDAQ: EYEN) will release its financial results for Q4 and full year 2020 on March 25, 2021, post-market close. The company, focused on ophthalmic therapeutics, will host a conference call at 4:30 PM ET on the same day. Attendees can join via phone or through the company's website. The call will feature insights from key executives, including CEO Dr. Sean Ianchulev. Following the live session, the call will be archived on their website for one year, providing accessible information for investors.

Eyenovia (NASDAQ: EYEN) announced the publication of results from Phase 3 studies demonstrating the safety and efficacy of a micro-dosed tropicamide-phenylephrine fixed combination for pupil dilation. In the trials, 93% of treated eyes achieved 6 mm dilation at 35 minutes compared to lower rates with individual agents. Adverse events were mild in 3% of participants. The FDA has accepted Eyenovia's New Drug Application for MydCombi, with a potential approval date set for Q4 2021. The novel Optejet dispenser offers a touch-free, precise delivery system to enhance patient comfort and reduce medication waste.

Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic company, will participate in the 33rd Annual Roth Conference from March 15-17, 2021. They will host virtual one-on-one meetings to connect with institutional investors. Eyenovia focuses on developing advanced therapeutics utilizing its proprietary microdose array print (MAP™) technology, specifically targeting presbyopia, myopia progression, and mydriasis. For more information, visit www.eyenovia.com.