Eyenovia Inc Stock Price, News & Analysis

Eyenovia, Inc. (NASDAQ: EYEN) announced participation in two upcoming virtual healthcare conferences: the Ladenburg Thalmann 2021 Healthcare Conference on July 14 and the William Blair Biotech Focus Conference 2021 from July 14-15. The company focuses on developing advanced therapeutics through its proprietary MAP™ technology for conditions like presbyopia and myopia progression. Management will provide a corporate overview and engage in one-on-one meetings with investors. For more details, visit their website.

Eyenovia, Inc. (NASDAQ: EYEN) reported positive results from its Phase 3 VISION-1 clinical trial for its pilocarpine solution, MicroLine, aimed at treating presbyopia. Key findings include a statistically significant improvement in near vision over placebo, with 71% of subjects reporting meaningful vision enhancement. Eyenovia plans to initiate a second trial, VISION-2, in 2021 and anticipates making a New Drug Application submission. The FDA has set a PDUFA date of October 28, 2021, for its MydCombi product, while the company also announced licensing agreements for its MicroPine treatment, potentially earning up to $100 million.

Eyenovia, Inc. (NASDAQ: EYEN) announced that its VISION-1 study for the MicroLine pilocarpine formulation aimed at improving near vision in presbyopic adults achieved its primary endpoint. The study demonstrated a significant improvement in near visual acuity compared to placebo, with no serious adverse events reported. Eyenovia is preparing for a second Phase 3 study, VISION-2, and a New Drug Application (NDA) submission. The potential market for MicroLine is substantial, with around 18 million presbyopic individuals in the U.S.

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.