Eyenovia Inc Stock Price, News & Analysis

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.

Eyenovia, Inc. (NASDAQ: EYEN) announced the acceptance of its New Drug Application (NDA) by the FDA for MydCombi™, a new mydriatic agent aimed at enhancing pupil dilation during eye exams. The product, utilizing the innovative Optejet® delivery system, could potentially address patient discomfort associated with traditional dilation methods. If approved, MydCombi would be the first of its kind to offer a microdosed solution. Phase 3 trials showed safety and efficacy, with 94% of eyes achieving significant dilation. The PDUFA date is set for Q4 2023.

Eyenovia, Inc. (NASDAQ: EYEN) will host a KOL webinar titled “Presbyopia in Focus: Unlocking One of the Biggest Market Opportunities in Ophthalmology” on February 22, 2021, at 1:00 PM ET. Key speakers include Dr. David F. Chang and Dr. Sean Ianchulev, discussing presbyopia treatment and Eyenovia's MicroLine technology, as the condition affects approximately 113 million people in the U.S. Eyenovia is evaluating MicroLine in two Phase 3 studies, VISION-1 and VISION-2, with results expected in mid-2021. The webinar will include a Q&A session.

Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic biopharmaceutical company, announced that Dr. David Wirta will present at the Ophthalmology Innovation Summit Presbyopia Innovation Showcase on January 28th. His talk will address the challenges faced by presbyopia patients and discuss the advantages of using Eyenovia's pilocarpine via the novel Optejet® dispenser. Currently, Eyenovia is assessing its MicroLine formulation in two Phase 3 studies, VISION-1 and VISION-2, which began enrollment in December 2020. These innovations aim to improve the quality of life for the 113 million Americans affected by presbyopia.

Eyenovia, Inc. (NASDAQ: EYEN) announced that Dr. Sean Ianchulev will participate in a panel discussion on presbyopia at the LifeSci Partners 10th Annual Corporate Access Event on January 8, 2021. Eyenovia is developing MicroLine, a proprietary pilocarpine formulation aimed at improving near vision in patients with presbyopia, with top-line results expected in the first half of 2021. Currently, there are no FDA-approved pharmacologic therapies for presbyopia, affecting around 113 million Americans. The panel is titled 'The First Drugs for Far-Sightedness are Near.'

Eyenovia, Inc. (NASDAQ: EYEN) has submitted a New Drug Application (NDA) to the FDA for MydCombi™, a first-of-its-kind microdosed mydriatic agent. This submission follows the initial enrollment in the Phase 3 VISION-1 study for MicroLine aimed at addressing presbyopia, with data expected in early 2021. MydCombi aims to enhance pupil dilation efficiency during eye exams, reducing patient discomfort and exam duration with its innovative Optejet® dispenser. Phase 3 studies demonstrated a 94% dilation success rate, with adverse events reported at a low 3.1%. Approval could launch MydCombi by late 2021 or early 2022.

Eyenovia, Inc. (NASDAQ: EYEN) has announced patient enrollment for its Phase 3 VISION-1 study of MicroLine, a proprietary pilocarpine formulation aimed at improving near vision in presbyopia patients. This condition, affecting around 113 million Americans over 40, typically requires corrective eyewear. The trial aims for quick enrollment and topline data in the first half of 2021, despite potential COVID-19 impacts. The primary endpoint will assess same-day improvements in near visual acuity.

Eyenovia, Inc. (NASDAQ: EYEN) announced that the U.S. FDA has accepted its IND application for MicroLine, a pilocarpine formulation aimed at enhancing near vision in presbyopia patients. The company plans to initiate the Phase 3 VISION program, starting with the VISION-1 study later this month. Presbyopia affects around 113 million Americans, with MicroLine offering a microdosed alternative to traditional eye drops using the Optejet® dispenser for precise dosing. The VISION trials will focus on assessing the effectiveness of MicroLine in adults aged 40-60 with presbyopia.