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Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print delivery technology, today announced that Professor Mark Bullimore, PhD and April Jasper, OD have joined Eyenovia’s Scientific Advisory Board.
“We are very pleased to welcome two highly accomplished and respected optometrists to our Scientific Advisory Board,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. “We believe Professor Mark Bullimore and Dr. April Jasper will bring a wealth of scientific, academic and practical experience in optometry and more specifically in childhood myopia and presbyopia to our company. We look forward to leveraging their experience as we continue enrolling patients in our Phase III CHAPERONE study for progressive myopia and prepare to initiate our Phase III VISION studies for presbyopia in 2020.”
Professor Mark Bullimore is an internationally renowned scientist, speaker, and educator. He is currently an Adjunct Professor at the University of Houston College of Optometry and is also the Associate Editor of Ophthalmic and Physiological Optics. He is a Fellow of the American Academy of Optometry and a Gold Fellow of the Association for Research in Vision and Ophthalmology. Previously, he was the Dean of the Southern California College of Optometry at Marshall B. Ketchum University and Editor of Optometry and Vision Science. He received his Optometry degree and PhD in Vision Science from Aston University in Birmingham, England.
Dr. April Jasper has extensive experience in various modes of optometric practice and currently owns and operates Advanced Eyecare Specialists, a group optometry practice in West Palm Beach, Florida. Dr. Jasper is a Benedict Professor in practice management at Houston College of Optometry and a community leader. Dr. Jasper is also Chief Optometric Editor of Optometric Management magazine, a fellow of the American Academy of Optometry and Past-President of the Florida Optometric Association. Dr. Jasper received her degree in Optometry from Nova Southeastern University and completed her residency in primary care, ocular disease and contact lenses in Boston, Massachusetts where she also held a position as adjunct professor at the New England College of Optometry.
About EyenoviaEyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print delivery technology. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information please visit www.eyenovia.com.
About MicroLine for PresbyopiaMicroLine is Eyenovia’s pharmacologic treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the company’s high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability and usability.
Upcoming Milestone: Initiate and Complete Phase III VISION Trials in 2020
About MicroPine for Progressive MyopiaMicroPine (atropine ophthalmic solution) is Eyenovia's first-in-class topical treatment for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness. Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment. MicroPine has been developed for comfort and ease-of-use in children. Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).
Feasibility Dose-finding Atropine Studies: ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials)
Upcoming Milestone: Complete Enrollment of the Phase III CHAPERONE Study in 2020
About MicroStat for MydriasisMicroStat is Eyenovia's first-in-class fixed-combination micro-formulation product (phenylephrine 2.5% -tropicamide 1%) candidate for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive and diabetic eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed for use without anesthetic, we are developing MicroStat to improve the efficacy and tolerability of pharmacologic mydriasis.
Upcoming Milestone: File NDA in 2020
About Optejet™ and MicroRx Ocular TherapeuticsEyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet is less than 75% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
Forward Looking StatementsExcept for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities in the United States for our product candidates. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the SEC. In addition, such statements could be affected by risks and uncertainties related to, among other things: our ability to attract and retain key members of our company; fluctuations in our financial results; the potential success of our reprioritized pipeline; any cost savings related to our reprioritized pipeline; our ability to identify new product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; risks involved in clinical trials, including, but not limited to, the design, initiation, timing, progress and results of such trials; the timing and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our ability to timely develop and implement manufacturing, commercialization and marketing capabilities and strategies for existing product candidates; our ability to raise money; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statements.
Company Contact:Eyenovia, Inc.John GandolfoChief Financial Officerjgandolfo@eyenoviabio.com
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