Presentation to highlight recent FDA approval of Mydcombi™ for mydriasis which leverages Eyenovia’s novel Optejet dispensing device
Optejet represents the first true advancement in the topical administration of ophthalmic medications in more than 100 years
NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the company will be delivering a presentation at the annual OCTANE Ophthalmology Tech Forum 2023, which is being held June 8-9 in Newport Beach, CA.
The presentation is scheduled for Friday, June 9th at 5:00 p.m. PDT.
Norbert Lowe, Eyenovia’s Vice President of Commercial Operations, will present on the recent FDA approval of Mydcombi, the first and only FDA-approved tropicamide and phenylephrine ophthalmic spray for mydriasis, and the first of what is planned as a series of unique products based on Eyenovia’s proprietary Optejet dispenser.
“The theme of this year’s OCTANE forum, ‘Future Focused,’ will highlight recent innovations that will shape the future of ophthalmology, and we believe our novel Optejet technology will do just that,” stated Michael Rowe, chief executive officer of Eyenovia. “The recent approval of Mydcombi for mydriasis was an important achievement for Eyenovia as it provided critical validation of the Optejet, which is the foundation of not only our own development programs, but also our existing and future partnerships and collaborations as well.
“The Optejet represents the first true advancement in the administration of topical ophthalmic medications since the invention of eyedrops over 100 years ago, and we are pleased to highlight this innovation to the many peers, practitioners, thought leaders and investors at this year’s OCTANE conference,” Mr. Rowe concluded.
For more information: https://octaneoc.org/ophthalmology-tech-forum/
IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
INDICATIONS
MYDCOMBI is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired
CONTRAINDICATIONS: In patients with known hypersensitivity to any component of the formulation
WARNINGS AND PRECAUTIONS
Not for Injection: Topical ophthalmic use
Significant Elevations in Blood Pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment.
Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported.
Intraocular Pressure: May produce a transient elevation
Rebound Miosis: Reported 1 day after administration
ADVERSE REACTIONS
- Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics.
- Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)
Please go to www.mydcombi.com for FULL PRESCRIBING INFORMATION
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications in the Optejet device for presbyopia and myopia progression. For more information, visit Eyenovia.com.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this presentation 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 for our product candidates and platform technology. 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 in some cases 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 U.S. Securities and Exchange Commission.
In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential advantages of our product candidates and platform technology; 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; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical 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, Eyenovia does not undertake any obligation to update any forward-looking statements.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com
