{"id":755864,"date":"2023-05-08T08:06:42","date_gmt":"2023-05-08T12:06:42","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/eyenovia-announces-fda-approval-of-mydcombi-the-first-ophthalmic-spray-for-mydriasis-which-also-leverages-the-companys-proprietary-optejet-device-platform\/"},"modified":"2023-05-08T08:06:42","modified_gmt":"2023-05-08T12:06:42","slug":"eyenovia-announces-fda-approval-of-mydcombi-the-first-ophthalmic-spray-for-mydriasis-which-also-leverages-the-companys-proprietary-optejet-device-platform","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/eyenovia-announces-fda-approval-of-mydcombi-the-first-ophthalmic-spray-for-mydriasis-which-also-leverages-the-companys-proprietary-optejet-device-platform\/","title":{"rendered":"Eyenovia Announces FDA Approval of Mydcombi\u2122, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company\u2019s Proprietary Optejet\u00ae Device Platform"},"content":{"rendered":"
\n

\n Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis<\/em>
\n \n <\/p>\n

\n Provides critical validation of key technology that is core to Eyenovia\u2019s proprietary development programs as well as current and future partnerships<\/em>\n <\/p>\n

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) — Eyenovia, Inc.<\/a> (NASDAQ: EYEN),\u00a0an ophthalmic technology company developing the Optejet\u00ae 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 U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%\/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia\u2019s proprietary Optejet device to be approved by any regulatory authority.<\/p>\n

Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.<\/p>\n

\u201cThe approval of Mydcombi, our first FDA approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,\u201d stated Michael Rowe, chief executive officer of Eyenovia. \u201cWe look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.\u201d<\/p>\n

\u201cPerhaps more importantly, FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to our internal development programs, including MicroLine for presbyopia, but our partnered programs as well. We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye. I am confident in our ability to maintain our current momentum.\u201d<\/p>\n

\u201cI am proud of our team for this significant achievement \u2013 which represents many \u2018firsts\u2019 for eye care,\u201d stated Dr. Sean Ianchulev, Founder and Chairman of Eyenovia\u2019s Board of Directors. \u201cThe use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.\u201d<\/p>\n

Eyenovia management will provide additional updates on Mydcombi as well as its ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference call and webcast on May 11th<\/sup>, 2023.<\/p>\n

\n IMPORTANT SAFETY INFORMATION for MYDCOMBI<\/strong>
\n \u2122<\/strong>
\n \u00a0(tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%\/2.5%<\/strong>\n <\/p>\n

\n INDICATIONS<\/strong>\n <\/p>\n

MYDCOMBI is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired<\/p>\n

\n CONTRAINDICATIONS:\u00a0<\/strong>In patients with\u00a0known hypersensitivity to any component of the formulation<\/p>\n

\n WARNINGS AND PRECAUTIONS<\/strong>\n <\/p>\n

\n Not for Injection: <\/strong>Topical ophthalmic use<\/p>\n

\n Significant Elevations in Blood Pressure:\u00a0<\/strong>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.<\/p>\n

\n Central Nervous System Disturbances:<\/strong>\u00a0Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported.<\/p>\n

\n Intraocular Pressure:\u00a0<\/strong>May produce a transient elevation<\/p>\n

\n Rebound Miosis:\u00a0<\/strong>Reported 1 day after administration<\/p>\n

\n ADVERSE REACTIONS<\/strong>\n <\/p>\n