Eyenovia宣布Mydcombi的首次商业销售

Represents the first FDA approved and commercially available fixed combination of tropicamide and phenylephrine for pupil dilation
 

Validates Eyenovia's proprietary Optejet® dispensing platform

World-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe becomes first to incorporate Mydcombi into his daily practice

NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and 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 the first commercial sale of Mydcombi. Mydcombi was approved by the US Food and Drug Administration on May 8, 2023. The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.

"We are very pleased to initiate sales of Mydcombi to select professional offices so that ophthalmologists, optometrists, technicians and their patients can experience the benefits of Mydcombi's metered spray delivery relative to conventional multiple eye drops," stated Michael Rowe, chief executive officer of Eyenovia. "We have now kicked off our targeted launch while we continue to ramp up our internal manufacturing capabilities."

"I have been eagerly awaiting the commercial availability of Mydcombi to provide a great experience to my patients who require pupil dilation," stated Dr. Radcliffe. "In addition, given the potential for streamlining patient throughput that Mydcombi may facilitate, I anticipate that it will be the go-to mydriasis agent in my own practice going forward."

Mydcombi is designed to streamline the estimated 106 million office-based comprehensive eye exams with pupil dilation performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for ocular surgery. In clinical studies, Mydcombi was statistically superior to tropicamide and to phenylephrine administered alone, with effective pupil dilation in almost two thirds of patients seen as early as 20 minutes after application, with excellent tolerability. The product should not be used in patients with known hypersensitivity to any component of the formulation.

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

FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION

This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Significant elevations in blood pressure have been reported. Caution in patients with elevated blood pressure.

Rebound miosis has been reported one day after installation.

Remove contact lenses before using.

DRUG INTERACTIONS

Atropine-like Drugs: May exaggerate the adrenergic pressor response

Cholinergic Agonists and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors

Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents

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