Eyenovia Inc. – an ophthalmic technology firm setting up the Optejet equipment for use in conjunction with its own medication-device therapeutic product candidates for cataracts and pediatric progressive myopia and through out-licensing for further indications – has announced that the U.S. Food and Drug Administration (FDA) has granted approval to Mydcombi for triggering mydriasis for diagnostic purposes and in circumstances in which brief dilation of the pupils is desired.
Mydcombi was classified as a medication-device combination product by the country’s health authorities in 2021. This was due to the fact that the drug could only be administered through the use of Eyenovia’s experimental Optejet drug delivery system.
In the U.S., this is the first time that a fixed dosage combination of tropicamide and phenylephrine has been given the go-ahead, and it is also the first time that a product that uses Eyenovia’s unique Optejet technology has been given approval by any regulatory body.
Mydcombi is intended to enhance the effectiveness of the over 106 million office-based holistic eye exams that are conducted annually in the country, as well as the approximately 4 million pharmaceutical mydriasis forms for cataract surgery. These two types of eye tests are performed annually in the U.S. Individuals who have an allergy to any of the formulation’s components should not use this product since it is contraindicated.
The regulatory body had previously decided not to grant approval for the spray in its previous iteration as a stand-alone medication and had sought more device testing for the Optejet dispenser. The FDA has not asked for any more clinical testing to be done on the Mydcombi drug.
Michael Rowe, the CEO of Eyenovia, was understandably delighted with the approval. Expressing his gratitude to all the stakeholders involved in helping Mydocombi achieve the milestone, he said that it wouldn’t have been possible without the tireless efforts of the Eyenovia team. He added that the company is excited to introduce the drug to important offices very soon, while taking its production capabilities to the next level.
“Perhaps 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”.
The company will provide further updates on Mydcombi, along with its ongoing development programs, in the coming week.
The drug should be used with caution in individuals with cardiovascular disease or hyperthyroidism, as well as in children younger than 5 years of age. After treatment, blood pressure should be monitored for high-risk individuals.
The drug also has some reported adverse reactions that individuals should be mindful of. Temporary vision loss, decreased clarity of vision, photophobia, superficial punctate keratitis, and moderate eye pain are the most commonly reported ones. The use of mydriatics has also been linked to elevated intraocular pressure.