US-based Eyenovia, Inc. (NASDAQ: EYEN) has announced obtaining market approval from the US Food and Drug Administration (FDA) for its Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%. This product is indicated for inducing mydriasis during diagnostic procedures and in conditions requiring short-term pupil dilation.
A Milestone in Ophthalmic Drug Delivery
This approval marks the first time a fixed dose combination of tropicamide and phenylephrine has been approved in the United States. Additionally, it is the first product using Eyenovia’s proprietary Optejet device to gain regulatory approval. This Optejet device employs Eyenovia’s Micro Array Print (MAP) technology, which allows for the precise and rapid delivery of mydriatic drugs to the ocular surface in the form of micro-droplets, offering a simple, safe, and easy operation.
Arctic Vision Expands Licensing Agreement with Eyenovia
In September 2021, China-based ophthalmology specialist Arctic Vision expanded its licensing agreement with Eyenovia, securing exclusive development and commercialization rights to MydCombi in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, as well as South Korea. This agreement builds on the existing partnership for two other Eyenovia products: MicroPine, a treatment for progressive myopia, and MicroLine, a treatment for presbyopia.-Fineline Info & Tech
