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Eyenovia, Inc. (NASDAQ: EYEN) is a pioneering biopharmaceutical company specializing in the development and commercialization of next-generation topical eye treatments. Utilizing its proprietary Microdose Array Print (MAP) platform technology, Eyenovia is at the forefront of transforming ophthalmic care through precision-targeted ocular delivery systems.
The company’s flagship technology, branded as Optejet, aims to revolutionize the delivery of ophthalmic medications. This high-precision device offers a significant improvement over conventional eye droppers by ensuring better safety, tolerability, and patient compliance. The Optejet technology is designed to enhance the delivery success of both novel and existing pharmaceutical agents, making it a versatile tool for a wide range of eye conditions.
Eyenovia's current focus includes the commercialization of Mydcombi™ (a combination of tropicamide and phenylephrine ophthalmic spray) for mydriasis and the newly FDA-approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for post-operative inflammation and pain relief following ocular surgery. The company also boasts a promising pipeline, with late-stage development projects such as MicroPine for myopia progression and Apersure for presbyopia, both leveraging the Optejet delivery system.
Recent achievements highlight Eyenovia’s innovative prowess. The FDA's approval of clobetasol propionate ophthalmic suspension 0.05%, a first in over 15 years for new ophthalmic steroids, underscores the company’s commitment to bringing groundbreaking therapies to market. This novel formulation, which leverages Formosa Pharmaceuticals' APNT™ nanoparticle technology, has shown superior efficacy in reducing post-operative inflammation and pain, positioning it to capture a significant share of the $1.3 billion annual market for topical ophthalmic steroids.
Eyenovia's strategic collaborations further enhance its capabilities. The company has partnered with Arctic Vision for the development of MicroPine in China and South Korea, and with major players like Formosa Pharmaceuticals and AimMax Therapeutics to advance its product offerings. These collaborations reflect Eyenovia’s strategic approach to global market penetration and its commitment to addressing critical unmet needs in ophthalmic care.
The company continues to engage with the ophthalmic community through active participation in medical and commercial meetings such as ASCRS and Vision Source Exchange. These platforms allow Eyenovia to demonstrate its full suite of commercial products, including Mydcombi and Avenova, while establishing itself as the partner of choice for leading ophthalmic and optometric practices.
As Eyenovia progresses towards its commercialization goals, it remains focused on strategic alternatives to maximize shareholder value, including potential mergers, acquisitions, or partnerships. The company's commitment to innovative eye care solutions, patient-centric product development, and robust commercialization strategies positions it well for future growth and industry leadership.
For more detailed information, visit the Eyenovia corporate website or its investor relations page.
Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company, announced a poster presentation at the ARVO 2023 meeting on April 25, showcasing their Optejet technology for delivering the anti-glaucoma medication latanoprost.
CEO Michael Rowe highlighted that the Optejet achieves therapeutic dosing with lesser exposure to harmful preservatives compared to conventional eye drops. The upcoming PDUFA date on May 8 for Mydcombi, a mydriasis agent, is crucial as it could validate the Optejet technology.
The study demonstrated Optejet via Micro-Array Print (MAP) reduces ocular surface stress and is associated with lower cell toxicity and inflammatory responses compared to traditional methods.
Eyenovia, Inc. (Nasdaq: EYEN) announced FDA acceptance of its Mydcombi New Drug Application (NDA) with a PDUFA action date set for May 8, 2023. The company reported positive results from the Microline Phase 3 program for presbyopia, receiving supportive FDA feedback. A partnership was formed with Formosa Pharmaceuticals for co-development, aiming to enhance ophthalmic treatments. Financially, the Q4 2022 net loss was approximately $6.1 million ($0.17 per share), contrasting with a net income of $3.0 million in Q4 2021. Total cash and cash equivalents at year-end 2022 were approximately $22.9 million, down from $27.3 million in 2021.
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