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Eyenovia Advances User-Filled Optejet Toward Market with Strong Safety and Dosing Results

Benzinga·04/10/2025 11:08:23
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Eyenovia, Inc. (NASDAQ:EYEN) ("Eyenovia" or the "Company"), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today provided an update on recent progress made in the development of the Company's novel Optejet UFD. The user-filled Optejet is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting products, spanning multiple billion-dollar markets.

Eyenovia continues to advance the Optejet UFD through Verification & Validation (V&V) studies to ensure that the device meets the standards around intended use and customer requirements. As of today, the Company has completed the following parameters:

  • Physical requirements such as dimensions and weight, and presence and operation of various light indicators
  • Usability requirements identified, including forces required to actuate the device or connect and disconnect the cartridge
  • Dosing performance, with consistency in delivering ophthalmic liquids to within a standard deviation of 1 microliter.
  • Longevity testing demonstrating that the device can operate without failure for the intended life span and with a sufficient safety factor.
    • In particular, tested key components more than 30,000 times, and demonstrated that the device can precisely dispense the ophthalmic solution well beyond 30,000 actuations.
  • Safety testing of the base according to recognized standards, such as IEC 60601, to ensure performance specifications are met. This testing includes, among other things, electromagnetic interference, compatibility, and electrostatic discharge testing.
    • The Optejet UFD has satisfactorily met all requirements.
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