Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

Next Previous
Search
Trial Profile

A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2023

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Phenylephrine/tropicamide (Primary)
  • Indications Mydriasis
  • Focus Diagnostic use; Registrational
  • Acronyms MIST-2
  • Sponsors Eyenovia

    • Most Recent Events

    • 01 Jun 2023 Accoding to an Eyenovia media release, Norbert Lowe, Eyenovia's Vice President of Commercial Operations, will present highlights on recent FDA approval of Mydcombi at the annual OCTANE Ophthalmology Tech Forum 2023, which is scheduled for Friday, June 9th at 5:00 p.m. PDT in Newport Beach, CA.
    • 13 Dec 2022 Accoding to an Eyenovia media release, the company is currently not planning to hold an advisory committee meeting to discuss the application.
    • 13 Dec 2022 Accoding to an Eyenovia media release, the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MydCombi™ ophthalmic spray. NDA is supported by MIST-1 trial (NCT03751631) and MIST-2 (NCT03751098) trials. Prescription Drug User Fee Act (PDUFA) target action date is May 8, 2023.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top