FDA to require only one late-stage study to support marketing application for Eyenovia's MicroPine for myopia; shares up 2% [Seeking Alpha]
Eyenovia, Inc. (EYEN)
Last eyenovia, inc. earnings: 3/25 04:05 pm
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Source: Seeking Alpha
FDA to require only one late-stage study to support marketing application for Eyenovia's MicroPine for myopia; shares up 2%Eyenovia (EYEN+1.7%)announces that the FDA has indicated that only one pivotal Phase 3 clinical trial evaluating MicroPine for the treatment of myopia (nearsightedness) will be required to support a U.S. marketing application. The agency has also provided clarity on the design of the study, expected to launch about mid-2019.MicroPine is a micro-therapeutic formulation ofatropine, an anticholinergic agent (inhibits acetylcholine) used historically to treat certain types of poisoning, life-threatening low heart rate, stomach/intestinal spasms and to reduce mucus and other body secretions.See all stocks on the move »Now read:Eyenovia Finalizes $30 Million U.S. IPO Terms »
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News
- Eyenovia (EYEN) Down 18% on Disappointing Corporate Update [Yahoo! Finance]Yahoo! Finance
- Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities [Yahoo! Finance]Yahoo! Finance
- Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial OpportunitiesGlobeNewswire
- Eyenovia to Feature its Suite of Commercial Products and the Optejet Dispenser at Upcoming National Eyecare Meetings [Yahoo! Finance]Yahoo! Finance
- Eyenovia to Feature its Suite of Commercial Products and the Optejet Dispenser at Upcoming National Eyecare MeetingsGlobeNewswire
EYEN
Earnings
- 3/18/24 - Miss
EYEN
Sec Filings
- 4/23/24 - Form PRE
- 4/10/24 - Form 8-K
- 4/10/24 - Form 424B5
- EYEN's page on the SEC website