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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 13, 2022

 

 

EYENOVIA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware   001-38365   47-1178401
(State or other jurisdiction
of incorporation)  		   (Commission
 File Number) 		  (IRS Employer
 Identification No.)  

 

295 Madison Avenue, Suite 2400, New York, NY 10017

(Address of Principal Executive Offices, and Zip Code)

 

(917) 289-1117

Registrant’s Telephone Number, Including Area Code 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

(Title of each class)   (Trading
Symbol)  		   (Name of each exchange
on which registered)  
Common stock, $0.0001 par value   EYEN   The Nasdaq Stock Market
 (Nasdaq Capital Market)  

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

  

Item 8.01. Other Events.

 

On December 13, 2022, Eyenovia, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has accepted for review the Company’s New Drug Application for MydCombi, the Company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office-pupil dilation.

 

A copy of the press release is filed hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits  
     
  Exhibit No. Description
     
  99.1 Eyenovia, Inc. Press Release dated December 13, 2022.
     
  104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

  EYENOVIA, INC.
   
Date: December 13, 2022 /s/ John Gandolfo
  John Gandolfo
  Chief Financial Officer

 

 

 

 

 

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