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): June 6, 2019

 

OCULAR THERAPEUTIX, INC.

(Exact Name of Company as Specified in Charter)

 

Delaware

 

001-36554

 

20-5560161

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

15 Crosby Drive

Bedford, MA 01730

(Address of Principal Executive Offices) (Zip Code)

 

Company’s telephone number, including area code: (781) 357-4000

 

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 (see General Instruction A.2. below):

 

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

 

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

 

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

 

o            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(s)

 

Name of exchange on which registered

Common Stock, $0.0001 par value per share

 

OCUL

 

The Nasdaq Global Select Market

 

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

 

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.    x

 

 

 


 

Item 8.01. Other Events.

 

On June 6, 2019, Ocular Therapeutix, Inc. (the “Company”) will be attending the Jefferies 2019 Global Healthcare Conference and presenting data from the Company’s first pivotal Phase 3 clinical trial of OTX-TP, an intracanalicular insert that delivers a preservative-free formulation of the drug travoprost for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.  The Company previously announced topline results from this Phase 3 clinical trial on May 20, 2019.  Excerpts from the presentation containing the data from the Phase 3 clinical trial are included in Exhibit 99.1 attached hereto and are incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)                                 Exhibits.

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Excerpts from Company presentation, dated June 6, 2019.

 

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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.

 

 

OCULAR THERAPEUTIX, INC.

 

 

 

Date: June 6, 2019

By:

/s/ Donald Notman

 

 

Donald Notman

 

 

Chief Financial Officer

 

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Exhibit 99.1

 

OTX-TP PHASE 3 TRIAL: Topline Efficacy results Mean intraocular pressure Diurnal Timepoints 2 Weeks 6 Weeks 12 Weeks OTX-TP mm Hg Placebo mm Hg LS Mean P-value OTX-TP mm Hg Placebo mm Hg LS Mean P-value OTX-TP mm Hg Placebo mm Hg LS Mean P-value 8:00 AM 21.02 22.86 <.0001 21.93 22.73 0.0181 22.83 23.23 0.2521 10:00 AM 20.16 21.92 <.0001 21.05 21.85 0.0077 21.74 22.45 0.0234 4:00 PM 19.46 21.51 <.0001 20.53 21.55 0.0004 21.41 22.08 0.0310 15 Full Analysis Set, Baseline-adjusted Least Squared (LS) Means

GRAPHIC

 

OTX-TP PHASE 3 TRIAL: Topline Efficacy results Reduction in intraocular pressure (change from baseline) Diurnal Timepoints 2 Weeks 6 Weeks 12 Weeks OTX-TP mm Hg Placebo mm Hg LS Mean P-value OTX-TP mm Hg Placebo mm Hg LS Mean P-value OTX-TP mm Hg Placebo mm Hg LS Mean P-value 8:00 AM -5.72 -3.88 <.0001 -4.81 -4.01 0.0181 -3.91 -3.52 0.2521 10:00 AM -4.92 -3.16 <.0001 -4.03 -3.23 0.0077 -3.34 -2.63 0.0234 4:00 PM -5.22 -3.18 <.0001 -4.16 -3.14 0.0004 -3.27 -2.60 0.0310 16 Full Analysis Set, Baseline-adjusted Least Squared (LS) Means

GRAPHIC