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 |
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001-36554 |
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20-5560161 |
(State or Other Jurisdiction |
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(Commission |
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(IRS Employer |
15 Crosby Drive
Bedford, MA 01730
(Address of Principal Executive Offices) (Zip Code)
Companys 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 |
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Trading Symbol(s) |
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Name of exchange on which registered |
Common Stock, $0.0001 par value per share |
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OCUL |
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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 Companys 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 |
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Description |
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99.1 |
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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.
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OCULAR THERAPEUTIX, INC. | |
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Date: June 6, 2019 |
By: |
/s/ Donald Notman |
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Donald Notman |
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Chief Financial Officer |
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
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