UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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| Item 7.01 | Regulation FD Disclosure. |
On February 12, 2021, Ocular Therapeutix, Inc. (the “Company”) announced its intention to present interim data from its Phase 1 clinical trial of OTX-TKI, an axitinib intravitreal implant for the treatment of patients with wet age-related macular degeneration and other retinal diseases, at the upcoming Angiogenesis, Exudations, and Degeneration 2021 Meeting to be held virtually on February 12 and February 13, 2021. Certain information to be provided during such presentation is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits: |
| 99.1 | Certain slides to be presented at Angiogenesis, Exudation and Degeneration 2021 Meeting, dated February 13, 2021 | |
| 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.
| OCULAR THERAPEUTIX, INC. | ||
| Date: February 12, 2021 | By: | /s/ Donald Notman |
| Donald Notman | ||
| Chief Financial Officer | ||
Exhibit 99.1
Cohort 1: n=6 until Month 9; Cohort 2: n=7 until Month 9; n=6 for Month 11; n=6 for Month 12; n=4 for Month 14 Cohort 3a: n=5 until Month 1; n=3 for Month 2; n=2 for Month 3; n=1 for Month 4.5 & 6; Cohort 3b: n=2 until Month 2; n=1 unti l M onth 3 *All BCVA and CSFT values compared to Baseline visit; NOTE: Interim review, unmonitored data; Data cut on January 29, 2021 Change from Baseline in BCVA Change from Baseline in CSFT -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 Mean Change from Baseline in BCVA (ETDRS letters) “ SEM Cohort 1 (200 µg) Cohort 2 (400 µg) Cohort 3a (600 µg) Cohort 3b (400 µg + Anti-VEGF) All Cohorts: Mean Change in CSFT and BCVA -450 -350 -250 -150 -50 50 150 250 Mean Change from Baseline in CSFT (µm) “ SEM Cohort 1 (200 µg) Cohort 2 (400 µg) Cohort 3a (600 µg) Cohort 3b (400 µg + Anti-VEGF)
Duration of Effect Percentage of Subjects Without Needing Rescue Medications Cohorts At 3 months % (n/N) At 6 months % (n/N) At 7.5 months % (n/N) At 9 months % (n/N) At 11 months % (n/N) At 13.5 months % (n/N) Cohort 1 (200 µg) 66.7 (4/6) 50 (3/6) 50 (3/6) 50 (3/6) NA NA Cohort 2 (400 µg)* 71.4 (5/7) 57.1 (4/7) 42.9 (3/7) 42.9 (3/7) 33.3 (2/6)* 25 (1/4)* Cohort 3a (600 μ g)* 100 (2/2) 100 (1/1) TBD TBD TBD TBD Cohort 3b (400 μ g + anti - VEGF)* 100 (1/1) TBD TBD TBD TBD TBD NOTE: Interim review, unmonitored data; Data cut on January 29, 2021 *Follow - up ongoing Extended Follow - up