Ocular Therapeutix, Inc 8-K, filed Jun 12, 2023
Ocular Therapeutix, Inc (OCUL)
About this 8-K
Ocular Therapeutix, Inc filed this 8-K on June 12, 2023, reporting on events of June 10, 2023.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On June 10, 2023, Ocular Therapeutix, Inc. (the “Company”) announced 12-month data from its Phase 1 U.S.-based clinical trial evaluating OTX-TKI for the treatment of wet age-related macular degeneration (“wet AMD”). An excerpt from the presentation of the 12-month data is included as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
An investigational, bioresorbable hydrogel intravitreal implant, OTX-TKI is designed to continuously deliver a potent tyrosine kinase inhibitor, axitinib, for the treatment of wet AMD, diabetic retinopathy and other VEGF-mediated retinal diseases. The U.S.-based Phase 1 clinical trial is a prospective, multi-center, randomized, controlled study in subjects previously treated with anti-VEGF therapy that is evaluating a 600 μg dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant, compared to 2 mg aflibercept injections administered every 8 weeks. The trial is designed to assess the safety, durability and tolerability of OTX-TKI, and to assess biological activity in subjects by measuring best corrected visual acuity (“BCVA”) and central subfield thickness (“CSFT”) of the retina.
The clinical trial enrolled a total of 21 subjects at six clinical sites in the United States, who were randomized 3:1 to an arm receiving a single OTX-TKI implant, with a 2 mg aflibercept injection four weeks after implant injection, and an arm receiving aflibercept injections every 8 weeks. One subject in the OTX-TKI arm was not treated per protocol and has been removed from the efficacy analysis, as the subject incorrectly received aflibercept instead of a sham injection at Month 3 and 5 visits.
The 12-month data demonstrated maintenance of controlled wet AMD subjects comparable to aflibercept injections every eight weeks with a single administration of OTX-TKI. Four subjects received rescue therapy for the first time at Month 12, indicating the waning of OTX-TKI’s therapeutic effect and potential disease reactivation, which helps establish a re-dosing timeline for patients.
The results showed subjects treated with a single OTX-TKI implant continued to demonstrate sustained BCVA (mean change from baseline of -1.0 letters) and CSFT (mean change from baseline of +20.2 μm) in the OTX-TKI arm at 12 months, which was comparable with the aflibercept arm (mean change from BCVA baseline of +2.0 letters; mean change from CSFT baseline of -2.2 μm). 60% of OTX-TKI subjects were rescue-free up to Month 12. At the Month 12 visit, an additional four of the subjects were rescued. Overall, an 89% reduction in treatment burden was observed in OTX-TKI treated subjects at 12 months.
As of the data cutoff of April 14, 2023, there were no drug-related ocular or systemic serious adverse events (“SAEs”) observed in the OTX-TKI arm. As the Company previously announced at the 10-month data readout, one SAE of endophthalmitis was observed in the OTK-TKI arm, which occurred following the mandated aflibercept injection at Month 1 and was assessed by the investigator as related to the injection procedure. There were no retinal detachment, retinal vasculitis, or implant migration into the anterior chamber adverse events observed in the OTX-TKI arm, and no subjects had dropped out of either arm as of the data cutoff.
The Company is prepared to initiate a pivotal trial in wet AMD as early as the third quarter of 2023, subject to obtaining the necessary financing, which could be provided through a strategic alliance.
As previously announced, the Company also recently completed enrollment of its Phase 1 HELIOS clinical trial to evaluate OTX-TKI for the treatment of diabetic retinopathy. The Company expects to report 6-month interim results for the HELIOS trial in the first quarter of 2024.
Cautionary Note on Forward Looking Statements
Any statements in this Current Report on Form 8-K about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA® or any of the Company’s products or product candidates; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and the timing of planned pivotal clinical trials for OTX-TKI for the treatment of retinal diseases including wet AMD and diabetic retinopathy; the Company’s plans to advance the development of OTX-TKI; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the potential utility of any of the Company’s product candidates; the size of the potential market for OTX-TKI; the Company’s ability to fund the planned and future clinical development of its product candidates whether through strategic alliances or other fundraising; the Company’s ability to enter into and perform its obligations under collaborations; the sufficiency of the Company’s cash resources; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval, the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, whether interim clinical trial data such as the data reported in this Current Report on Form 8-K will be indicative of the results of the trial upon its completion or subsequent clinical trials in this and other indications, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all, the Company’s ability to recruit and retain key personnel, and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this Current Report on Form 8-K represent the Company’s views as of the date of this Current Report on Form 8-K. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits: |
| 99.1 | Excerpt from presentation of data from Phase 1 clinical trial on June 10, 2023 |
| 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: June 12, 2023 | By: | /s/ Donald Notman |
| Donald Notman | ||
| Chief Financial Officer | ||
Exhibit 99.1
Month 10 Analysis (Presented at Angiogenesis 2023) Month 7 Analysis (Presented at AAO 2022) 1 OTX - TKI U.S. - based Wet AMD Clinical Trial Design OTX - TKI Arm Aflibercept Arm OTX - TKI 600µg single implant injection Aflibercept 2mg injection Sham injection Study Visit Multicenter, Randomized, Double - masked Trial Screening Key Inclusion Criteria ▪ Sub foveal neovascularization secondary to AMD ▪ Controlled fluid ▪ Previously treated with anti - VEGF injections Rescue Anti - VEGF Injection Criteria: ▪ Loss of ≥10 letters from best previous BCVA with current BCVA worse than baseline, or ▪ Evidence of ≥75µm CSFT increase from previous best value and ≥5 letters loss from best previous BCVA, or ▪ New macular hemorrhage Baseline Month 12 Analysis 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Study Visits (Weeks) AAO=American Academy of Ophthalmology; AMD=age - related macular degeneration; BCVA=best corrected visual acuity; BL=baseline; CSF T=central subfield thickness; AMD=age - related macular degeneration; VEGF=vascular endothelial growth factor OTX - TKI subjects are followed past Week 52 Randomization 3:1 (OTX - TKI : Aflibercept) R
2 Baseline Characteristics Baseline Characteristic OTX - TKI (N=16) † Aflibercept (N=5) Mean (SD) Age, Years 76 (8) 84 (8) Male, n (%) Female, n (%) 8 (50) 8 (50) 3 (60) 2 (40) Mean (SD) Months since wet AMD diagnosis 18 (12) 18 (12) Mean (SD) Number of anti - VEGF Injections within 12 Months Prior to baseline* 8 (3) 8 (4) Mean (SD) BCVA in ETDRS Letters 70.9 (17.7) 73.8 (9.0) Mean (SD) CSFT, µm 273.8 (43.0) 240.6 (29.6) *Annualized data † Includes one subject not treated per protocol who has been removed from efficacy analysis as subject incorrectly received afl ibe rcept instead of sham injection at Month 3 and 5 visits Data cut off April 14, 2023 BCVA=best corrected visual acuity; CSFT =c entral subfield thickness; ETDRS = Early Treatment Diabetic Retinopathy Study; AMD = age - related macular degeneration; SD = standard deviation; VEGF = vascular endothelial growth factor
-52 -48 -44 -40 -36 -32 -28 -24 -20 -16 -12 -8 -4 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Weeks OTX - TKI (n=15) Aflibercept (n=5) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Reduction in Anti - VEGF Injections Following OTX - TKI at 12 Months 89% reduction in treatment burden with OTX - TKI at 12 months Ranibizumab Faricimab OTX - TKI 600µg implant Unspecified anti - VEGF agent Bevacizumab Rescue injection given at investigator’s discretion (rescue criteria not met ) Post - Treatment Pre - Treatment 3 Data cut off April 14, 2023; per protocol analysis Reduction in treatment burden calculation includes all rescue injections Sham injection was given at Week 0 in the Aflibercept Arm and at Weeks 12, 20, 28, 36 and 44 in the OTX - TKI Arm (not shown). At Week 52, subjects in the aflibercept group were treated with wet AMD standard of care at the investigator’s discretion. Rescue injection given (rescue criteria met ) Aflibercept
100% 100% 93% 93% 80% 73% 73% 73% 73% 67% 67% 60% 0% 20% 40% 60% 80% 100% Percentage of OTX - TKI Subjects Rescue - Free Up to Each Visit (n=15) 4 OTX - TKI Demonstrated Extended Duration of Action 60% were rescue - free up to 12 months with 4 additional subjects rescued at 12 months Data cut off April 14, 2023 Rescue - free rate calculations: If subjects received rescue anti - VEGF therapy at a study visit, those were reflected to count at the following study visit in the graph above Percentages presented in the graph above represent rescue - free rates up to each study visit, except for the 33% at Week 52 which includes rescue injections given at the Week 52 study visit 15/15 14/15 14/15 12/15 11/15 11/15 11/15 15/15 11/15 Rescue - free Subjects, n/N 10/15 9/15 10/15 Week 8 Week 12 Week 16 Week 20 Week 24 Week 28 Week 32 Week 36 Week 40 Week 44 Week 48 Week 52 33% inclusive of Week 52 Implant bioresorbs ~8 - 9 months
5 Vision and CSFT with OTX - TKI were Comparable to Aflibercept Q8W -70 -50 -30 -10 10 30 50 70 BL W4 W8 W12 W16 W20 W24 W28 W32 W36 W40 W44 W48 W52 Mean CSFT Change from Baseline, µm Mean Change in CSFT -15 -10 -5 0 5 10 15 BL W4 W8 W12 W16 W20 W24 W28 W32 W36 W40 W44 W48 W52 Mean BCVA Change from Baseline, ETDRS Letters Mean Change in BCVA Aflibercept Q8W (n=5) OTX-TKI (censoring rescued subjects)* OTX-TKI (n=15) Mean baseline CSFT OTX - TKI: 269.2 (40.3) µm Aflibercept Q8W: 240.6 (29.6) µm Mean baseline BCVA OTX - TKI: 73.7 (14.4) letters Aflibercept Q8W: 73.8 (9.0) letters Mean (SD) change in BCVA from baseline to Week 52: D ata cut off April 14, 2023 Error bars represent standard deviation; n=14 in OTX - TKI arm at Weeks 8, 28, 40 and 48 due to missed visits *Sample size for OTX - TKI (censoring rescued subjects): n=15 at Baseline and Weeks 4 and 12; n=14 at Week 8 (missed visit) and We eks 16 and 20; n=12 at Week 24 and n=11 at Weeks 28, 32, 36 and 40; n=10 at Week 44; n=9 at Weeks 48 and 52 BCVA=best corrected visual acuity; BL=baseline; CSFT=central subfield thickness; ETDRS=Early Treatment Diabetic Retinopathy S tud y; W, week OTX - TKI: - 1.0 (6.0) letters Aflibercept Q8W: +2.0 (7.2) letters OTX - TKI: +0.6 (2.6) letters (censoring rescued subjects) Mean (SD) change in CSFT from baseline to Week 52: OTX - TKI: +20.2 (41.6) µm Aflibercept Q8W: - 2.2 (8.5) µm OTX - TKI: +17.2 (47.6) µm (censoring rescued subjects)
6 Safety Summary OTX - TKI n=16 Aflibercept n=5 Subjects with Adverse Events in the Study Eye, n (%) Elevated IOP 2 (12.5) 1 (20.0)** Retinal detachment 0 0 Retinal vasculitis 0 0 Implant migration into the anterior chamber 0 NA Acute endophthalmitis 1 (6.25)* 0 Subjects with Ocular Adverse Events in the Study Eye Reported by Severity, n (%) Ocular AEs 16 (100.0) 3 (60.0) Mild 14 (87.5) 2 (40.0) Moderate 2 (12.5)* 1 (20.0)** Severe 0 0 Serious AEs 1 (12.5)* 0 ▪ No reports of drug - related ocular or systemic SAEs in either arm ▪ One event of acute endophthalmitis in OTX - TKI arm which occurred following mandated aflibercept injection at Month 1 ▪ Reported as moderate ▪ Injection procedure related ▪ Unrelated to the study drug ▪ Resolved after intravitreal antibiotic injection, with vision returning to baseline ▪ All events were mild except ▪ Acute endophthalmitis SAE (moderate and resolved) and worsening of cataract (moderate) in OTX - TKI arm ▪ Elevated IOP in aflibercept arm (moderate and resolved) *Moderate and serious ocular AE in OTX - TKI arm was Acute Endophthalmitis 6 days after mandated aflibercept injection at Month 1 **Moderate AE in Aflibercept arm was Elevated Intraocular pressure Data cut off April 14, 2023 IOP=intraocular pressure; SAE=serious adverse event