Ocular Therapeutix, Inc. · NASDAQ:OCUL
Ocular Therapeutix — EURETINA Innovation Spotlight 2023
18 slides from Ocular Therapeutix's conference presentation, Oct 4, 2023
Slide 1: Transformative Investigational Tyrosine Kinase Inhibitor Therapy for Retinal Vascular Diseases
Transformative Investigational Tyrosine Kinase Inhibitor Therapy for Retinal Vascular Diseases OCULAR THERAPEUTIX (NASDAQ: OCUL) Antony Mattessich President & Chief Executive Officer EURETINA Innovation Spotlight 4 th October 2023
Slide 2: Forward-looking statements
2 Any statements in this presentation about future expectations, plans, and prospects for the Company, including the commercial iza tion of DEXTENZA® or any of the Company’s products or product candidates; the development and regulatory status of the Company’s product candidates, incl udi ng the tim
Slide 3: Ocular Therapeutix aims to transform ophthalmic care
3 OCULAR THERAPEUTIX AIMS TO TRANSFORM OPHTHALMIC CARE, BRINGING ADVANCED THERAPIES TO PHYSICIANS AND PATIENTS OBSOLETE EYE DROPS Focused on developing physician - administered, preservative - free, and compliance - improved treatments for ophthalmic diseases that improve outcomes and practice econo
Slide 4: Broad ophthalmology portfolio using Elutyx for continuous drug delivery
4 WE ARE ADVANCING A BROAD OPHTHALMOLOGY PORTFOLIO USING ELUTYX FOR CONTINUOUS DRUG DELIVERY
Slide 5: Broad ophthalmology portfolio using Elutyx for continuous drug delivery
WE ARE ADVANCING A BROAD OPHTHALMOLOGY PORTFOLIO USING ELUTYX FOR CONTINUOUS DRUG DELIVERY 5
Slide 6: Designed to deliver continuous control over wet AMD
6 OTX - TKI IS DESIGNED TO DELIVER CONTINUOUS CONTROL OVER WET AMD References: 1. Zhao Y, et al. Oncologist . 2015;20(6):660 - 673. 2. Gross - Goupil M, et al. Clin Med Insights Oncol. 2013;7:269 - 277. 3. Liang C, et al. Mol Ther Oncolytics . 2022;24:577 - 584. 4. Blizzard CD, Driscoll A, El - Haye
Slide 7: 89% reduction in anti-VEGF treatment burden at 12 months
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 wer
Slide 8: Vision and CSFT comparable to standard of care aflibercept Q8W
Data cut off April 14, 2023; Error bars represent standard deviation * OTX - TKI arm received OTX - TKI at baseline and a single aflibercept injection at Week 4; n=14 in OTX - TKI arm at Weeks 8, 28, 40 and 48 due to missed visits † Sample size for OTX - TKI arm (censoring rescued subjects): n=15 at
Slide 9: Wet AMD noninferiority trials using sham injections no longer acceptable to FDA
9 WET AMD NONINFERIORITY TRIALS USING SHAM INJECTIONS SEEM NO LONGER ACCEPTABLE TO THE FDA FDA recommends a comparative arm in which “dosing frequency, criterion for dosing adjustments and criterion for interventions are the same” for investigational arm 1 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time
Slide 10: Wet AMD noninferiority trials using sham injections no longer acceptable to FDA
0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time (Weeks) OTX - TKI Aflibercept Q8W R 1:1 OTX - TKI Aflibercept 2 mg Study visit Sham injection 10 Reference: 1. Neovascular Age - Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry. US Food and Drug Administr ation. Published
Slide 11: Trial would require a third arm with control injection to maintain masking
OTX - TKI Aflibercept (2 mg) Study visit With the addition of a second control arm, OTX - TKI would need to demonstrate non - inferiority over aflibercept Q8W arm and superiority over control injection arm Control injection TRIAL DESIGN CHALLENGES • Aflibercept Q8W arm has a different dosing frequen
Slide 12: Current FDA guidance allows three ways to demonstrate superiority
12 CURRENT FDA GUIDANCE ALLOWS THREE WAYS TO DEMONSTRATE SUPERIORITY ≥15 LETTER DECREASE Statistically significant smaller percentage of patients with ≥15 letter decrease at 9 months or later ≥15 LETTER INCREASE Statistically significant greater percentage of patients with ≥15 letter increase at 9 m
Slide 13: Patient safety, enrollment feasibility and likelihood of success key considerations
13 PATIENT SAFETY, ENROLLMENT FEASIBILITY & OTX - TKI LIKELIHOOD OF SUCCESS WERE KEY CONSIDERATIONS Factors Considered in Endpoint Selection SAFETY OF STUDY PARTICIPANTS • Screen treatment - naïve subjects who have reasonably good VA , and improve their VA to 20/20, with the goal of maintaining it a
Slide 14: SOL: pivotal clinical trial in wet AMD
14 SOL: OTX - TKI PIVOTAL CLINICAL TRIAL IN WET AMD Multi - center, double - masked, randomized, parallel - group Phase 3 trial KEY INCLUSION CRITERIA • Subjects who are treatment naïve in the study eye with a diagnosis of choroidal neovascularization or sub foveal neovascularization at screening •
Slide 15: Upcoming wet AMD program milestones
Prepare to initiate second pivotal wAMD trial* † H2 2024 15 UPCOMING WET AMD PROGRAM MILESTONES DEC 2023 Submit Special Protocol Assessment (SPA) IRB Approval Initiate contracting with study sites SEP 2023 • Agreement on protocol and analysis with FDA • Screen first subject* x x x *Subject to receip
Slide 16: Pressing need for a more durable wet AMD therapy
+ 9.0 - 0.1 - 8.6 -10 -5 0 5 10 15 0 1 2 3 4 5 6 7 8 Change in Vision (ETDRS Letters) VISUAL ACUITY PRESSING NEED FOR A MORE DURABLE WET AMD THERAPY Anti - VEGF injections are effective, however, their dosing frequencies are a challenge in wet AMD leading to vision loss over time 16 n=599 n=388 n=65
Slide 17: Pressing need for a more durable wet AMD therapy
+ 9.0 - 0.1 - 8.6 -10 -5 0 5 10 15 0 1 2 3 4 5 6 7 8 Change in Vision (ETDRS Letters) VISUAL ACUITY PRESSING NEED FOR A MORE DURABLE WET AMD THERAPY 17 Clinical Trial 1 Mean 11.7 injections/year Open - Label Extension 1 Mean 1.5 injection/year Additional Follow - Up 2 Mean 1.6 injections/year n=599
Slide 18: Committed to safeguarding vision and enhancing lives
Committed to safeguarding vision and enhancing lives
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