Ocular Therapeutix, Inc. · NASDAQ:OCUL
Ocular Therapeutix — Glaucoma 360 2021
17 slides from Ocular Therapeutix's conference presentation, Jan 20, 2021
Slide 1: OTX-TIC Intracameral Hydrogel-Based Travoprost Implant: Phase 1 Trial Update
OTX - TIC, AN INTRACAMERAL HYDROGEL - BASED TRAVOPROST IMPLANT TO TREAT PATIENTS WITH GLAUCOMA & OCULAR HYPERTENSION PHASE 1 TRIAL UPDATE MICHAEL GOLDSTEIN, MD, MBA PRESIDENT, OPHTHALMOLOGY & CHIEF MEDICAL OFFICER GLAUCOMA 360 | VIRTUAL | JANUARY , 2021 (NASDAQ: OCUL)
Slide 2: Financial Disclosure
FINANCIAL DISCLOSURE Sponsorship for the clinical trial: Ocular Therapeutix, Inc. The author(s) do have financial interest in this presentation: Dr. Goldstein is an employee of Ocular Therapeutix 2
Slide 3: Forward-Looking Statements
Any statements in this presentation about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company’s product candidates ; the commercial launch of, and effectiveness of reimbursement codes for DEXTENZA, the conduc
Slide 4: Pipeline at a Glance
PIPELINE AT A GLANCE REGULATORY PRODUCT/PROGRAM DISEASE STATE PRECUNICAL PHASE] PHASE2 PHASES REGPetOMN OTX-TKI Wet AMD, OTX-AFS Wet AMD, » esecaisemessa” OME ond RVO OTX-TIC Glaucoma and » CCS, conicurneny | DIV eve decse _ OTX-DED Episodic dry (Goxamatnarene itconatovirinen) eye disease penny, | a
Slide 5: Factors for Designing a Long Duration Intracameral Implant
Factors for Consideration in Designing a Long Duration Intracameral Implant: DRUG DELIVERY TO THE INTRACAMERAL SPACE □ Clinically - meaningful decrease in IOP Well - tolerated with clinically - meaningful efficacy □ Duration of therapy 4 months or more □ Bioresorbable Duration of drug and duration o
Slide 6: Product Attributes OTX-TIC (Travoprost Implant) for Intracameral Injection
Product Attributes OTX - TIC (TRAVOPROST IMPLANT) FOR INTRACAMERAL INJECTION Video Courtesy Dr. Thomas R. Walters • Travoprost loaded microparticles in hydrogel • Preservative - free • Hands - free alternative to traditional eye drops • Administered via a single injection with proprietary injector (
Slide 7: OTX-TIC Phase 1 Study Design
OTX - TIC PHASE 1 STUDY DESIGN • Open - label, proof - of - concept study • US study, approximately 20 subjects at 5 sites • One eye per patient will be treated • Key Inclusion criteria: • Controlled ocular HTN or POAG • Open, normal anterior chamber angles on gonioscopy EVALUATIONS • Safety, tolera
Slide 8: Cohorts 1 & 2: Mean IOP Change from Baseline
COHORTS 1 & 2: MEAN IOP CHANGE FROM BASELINE 8 NB: Interim look as of 01/12/2021. Unmonitored data (8AM measurements). If the study eye was given other IOP lowering medication, the IOP value was removed from the analysis. - 1.5 - 7.4 - 8.8 - 8.7 - 9.1 - 7.0 - 5.6 - 7.6 - 5.8 - 7.5 - 9.6 - 7.1 - 6.6
Slide 9: Cohorts 3 & 4: Mean IOP Change from Baseline
COHORTS 3 & 4: MEAN IOP CHANGE FROM BASELINE 9 NB: Interim look as of 01/12/2021. Unmonitored data (8AM measurements). If the study eye was given other IOP lowering medication, the IOP value was removed from the analysis. - 0.7 - 8.6 - 7.9 - 10.2 - 11.5 - 7.0 - 4.7 - 13.8 - 10.3 - 8.2 - 6.5 - 0.7 -
Slide 10: IOP Decreased After Implantation, Lowering Up to 7-11 mmHg
IOP Decreased after 2 days following OTX - TIC implantation & Lowering up to 7 - 11 mmHg Recorded ALL COHORTS: MEAN IOP CHANGE FROM BASELINE 10 NB: Interim look as of 01/12/2021. Unmonitored data (8AM measurements). If the study eye was given other IOP lowering medication, the IOP value was removed
Slide 11: All Cohorts: Duration of Effect with One Implant
Cohort 2 Showed the Most Consistent Durable Response in all Subjects up to Month 6 & 50% of Subjects up to Month 9 ALL COHORTS: DURATION OF EFFECT WITH ONE IMPLANT 11 NB: Interim look as of 01/12/2021. Unmonitored data (8AM measurements) ‡ Ongoing follow - up Day 42 % (n/N) Day 85 % (n/N)
Slide 12: Implant Visualization: No Noticeable Movement Observed
• Cohorts 1 & 2: Implant biodegraded by 5 - 7 Months • Cohorts 3 & 4: Fast - degrading implants biodegraded by 3 - 5 months in majority of patients in Cohort 3 (except 1 subject) and appears to have a similar timeline in Cohort 4 (follow - up on - going) IMPLANT VISUALIZATION: NO NOTICEABLE MOVEMENT
Slide 13: All Cohorts: Safety Overview
Ocular Adverse Events in the Study Eye ALL COHORTS: SAFETY OVERVIEW NB: In Cohort 1, two same subjects had iritis and peripheral anterior synechiae. NB: Interim look as of 01/12/2021; Unmonitored data. Number of subjects with ocular AEs: Cohort 1 (15µg) N=5 Cohort 2 (26µg) N=4 Cohort 3 (15µg) N=5 Co
Slide 14: No Effect Observed on Corneal Health
Pachymetry & Endothelial Cell Counts Indicate No Clinically - Meaningful Change from Baseline ALL COHORTS: NO EFFECT OBSERVED ON CORNEAL HEALTH Pachymetry (µm) Endothelial Cell Counts (Automated) 1600 2000 2400 2800 3200 Baseline Day 85 Mo 6 Mo 9 Mo 10 Mo 13 Mo 15 Cohort 1 15 μ g 1600 2000 2400 2800
Slide 15: OTX-TIC Shows Promise as a Sustained-Release Therapy: Conclusions
OTX - TIC shows Promise as a Sustained - Release Therapy with a Long Duration of Action CONCLUSIONS □ Clinically - meaningful decrease in IOP Mean IOP values were decreased in patients receiving both OTX - TIC as early as two days following administration, and mean IOP decrease was comparable to top
Slide 16: Thank You
THANK YOU TRANSFORMING DRUG DELIVERY LEVERAGING A NOVEL TECHNOLOGY PLATFORM (NASDAQ: OCUL) 16
Slide 17: OTX-TIC (Travoprost Implant) for Intracameral Injection Summary
OTX - TIC (TRAVOPROST IMPLANT) FOR INTRACAMERAL INJECTION • Open - label, proof - of - concept study in subjects with Primary POAG or OHT in a Phase 1 trial • Non - study eye receives topical travoprost daily • Four cohorts being evaluated (15μg, 26μg, 15μg fast - degrading and 5μg fast - degrading)