Ocular Therapeutix, Inc. · NASDAQ:OCUL
Ocular Therapeutix — Technical Presentation (March 2020)
9 slides from Ocular Therapeutix's technical presentation, Mar 3, 2020
Slide 1: Unmet Need in Retinal Disease: Problem with Immediate-Release Injections
UNMET NEED IN RETINAL DISEASE PROBLEM WITH IMMEDIATE - RELEASE INJECTIONS • While anti - VEGF drugs are effective, they are also rapidly cleared from the vitreous humor; therefore, to reach and to maintain effective concentrations, repeated administrations every 4 - 8 weeks are necessary 1 • Repeate
Slide 2: Drug Delivery to the Intravitreal Space
DRUG DELIVERY TO THE INTRAVITREAL SPACE FACTORS FOR CONSIDERATION IN DESIGNING A LONG DURATION INTRAVITR EAL IMPLANT: □ Clinically - meaningful decrease in retinal fluid Well - tolerated with clinically - meaningful efficacy □ Extended duration of therapy 3 months or more □ Consistently bioresorbabl
Slide 3: OTX-TKI Intravitreal Implant in Phase 1 Trial for AMD
INTRAVITREAL INJECTION IN A PHASE 1 CLINICAL TRIAL FOR THE TREATMENT OF AGE - RELATED MACULAR DEGENERATION DESCRIPTION: • Targeting sustained release for 3 to 6+ months • Broader anti - angiogenic profile than anti - VEGF alone and longer duration (small molecule) • Systemic TKI efficacy established
Slide 4: Phase 1 Study Design
OTX - TKI PHASE 1 STUDY DESIGN • Open - label, dose - escalation, feasibility study • 5 sites in Australia • 9 - month study • One eye per patient will be treated • Key Inclusion criteria: x Active primary SFNV secondary to AMD OBJECTIVES • Safety, tolerability, and biological activity • Safety eval
Slide 5: Mean Change in Central Subfield Thickness by Cohort
MEAN CHANGE IN CENTRAL SUBFIELD THICKNESS VALUES STUDY EYE BY COHORT *Cohort 1 subjects 02 - 001 and 01 - 001 CSFT compared to Baseline visit; remainder of subjects CSFT compared to Screening visit *Cohort 2 subjects CSFT all compared to Baseline visit *All BCVA values compared to Baseline visit -20
Slide 6: Individual Subject Durability Assessment
INDIVIDUAL SUBJECT DURABILITY ASSESSMENT Pre - Treatment Phase OTX - TKI Treatment Phase 1 – Naive 2 – Q4W 3 – Q4W 4 – Q12W 5 – Q2W 6 – Naïve 1 – Q4W 2 – Naïve 3 – PRN 4 – PRN 5 – Naïve 6 – Q4W OTX - TKI 200 µg (Cohort 1) n=6 OTX - TKI 400 µg (Cohort 2) n=6 Months: 1 2 3 4 5 6 7 8 9 10 11 0 - 1 - 2
Slide 7: Cohort 2: SD-OCT Evaluation
COHORT 2: SD - OCT EVALUATION CSFT: 473 μ m CSFT: 513 μ m CSFT: 368 μ m CSFT: 343 μ m CSFT: 337 μ m CSFT: 316 μ m Subject 2: Treatment Naïve S - 01 - 008; OD S - 01 - 008; OD S - 01 - 008; OD S - 01 - 009; OS S - 01 - 009; OS S - 01 - 009; OS Subject 1: History of EYLEA Q4 Weeks BASELINE MONTH 2 MON
Slide 8: Cohort & Safety Overview: Total Adverse Events
COHORT 1 & 2 SAFETY OVERVIEW TOTAL ADVERSE EVENTS Interim look; Unmonitored data. Number of subjects with: OTX - TKI 200 μ g N=6 OTX - TKI 400 μ g N=6 Total (n=12) Adverse Events (AEs) 17 12 29 Treatment - related AEs 2 1 3 Injection procedure - related AEs 1 4 5 By severity Mild Moderate Severe 14
Slide 9: Conclusions: To Be Confirmed
OTX - TKI CONCLUSIONS: TO BE CONFIRMED □ Clinically - meaningful decrease in retinal fluid To date, OTX - TKI was generally well tolerated and observed to have a favorable safety profile in both cohorts. In the higher dose cohort, some subjects showed a decrease in intraretinal or subretinal fluid a
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