Ocular Therapeutix, Inc. · NASDAQ:OCUL
Ocular Therapeutix — Investor Presentation (January 2021)
33 slides from Ocular Therapeutix's investor presentation, Jan 11, 2021
Slide 1: Transforming Drug Delivery Leveraging a Novel Technology Platform
TRANSFORMING DRUG DELIVERY LEVERAGING A NOVEL TECHNOLOGY PLATFORM (NASDAQ: OCUL) ANTONY MATTESSICH, CHIEF EXECUTIVE OFFICER January 2021
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS 2 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
Slide 3: Transforming Drug Delivery with a Novel Technology Platform
TRANSFORMING DRUG DELIVERY WITH A NOVEL TECHNOLOGY PLATFORM 3
Slide 4: Pipeline at a Glance
PIPELINE AT A GLANCE 7 5 REGULATORY PRODUCT/PROGRAM DISEASE STATE PRECUNICAL PHASET PHASE2 PHASES REPEAL CPATI en Ae » OTX-AFS Wet AMD, » ‘Reotobonation wih REGENERON DME and RYO: omxX-tic ‘Glaucoma and »» OTX-DED Episodic dry (Goxamethosone itkoconotcuorinert)| eye disease eons. cori LZ» Dexten re.
Slide 5: Total Global Markets
TOTAL GLOBAL MARKETS 5 DEVELOPING PRODUCTS WITH THE POTENTIAL TO BECOME A STANDARD OF CARE FOR SELECT INDICATIONS IN SEVERAL OF THE LARGEST SEGMENTS IN OPHTHALMOLOGY KEY UNMET NEED RETINAL DISEASES OTX - TKI axitinib intravitreal implant OTX - AFS * aflibercept suprachoroidal injection DURABILITY $1
Slide 6: OTX-TKI (Axitinib Intravitreal Implant)
OTX - TKI ( AXITINIB INTRAVITREAL IMPLANT) ISSUES WITH EXISTING TREATMENTS • Require injections every 4 - 8 weeks 1,2 • May cause endophthalmitis, hemorrhage, damage to the lens or retinal detachment due to repeated injections 3 • Cause discomfort, eye pain, decreased vision, increased photosensitiv
Slide 7: OTX-TKI Phase 1 Study Design
OTX - TKI PHASE 1 STUDY DESIGN • Open - label, dose - escalation, feasibility study • 5 sites in Australia • One eye treated per patient • Key Inclusion criteria: • Active primary subfoveal neovascularization (SFNV) secondary to AMD – previously treated or naïve subjects but with retinal fluid prese
Slide 8: Individual Change in Central Subfield Thickness OTX-TKI Study Eye – Cohort 2
INDIVIDUAL CHANGE IN CENTRAL SUBFIELD THICKNESS OTX - TKI STUDY EYE – COHORT 2 8 *All BCVA and CSFT values compared to Baseline visit NOTE: Interim review, unmonitored data; Data cut on September 10 th , 2020 (Cohorts 1 & 2 only) Denotes administration of rescue therapy *All CSFT values compared to
Slide 9: OTX-TKI Phase 1 SD-OCT Evaluation
OTX - TKI PHASE 1 SD - OCT EVALUATION 9 COHORT 3A 600 µg - Subject 1 (OS): Treatment Naïve COHORT 2 400 µg - Subject 2 (OD): History of Aflibercept Q4 Weeks for 16 months BASELINE MONTH 2 MONTH 3 MONTH 4.5 CSFT: 513 μ m CSFT: 354 μ m CSFT: 236 μ m BCVA 0.58 (20/76) 0.22 (20/33) 0.24 (20/40) 0.1 (20/
Slide 10: Adverse Events and Rescue Medication
10 Adverse Events Number of subjects with: Cohort 1 200 μ g n=6 Cohort 2 400 μ g n=7 Total n=13 Adverse Events (AEs) 14 17 31 Ocular AEs 12 12 24 Serious Ocular AEs 0 0 0 By severity Mild Moderate Severe 12 2 0 14 3 0 26 5 0 Treatment - related Ocular AEs 1 2 3 * Only 5 of 7 subjects reached 9 month
Slide 11: OTX-TKI Conclusions to Date
OTX - TKI CONCLUSIONS TO DATE Study is ongoing Continued long - term evaluation of both cohorts • Need to establish durability of treatment • Identify Maximum Tolerated Dose (MTD) • Understand utility of OTX - TKI with anti - VEGF injection 11 □ OTX - TKI was generally well tolerated To date, observ
Slide 12: Regeneron Partnership OTX-AFS
REGENERON PARTNERSHIP OTX - AFS (AFLIBERCEPT SUPRACHOROIDAL INJECTION)* 12 AMENDED AGREEMENT TO DEVELOP A NOVEL, SUSTAINED - RELEASE FORMULATION OF EYLEA ® (AFLIBERCEPT) ▪ Evaluating opportunity to incorporate aflibercept with our sustained release hydrogel for injection in the suprachoroidal space
Slide 13: Total Global Markets
TOTAL GLOBAL MARKETS 13 DEVELOPING PRODUCTS WITH THE POTENTIAL TO BECOME A STANDARD OF CARE FOR SELECT INDICATIONS IN SEVERAL OF THE LARGEST SEGMENTS IN OPHTHALMOLOGY SURGICAL post - surgical inflammation & pain HANDS - FREE $1B 4 KEY UNMET NEED DRY EYE DISEASE OCULAR SURFACE DISEASES dexamethasone
Slide 14: OTX-TIC (Travoprost Intracameral Implant)
ADDRESSES THE ISSUE OF PATIENT NON - COMPLIANCE WITH EYE DROPS OTX - TIC ( TRAVOPROST INTRACAMERAL IMPLANT) 14 ISSUES WITH EXISTING TREATMENTS • High rates of non - adherence to glaucoma therapies • Poor adherence has been shown to be associated with disease progression and blindness 1,2 • Ocular hy
Slide 15: OTX-TIC for the Treatment of Glaucoma Phase 1 Study Design
OTX - TIC FOR THE TREATMENT OF GLAUCOMA 15 Phase 1 Study Design • Open - label, proof - of - concept study • US study, 20 subjects at 5 sites • 5 subjects per cohort, 4 cohorts • One eye per patient will be treated • Key Inclusion criteria: ▪ Controlled ocular HTN or POAG ▪ Open, normal anterior cha
Slide 16: IOP Decrease Recorded in Cohorts 1 & 2
IOP DECREASE UP TO 7 - 10 MMHG RECORDED IN COHORTS 1 (UP TO 18 MONTHS) & 2 (UP TO 9 MONTHS) 16 DECREASED IOP AS EARLY AS TWO DAYS AFTER OTX - TIC IMPLANTATION NB: Interim look; Unmonitored data *If the study eye was given other IOP lowering medication, the IOP value was removed from the analysis. Da
Slide 17: OTX-TIC Phase 1 Interim Findings
Clinically - meaningful decrease in IOP Mean IOP values were decreased in patients receiving both OTX - TIC and topical travoprost as early as two days following administration, and mean IOP values remained decreased from baseline values Extended duration of therapy Many subjects exhibited duration
Slide 18: Total Global Markets
TOTAL GLOBAL MARKETS 18 DEVELOPING PRODUCTS WITH THE POTENTIAL TO BECOME A STANDARD OF CARE FOR SELECT INDICATIONS IN SEVERAL OF THE LARGEST SEGMENTS IN OPHTHALMOLOGY GLAUCOMA SURGICAL post - surgical inflammation & pain HANDS - FREE $1B 4 KEY UNMET NEED GLAUCOMA OTX - TIC travoprost intracameral im
Slide 19: Intracanalicular Inserts: An Innovation in Drug Delivery to the Ocular Surface
INTRACANALICULAR INSERTS 19 AN INNOVATION IN DRUG DELIVERY TO THE OCULAR SURFACE
Slide 20: OTX-CSI (Cyclosporine Intracanalicular Insert)
OTX - CSI (CYCLOSPORINE INTRACANALICULAR INSERT) ISSUES WITH EXISTING TREATMENTS • Slow onset of action for therapy • High level of burning, stinging and irritation upon administration • Burden of patient administration KEY PRODUCT ATTRIBUTES • Cyclosporine loaded in hydrogel • Preservative - free •
Slide 21: OTX-CSI Phase 1 Study Objective and Design
PHASE 1 STUDY OBJECTIVE AND DESIGN 21 OBJECTIVE: EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF OTX - CSI FOR THE TREATMENT OF SUBJECTS WITH DRY EYE DISEASE Study to Evaluate the Safety, Tolerability, and Efficacy of OTX - CSI in Subjects With Dry Eye Disease. ClinicalTrials.gov. https://clini
Slide 22: OTX-CSI Phase 1 Trial Results
OTX - CSI PHASE 1 TRIAL RESULTS 22 SUBJECTS REPORTED IMPROVEMENT IN DRYNESS SEVERITY ON A SCALE OF 0 - 100 (VERY MILD TO VERY SEVERE) OVER 16 WEEKS N=5 subjects; Scale of 0 - 100 How severe are symptoms of dryness and/or irritation? Range: “very mild” to “very severe” IMPROVED TOTAL CORNEAL FLUORESC
Slide 23: OTX-CSI Phase 1 Trial Conclusions
OTX - CSI SHOWS PROMISE AS A POTENTIAL SUSTAINED RELEASE THERAPY FOR DRY EYE DISEASE 23 PHASE 1 TRIAL CONCLUSIONS: • All subjects showed improvement as measured by Schirmer’s test and decreased signs and symptoms of dry eye disease x 20% of subjects (1/5) showed ≥10mm increase in Schirmer’s score at
Slide 24: OTX-CSI Phase 2 Study Objective and Design
24 *Subject remains in study until insert is no longer visible and no evidence of biological activity OBJECTIVE: EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF OTX - CSI FOR THE TREATMENT OF SUBJECTS WITH DRY EYE DISEASE Study to Evaluate the Safety, Tolerability, and Efficacy of OTX - CSI in
Slide 25: OTX-DED (Dexamethasone Intracanalicular Insert)
OTX - DED (DEXAMETHASONE INTRACANALICULAR INSERT) 25 ISSUES WITH EXISTING TREATMENTS • Approved therapies for DED are known for slow onset of action and burning/stinging upon application • Topical steroids (which are not FDA - approved for DED) can be abused and contain preservatives causing ocular
Slide 26: DEXTENZA for the Treatment of Allergic Conjunctivitis
DEXTENZA FOR THE TREATMENT OF ALLERGIC CONJUNCTIVITIS 26 AN IN - OFFICE INDICATION FOR DEXTENZA ISSUES WITH EXISTING TREATMENTS • Corticosteroids are effective in treating both signs and symptoms of acute and chronic allergy • Corticosteroids are not often prescribed due to the ability to abuse and/
Slide 27: Results: Primary Efficacy Endpoint Mean Ocular Itching Scores
RESULTS: PRIMARY EFFICACY ENDPOINT MEAN OCULAR ITCHING SCORES ACROSS ALL STUDIES McLaurin E, et al. Evaluating the Safety and Efficacy of DEXTENZA, a Dexamethasone Insert (0.4 mg) for the Treatment of Ocula r I tching. Presented at the American Society of Cataract and Refractive Surgery Annual Meeti
Slide 28: Global Market Values
GLOBAL MARKET VALUES 28 DEVELOPING PRODUCTS WITH THE POTENTIAL TO BECOME A STANDARD OF CARE FOR SELECT INDICATIONS IN SEVERAL OF THE LARGEST SEGMENTS IN OPHTHALMOLOGY GLAUCOMA KEY UNMET NEED GLAUCOMA OTX - TIC travoprost intracameral implant COMPLIANCE $4.8B 2 DRY EYE DISEASE OCULAR SURFACE DISEASES
Slide 29: The Unmet Need in Treatment of Pain and Inflammation Following Surgery
THE UNMET NEED IN TREATMENT OF PAIN AND INFLAMMATION FOLLOWING SURGERY 29 STEROID DROPS ARE THE MOST COMPLEX POST - OP CATARACT TREATMENT REGIMEN Common clinical approach: 4 weeks with taper 1 LESS THAN 5% OF DROPS REACH OCULAR TISSUE EYE DROPS HAVE POOR CORNEAL RESIDENCE TIME 3,4 1. Kessel L et al.
Slide 30: DEXTENZA (Dexamethasone Ophthalmic Insert)
DEXTENZA ® (DEXAMETHASONE OPHTHALMIC INSERT) 30 A HANDS - FREE ALTERNATIVE TO EYE DROPS FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery REIMBURSEMENT AND CODING Product Code : J1096 Procedure Code : 0356T • Medicare Administrative Contractor coverage provi
Slide 31: 2020 Milestones and Near-Term Achievements
2020 MILESTONES AND NEAR - TERM ACHIEVEMENTS 31 OTX - TKI (wet AMD) • Provided Phase 1 clinical update at AAO (Nov 2020) • FDA acceptance of eIND OTX - CSI (dry eye) – Initiated Phase 2 Clinical Trial (Sept 2020) OTX - DED (episodic dye eye) – Submitted Phase 2 enabling IND OTX - TIC (glaucoma) – Co
Slide 32: Anticipated 2021-2022 Milestones
ANTICIPATED 2021 - 2022 MILESTONES 32 OTX - TKI (wet AMD) – Plan to initiate US Phase 1 clinical trial and ex - US Phase 2 clinical trial mid - 2021 OTX - CSI (dry eye) – Expect topline data from Phase 2 trial 1H 2022 OTX - DED (episodic dye eye) – Plan to initiate Phase 2 clinical trial in Q1 2021
Slide 33: Thank You
TRANSFORMING DRUG DELIVERY LEVERAGING A NOVEL TECHNOLOGY PLATFORM THANK YOU (NASDAQ: OCUL)
Ocular Therapeutix — Investor Presentation (January 2021) on 6ix