Slide 1: OCS-01 OPTIMIZE Trial - Phase 3 Topline Results
OCS-01 | OPTIMIZE Trial - Phase 3 Topline Results Treatment of pain and inflammation in post cataract surgery August 8, 2023 Rethinking Ophthalmology Exhibit 99.2
Slide 2: Forward-looking statements
These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expre
Slide 3: Welcome to OPTIMIZE Trial Phase 3 Topline Results
Welcome to OPTIMIZE Trial Phase 3 Topline Results Opening Remarks Sylvia Cheung Chief Financial Officer OCS-01 Phase 3 OPTIMIZE Riad Sherif, M.D. Chief Executive Officer Q&A Session Eric Donnenfeld, M.D., Oculis SAB Michael Korenfeld , M.D., Principal Investigator, OPTIMIZE trial Riad Sherif, M.D.,
Slide 4: Key Opinion Leaders
Key Opinion Leaders ERIC DONNENFELD, M.D. Dr. Donnenfeld is a trustee of Dartmouth Medical School and a clinical professor of ophthalmology at New York University. He is past president of American Society of Cataract and Refractive Surgery, president-elect of the International Intraocular Implant So
Slide 5: OCS-01 in Phase 3 OPTIMIZE Trial Meets Both Primary Endpoints
OCS-01 in Phase 3 OPTIMIZE Trial Meets Both Primary Endpoints Highly significant reduction in pain and inflammation following cataract surgery in a consistent way with SKYGGN Trial (OCS-01 Ph2) Next Step: Second Phase 3 Trial Commence a second Phase 3 trial to support NDA submission of OCS-01 for th
Slide 6: Ocular Surgery is the Most Common Surgical Intervention in the World
Ocular Surgery is the Most Common Surgical Intervention in the World1 Post-operative treatment regimen is required to mainly control pain and inflammation Cataract extractions are the most prevalent surgical procedure of all medical specialties1: aAnterior ocular procedures include cataract, MIGS, L
Slide 7: Current Treatments for Post Ocular Surgery
Current Treatments for Post Ocular Surgery Complex regimens with potential complications, especially cystoid macular edema Current treatments include a combination of topical steroid, antibiotic and NSAID Up to 12 drops a day1 2-6 weeks treatment regimens CME: cystoid macular edema; IOP: intraocular
Slide 8: Unique product candidate with clinically validated MOA
With the potential to address multiple indications Unique product candidate with clinically validated MOA OCS-01: High-concentration Optireach® formulation of dexamethasone (15mg/ml) OPTIREACH® Formulation Technology Longer residence time enables once daily administration in post ocular surgery1 BCV
Slide 9: OPTIMIZE Phase 3 Trial Results
OPTIMIZE Phase 3 Trial Results
Slide 10: OPTIMIZE Trial Evaluated OCS-01 for Treatment of Inflammation and Pain Following Cataract Surgery
OPTIMIZE Trial Evaluated OCS-01 for Treatment of Inflammation and Pain Following Cataract Surgery A multi-center, randomized, double-masked, vehicle-controlled, phase 3 trial of OCS-01 (OPTIREACH®-dexamethasone 15 mg/mL ophthalmic formulation) ACC: anterior chamber cells; AE:adverse event; ETDRS: Ea
Slide 11: OPTIMIZE Patient Disposition
OPTIMIZE Patient Disposition AE: adverse event. Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing. OCS-01 n = 119 Vehicle n = 122 Completed 15 weeks n = 116 Completed 15 weeks n = 118 Discontinued study Withdrawn: n = 1 AE: n = 1 Other: n = 2 Disconti
Slide 12: Baseline Demographics
Baseline Demographics Full analysis set Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing. Parameter OCS-01 (n = 119) Vehicle (n = 122) Mean age, years (SD) 68.8 (7.8) 67.8 (9.0) Age < 65 years, n (%) 24 (20.2) 30 (24.6) Age ≥ 65 years, n (%) 95 ( 79.
Slide 13: Efficacy
Efficacy
Slide 14: Primary Endpoint: Absence of Anterior Chamber Cells on Day 15
Primary Endpoint: Absence of Anterior Chamber Cells on Day 15 Primary analysis, full analysis set P < 0.0001 ACC: anterior chamber cells. Data for visits after receipt of rescue medication, or missing data resulting from withdrawal due to adverse event or lack of efficacy, are singly imputed as fail
Slide 15: Proportion of Patients With Absence of Anterior Chamber Cells by Visit
Primary endpoint Secondary endpoints Proportion of Patients With Absence of Anterior Chamber Cells by Visit Full analysis set ACC: anterior chamber cells. Secondary endpoints contain observed data only. Missing data for the primary endpoint are imputed. Data, analysis, and conclusions are preliminar
Slide 16: Primary Endpoint: Absence of Ocular Pain on Day 4
Primary Endpoint: Absence of Ocular Pain on Day 4 Primary analysis, full analysis set P < 0.0001 Data for visits after receipt of rescue medication, or missing data resulting from withdrawal due to adverse event or lack of efficacy, are singly imputed as failure. Missing data without withdrawal or r
Slide 17: Proportion of Patients With Absence of Ocular Pain by Visit
Primary endpoint Secondary endpoint Secondary endpoints Proportion of Patients With Absence of Ocular Pain by Visit Full analysis set Secondary endpoints contain observed data only. Missing data for the primary endpoint are imputed. Data, analysis, and conclusions are preliminary, and subject to cha
Slide 18: Safety
Safety
Slide 19: Overall Summary of Treatment-Emergent Adverse Events
Overall Summary of Treatment-Emergent Adverse Events Safety population COVID-19: coronavirus disease 2019; TEAE: treatment-emergent adverse event; TE-SAE: treatment-emergent serious adverse event. Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing. OCS
Slide 20: Ocular Treatment-Emergent Adverse Events in the Study Eye
Ocular Treatment-Emergent Adverse Events in the Study Eye (> 2.0% in the OCS-01 Arm or in the Vehicle Arm) Safety population TEAE: treatment-emergent adverse event. Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing. OCS-01 (n = 119) Vehicle (n = 122)
Slide 21: Mean IOP in Study Eyes by Visit
Pre-treatment/ surgery Mean IOP in Study Eyes by Visit Safety population BL: baseline; IOP: intraocular pressure. Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing.
Slide 22: Endothelial Cell Density in Study Eyes by Visit
Pre-treatment/ surgery Endothelial Cell Density in Study Eyes by Visit Safety population BL: baseline. Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing.
Slide 23: Summary
Summary
Slide 24: OCS-01 Efficacy and Safety Summary
OCS-01 Efficacy and Safety Summary Data, analysis, and conclusions are preliminary, and subject to change as full analysis is ongoing. OCS-01 has met the primary endpoints in OPTIMIZE Phase 3 trial, showing superiority over placebo for treatment of inflammation and pain following cataract surgery No
Slide 25: Consistent Results With OCS-01 in OPTIMIZE & SKYGGN Trials
Source Dosing ZERO INFLAMMATION (Day 15) % Drug vs vehicle PAIN FREE (Day 4) % Drug vs vehicle OCS-01 Active Arm P value Active Arm P value OCS-01 SKYGGN Phase 2 Trial 1x/day 51.0% vs 19.6% P = 0.0009 72.5% vs 45.1% P = 0.0049 OCS-01 OPTIMIZE Phase 3 Trial 1x/day 57.2% vs 24.0% P < 0.0001 75.5% vs 5
Slide 26: OCS-01 Results Compared to Current Standard of Care
Phase 3 trial results & Prescribing Information1-4,a Loteprednol 1% 2x/day 50% vs 27% +23% Day 4: 43% vs 25% +18% Difluprednate 0.05% 4x/day 41% vs 12% +29% Day 8: 58% vs 27% +21% Loteprednol 0.38% 3x/day 47% vs 25% +22% Day 8: 74% vs 49% +25% OCS-01 Ph 3 and Ph 2 Results Compared to Current Standar
Slide 27: OCS-01 Could Offer Potential Value to All Stakeholders
Benefits highlighted in independent third-party market research studies with payers & physicians1,2 Ophthalmologists Ocular Surgery Patients Payors Once daily has potential to improve compliance and therefore patient outcomes Positive results in reduction of both pain and inflammation in a once dail
Slide 28: OCS-01 Total Addressable Market Potential
OCS-01 Total Addressable Market Potential $3.9B Current DME Market1 +$5.2B Potential DME Market1 Diagnosed & Untreated $922M US Ocular Steroids4 +$762M Potential CME Market5 +$753M Uveitis3 +$2.3B RVO2 ~$10B+ Potential Market Opportunity Addressable Market Size USD Bn ~$4.7B Diabetic Macular Edema (
Slide 29: Innovative, Diversified and Late-stage Pipeline
AMD; age-related macular degeneration; DR: diabetic retinopathy ; RVO: retinal vein occlusion. OCS-01 is based on the OPTIREACH® technology, OCS-02 is a single chain antibody fragment (ScFv) against TNFα and OCS-05 is a SGK-2 activator peptidomimetic small molecule with novel MoA targeting the activ
Slide 30: Uniquely Positioned to Build Significant Value
Uniquely Positioned to Build Significant Value Targeting critical unmet needs in major ophthalmology segments Near-term value inflection points expected AON: acute optic neuritis ;CME: cystoid macular edema. OCS-01: 1st Eye drop for Diabetic Macular Edema (DME) in Ph3 OCS-01: 1st Once a day Eye drop
Slide 31: Our Purpose
To drive innovation to save sight and improve eye care Our Purpose
Slide 32: Q&A Session
Q&A Session
Slide 33: Q&A Panel
Q&A Panel Riad Sherif, M.D. Sylvia Cheung Eric Donnenfeld, M.D. Michael Korenfeld, M.D. CEO, Oculis CFO, Oculis Oculis Scientific Advisory Board Principal Investigator