Slide 1: Phase 3 Study of OTX-DP for Chronic Allergic Conjunctivitis
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®) Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about future expectations, plans and prospects for the Company, including statements about the development and regulatory status of the Company’s product candidates, such as the Company’s expectations and plans regardin
Slide 3: Allergy 2nd Phase 3 Study Design
Allergy 2nd Phase 3 Study Prospective/Randomized/Double-Masked/Vehicle-Controlled - OTX-DP (DEXTENZA™, sustained release dexamethasone, 0.4mg) Placebo Drug Delivery Vehicle (PV) N=86: Intent to Treat (ITT) population; N=78: Per Protocol (PP) population* Treatment Duration: 30 days, or until OTX-DP o
Slide 4: Methods & Study Schedule
Methods & Study Schedule Visit 1 (Day -5 +1) Visit 2A (Day -4 +1) Visit 2B (Day -4 +1; 8 hours post V2A) Visit 3A (Day -3+1; 24 hours post V2A) Visit 3B (Day 1; Enrollment) Visit 4 (Day 6) Visit 5A (Day 7) Visit 5B (Day 7; 8 hours post V5A) Visit 6 (Day 8; 24 hours post V5A) CAC Confirmation #1 CAC
Slide 5: Treatment Success Criteria
Treatment Success Criteria Based on previous guidance from FDA on the Ora-CAC Ò model To demonstrate efficacy for ocular itching (Primary Endpoint), OTX-DP needs to show statistical significance (p < 0.05) at all three post-CAC time points: 3(±1), 5(±1), 7(±1) minutes at 7 days post-treatment and cl
Slide 6: Primary Efficacy Summary
Primary Efficacy Summary Parameter Time point OTX-DP Vehicle ANCOVA LS Means Treatment Difference (P value) Meets Success Criteria Ocular Itching 3 min 2.08 2.26 -0.18 (0.4400) NO 5 min 2.09 2.39 -0.29 (0.2230) 7 min 2.05 2.33 -0.29 (0.2611) No statistically significant treatment difference (p>0.05)
Slide 7: Itch Score versus Time
Itch Score versus Time Itch Score Days 3 minutes post challenge 5 minutes post challenge 7 minutes post challenge Error bars are SEM * p<0.05 Visit 6 Visit 6 Visit 6 Vehicle control (PV) OTX-DP Insertion Insertion Insertion
Slide 8: Redness Score versus Time
Redness Score versus Time Redness Score Days 7 minutes post challenge 15 minutes post challenge 20 minutes post challenge Error bars are SEM * p<0.05 Visit 6 Visit 6 Visit 6 Vehicle control (PV) OTX-DP insertion insertion Insertion
Slide 9: Ocular Itching Score at Visit 6
Ocular Itching Score at Visit 6* 2nd Phase 3 Study 2nd Phase 3 Study Excluding 5000 Allergen Units (AU) Time (post-Ora-CAC™) OTX-DP PV Difference OTX-DP PV Difference (% excluded) n 39 33 22 22 39.7% 3 min 2.08 2.26 -0.18 1.98 2.61 -0.63 5 min 2.09 2.39 -0.29 1.99 2.74 -0.75 7 min 2.05 2.33 -0.29 1.
Slide 10: Allergy Trial: Itching: Intent to Treat (ITT) Population
2nd Phase 3 Allergy Trial: Itching: Intent to Treat (ITT) Population* Minutes Post-CAC OTX-DP PV 3 5 7 Visit n n Mean Difference t-test p-value Mean Difference t-test p-value Mean Difference t-test p-value 4 22 25 -0.74 0.0166 -0.80 0.0090 -0.86 0.0055 5a 22 24 -0.58 0.0575 -0.70 0.0216 -1.10 0.0010
Slide 11: Itching: ITT Population with LOCF, Area Under the Curve
2nd Phase 3 Allergy Trial: Itching: ITT Population with Last Observation Carried Forward (LOCF)* Area Under the Curve Visit OTX-DP Vehicle Post-CAC Average of 3, 5, 7 minute time-points n n Mean Difference t-test p-value V4 - V6 (5-7 days post insertion) 39 36 -0.96 0.0766 V7 - V9 (12-14 days post i
Slide 12: Itching: ITT with LOCF excluding 5000 AU subjects
2nd Phase 3 Allergy Trial: Itching: ITT Population with LOCF* Area Under the Curve excluding subjects requiring allergen dose of 5000 Allergen Units (AU) Visit OTX-DP Vehicle Post-CAC Average of 3, 5, 7 minute time-points n n Mean Difference t-test p-value V4 - V6 (5-7 days post insertion) 22 25 -1.
Slide 13: Ocular Adverse Event (AE) Summary
Ocular Adverse Event (AE) Summary OTX-DP (N=41) Vehicle (N=42) Total- Ocular AEs 6 9 Number of subjects with at least one ocular AE 5 (12.2%) 6 (14.3%) Eye Pruritus Dacryostenosis Acquired Eye Discharge Eyelid Oedema Lacrimal Structure Disorder Visual Acuity Reduced 0 0 0 1 (2.4%) 0 1 (2.4%) 2 (4.8%
Slide 14: Conclusions
Conclusions OTX-DP did not meet primary endpoint for itching at Visit 6 (7 days post-insertion). While trial design was otherwise identical to first Phase 3 trial a much higher proportion (~40% vs. ~19%) of subjects received maximal allergen challenge dosing (5000 Allergen Units), which may have imp