Ocular Therapeutix, Inc. · NASDAQ:OCUL
Ocular Therapeutix — ASCRS Annual Meeting 2022
11 slides from Ocular Therapeutix's conference presentation, April 2022
Slide 1: Effects of Punctal Occlusion on Ocular Itching and Conjunctival Redness in Allergic Conjunctivitis
Effects of Punctal Occlusion on Ocular Itching and Conjunctival Redness in Subjects with Allergic Conjunctivitis Steven M. Silverstein, MD1; Michelle A. Sato, MD2; Edward J. Meier, MD3; Stella Dai, MSc4; Srilatha Vantipalli, PhD4; Michael H. Goldstein, MD4 1Silverstein Eye Centers, Kansas City, MO;
Slide 2: Disclosures
Disclosures • Presenter: Steven Silverstein was an investigator in the current study. • Co-authors: Michelle A Sato and Edward J. Meier were investigators in the current study. Srilatha Vantipalli and Michael H. Goldstein are employees of Ocular Therapeutix. Stella Dai was a former employee of Ocula
Slide 3: Background
Background Seasonal and perennial allergic Inflammatory Mechanism of Allergic Conjunctivitis conjunctivitis (AC) represent the most common form of ocular allergy1,2 Exposure to an allergen causes release of histamine and results in ocular itching and hyperemia3-5 There is limited evidence on t
Slide 4: Study Design
Study Design Objective: To investigate the effect of punctal occlusion on ocular itching and conjunctival redness associated with allergic conjunctivitis Study Design Phase 3 Study 1 (PIII1), n=35 Three randomized, double- DEXTENZA Phase 3 Study 2 (PIII2), n=44 masked, vehicle-controlled, (N=127)
Slide 5: Placebo-Vehicle Intracanalicular Insert
Placebo-Vehicle Intracanalicular Insert Polyethylene glycol (PEG) hydrogel Insert in the Canaliculus No active ingredient Hydrates and swells to fit the canaliculus Occludes the punctum Degrades and clears the nasolacrimal tract after 30 days Insert Swelling After Hydration Dry Insert Hydr
Slide 6: Standard vs. Modified CAC Model
Standard vs. Modified CAC Model Standard CAC Model1 Early Phase Response Late Phase Response A Single Allergen Challenge Following Day 1 Minute 0 3, 5 and 7 min. Test Article Drug Product Allergen Ocular Itching Administration Administration Challenge Assessments Single Allergen Challenge Early Phas
Slide 7: Ocular Itching Over Time
Ocular Itching Over Time Ocular itch scores decreased over a 1-month period following punctal occlusion POOLED OCULAR ITCHING SCORES FOLLOWING PUNCTAL OCCLUSION (N=128) Punctal Occlusion Period Mean Ocular Itch Scores ±95% CI 4.0 Baseline Week 1 Challenges Week 2 Challenges Week 4 Challenges 3.5 3.0
Slide 8: Ocular Itching Change from Baseline
Ocular Itching Change from Baseline On Days 7, 14 and 28, ocular itching scores were statistically significantly reduced from baseline (P<0.05) CHANGE FROM BASELINE IN POST-CAC OCULAR ITCHING SCORES (N=128) Day 7 Day 14 Day 28-31 0.0 Change from Baseline in Mean Ocular -0.2 -0.4 -0.6 Itching Scores
Slide 9: Conjunctival Redness Over Time
Conjunctival Redness Over Time Following punctal occlusion, post-CAC conjunctival redness scores decreased from baseline for 1 month POOLED CONJUNCTIVAL REDNESS SCORES FOLLOWING PUNCTAL OCCLUSION (N=128) Punctal Occlusion Period 4.0 Mean Conjunctival Redness Scores Baseline Week 1 Challenges Week 2
Slide 10: Conjunctival Redness Change from Baseline
Conjunctival Redness Change from Baseline On Days 7, 14 and 28, conjunctival redness scores were statistically significantly reduced from baseline (P<0.05) CHANGE FROM BASELINE IN POST-CAC CONJUNCTIVAL REDNESS SCORES (N=128) Day 7 Day 14 Day 28-31 0.0 -0.2 Change from Baseline in Mean Conjunctival R
Slide 11: Conclusions
Conclusions Post-hoc, pooled analysis of placebo-vehicle subject data (N=128) from three randomized, masked clinical trials using a modified, repeat CAC model Following punctal occlusion with a hydrogel insert, ocular itching and conjunctival redness decreased from baseline at week 1 and remaine