Ocular Therapeutix, Inc. · NASDAQ:OCUL
Ocular Therapeutix — ASCRS Annual Meeting 2022
10 slides from Ocular Therapeutix's conference presentation, Apr 23, 2022
Slide 1: Real-World Safety Analysis of an Intracanalicular Dexamethasone Insert Using the IRIS Registry
Real-World Safety Analysis of an Intracanalicular Dexamethasone Insert Using the IRIS® Registry (Intelligent Research in Sight) Robert T Chang MD1; Srilatha Vantipalli, PhD2; Dina Akasheh, PhD2; Matthew Cheung, PharmD2; Rabia Gurses-Ozden, MD2; Sonya Li3; Meghan Hatfield3; Andrew LaPrise3; Michael M
Slide 2: Disclosures
Disclosures • Presenter: Robert Chang is a consultant for Verana Health. • Co-authors: Srilatha Vantipalli, Dina Akasheh, Matthew Cheung, and Michael H. Goldstein are employees of Ocular Therapeutix. Meghan Hatfield, Andrew LaPrise, Michael Mbagwu, and Sonya Li are employees of Verana Health. • Fund
Slide 3: Background
Background Dexamethasone • Topical steroids and NSAIDs are often used to (Active Ingredient) prevent and treat postoperative inflammation and pain following ophthalmic surgery1 PEG Hydrogel • Intracanalicular Dexamethasone Insert (Inactive Delivery Platform) (DEXTENZA)2: Alternative to Topical Stero
Slide 4: Study Design: Retrospective Analysis using the AAO IRIS Registry
Study Design: Retrospective Analysis using the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) Objective: To describe real-world safety outcomes of patients who underwent cataract surgery and did or did not receive intracanalicular dexamethasone insert (DEX) Key Incl
Slide 5: Study Population
Study Population Eyes that underwent cataract surgery during index period N = 3,703,177 eyes Cataract procedures at practices with mention of intracanalicular dexamethasone (DEX) N = 647,915 eyes Eyes that received Eyes that did not intracanalicular receive intracanalicular dexamethasone dexamethaso
Slide 6: Incidence of Post-Operative Events
Incidence of Post-Operative Events The overall incidence of inflammation events post-op was low and comparable between the DEX+ and DEX- cohorts POSTOPERATIVE SAFETY EVENTS WITHIN 3 MONTHS 5% Percentage of Patient Eyes 4% 3% 2% 1.42% 1.16% 1.26% 1% 0.63% 0.71% 0.50% 0.58% 0.48% 0.21% 0.10% 0.01% 0.0
Slide 7: Post-Operative Safety Events in Real World vs Clinical Trials
Post-Operative Safety Events in Real World vs Clinical Trials Anterior uveitis and corneal edema were documented less frequently in the real world than observed in clinical trials COMPARISON OF POSTOPERATIVE SAFETY EVENTS IN DEX CLINICAL TRIALS AND THE IRIS REGISTRY 12% DEX Real-World Data (within 3
Slide 8: Intraocular Pressure: No Prior History of Glaucoma
Intraocular Pressure: No Prior History of Glaucoma In patients without glaucoma, rates of IOP elevation ≥10 mmHg were comparable between the DEX+ & DEX- cohort and more frequent on post-op day 1 PERCENTAGE OF EYES WITH IOP CHANGE FROM BASELINE IOP IN ≥10 MMHG FROM BASELINE AT FOLLOW-UP PATIENTS WITH
Slide 9: IOP: Real-World vs Clinical Trial Data in Patients without Glaucoma
IOP: Real-World vs Clinical Trial Data in Patients without Glaucoma PERCENTAGE OF EYES WITH IOP CHANGE FROM BASELINE IOP IN ≥10 MMHG FROM BASELINE AT FOLLOW-UP PATIENTS WITHOUT HISTORY OF GLAUCOMA 10% 10 Eyes with IOP ≥10 mmHg from baseline 8 8% 7.5% from baseline (SD), mmHg 6 Mean change in IOP 6.2
Slide 10: Real World DEXTENZA Safety Conclusions
Real World DEXTENZA Safety Conclusions Current study is the largest analysis performed on patients treated with intracanalicular dexamethasone insert (N=10,313 eyes) Incidences of inflammatory events, corneal edema, CME, endophthalmitis, epiphora, lacrimal disorders dacryocanaliculitis and dacry