Topical treatment of diabetic macular edema using dexamethasone ophthalmic suspension: A randomized, double‐masked, vehicle‐controlled study. Issue 1 (18th July 2022)

• Record Type: Journal Article
• Authors: Stefansson, Einar; Loftsson, Thorstein; Larsen, Michael; Papp, András; Kaarniranta, Kai; Munk, Marion R.; Dugel, Pravin; Tadayoni, Ramin
• Is Part Of: Acta ophthalmologica. Volume 101:Issue 1(2023)
• Page Start: 22
• Page End: 33
• Publication Date: 2022-07-18
• Subjects: clinical trials -- cyclodextrin -- dexamethasone -- diabetic macular edema -- formulation technology -- topical treatment; Ophthalmology -- Periodicals; 617.7005
• DOI: 10.1111/aos.15215
• Languages: English
• ISSNs: 1755-375X

Abstract

Abstract: Purpose: To evaluate topical dexamethasone ophthalmic suspension OCS‐01 (Oculis SA, Lausanne, Switzerland) in diabetic macular edema (DME). Methods: This was a multicenter, double‐masked, parallel‐group, randomized, Phase 2 study. Patients aged 18–85 years with DME of <3 years duration, ETDRS central subfield thickness ≥ 310 μm by SD‐OCT, and ETDRS letter score ≤ 73 and ≥ 24 in the study eye were randomized 2:1 to OCS‐01 or matching vehicle, 1 drop 3 times/day for 12 weeks. Efficacy was evaluated as change from baseline to Week 12 of ETDRS letter score and central macular thickness (CMT). The primary analysis used a linear model with baseline ETDRS letters as a covariate, and missing data imputed using multiple imputation pattern mixture model techniques. Active treatment was considered superior to vehicle if the one‐sided p ‐value was <0.15 and the difference in mean change from baseline in ETDRS letters was >0. Results: Mean CMT showed a greater decrease from baseline with OCS‐01 ( N = 99) than vehicle ( N = 45) at Week 12 (−53.6 vs −16.8 μm, p = 0.0115), with significant differences favouring OCS‐01 from Weeks 2 to 12. OCS‐01 was well‐tolerated, and increased intraocular pressure was the most common adverse event. Mean change in ETDRS letter score from baseline to Week 12 met the p was +2.6 letters with topical OCS‐01 and 1 letter with vehicle ( p = 0.125). In a post‐hoc analysis, there was a greater difference in patients with baseline BCVA ≤65 letters, the OCS‐01 group improved 3.8 letters compared with 0.9 letters with vehicle. Conclusion: Topical OCS‐01 was significantly more effective than vehicle in improving central macular thickness in patients with DME. Visual improvement was better in eyes with lower baseline vision.