
A randomized, phase 2 study evaluated the topical dexamethasone ophthalmic suspension OCS‐01 in diabetic macular edema (DME). Mean central macular thickness showed a greater decrease from baseline with OCS‐01 than vehicle at Week 12, 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. The mean change in ETDRS letter score from baseline to Week 12 was +2.6 letters with topical OCS‐01 and 1 letter with the vehicle. The OCS‐01 group improved by 3.8 letters compared with 0.9 letters with the vehicle. Based on the results, topical OCS‐01 was significantly more effective than vehicle in improving central macular thickness in patients with DME.
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