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Results from the phase 2/3 DIAMOND trial show a significant reduction in central macular thickness and significant visual gain in eyes treated with OCS-01 drops versus sham.
New results from the phase 2/3 DIAMOND trial showed OCS-01 eyedrops showed significant reductions in central macular thickness and significant visual gain in patients with diabetic macular edema (DME), compared to sham.
The results, presented at the 127th Annual American Academy of Ophthalmology (AAO) Congress in San Francisco, California, were noted as statistically significant, with early improvements and reductions in central macular thickness after the second week maintained throughout the study timeframe in the first stage of this trial.
“In this stage, we were able to show that there was a significant reduction in central macular thickness with OCS-01, and there was a significant visual gain also in the OCS-01 treated group versus the sham-treated group,” said Hani Salehi-Had, MD, of Retina Associates of Southern California.
Standard of care for DME is currently intravitreal, anti-vascular endothelial growth factor (VEGF) therapy, on a monthly or every-other-month basis. Salehi-Had noted in DME, in particular, that an alternative route of delivery of a medication could be revolutionary. He indicated his hope that the formulation is going to be able to fill that space, besides the current, available medications.
OCS-01 is a novel, high-concentration (15 mg/ml), topical formulation of dexamethasone. It was developed by Oculis to reach the retina via an eye drop, a route of administration for DME that is in contrast with these currently available therapies.
“We're hoping that this eye drop and this formulation is going to be able to do that at least, or have a space,” Salehi-Had told HCPLive. “Besides that type of medication that we currently use.”
Salehi-Had Hani. A 12-Week Phase 2/3 Double-Masked, Randomized, Multicenter Study of OCS-01 Eye Drops in Diabetic Macular Edema. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.