Phase 2 data for OCS-01, a proprietary topical nanoparticle formulation of dexamethasone from Oculis to treat patients with diabetic macular edema, demonstrated clinical proof of concept as a topical drug and greater efficacy than vehicle in reducing central macular thickness and improving visual acuity.
Pravin U. Dugel, MD, presented positive data for OCS-01 at Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2020 symposium in Miami. Patients were randomly assigned to receive one drop of either OCS-01 or a matching vehicle eye drop three times per day for 12 weeks. Researchers evaluated the change from baseline to week 12 in central macular thickness (CMT) and ETDRS best corrected visual acuity letter scores.
“This multicenter, prospective, randomized, vehicle-controlled study using dexamethasone in the [soluble nanoparticle technology] platform met its endpoints in OCT and vision in patients with DME. This validates further study of this topical drug to treat chronic retinal diseases,” Dugel told Healio/OSN.
Phase 2 data for OCS-01, a proprietary topical nanoparticle formulation of dexamethasone from Oculis to treat patients with diabetic macular edema, demonstrated clinical proof of concept as a topical drug and greater efficacy than vehicle in reducing central macular thickness and improving visual acuity
The study included 144 patients, of which 133 completed the study. Mean CMT had a greater decrease of –53.6 µm from baseline in the OCS-01 group at 12 weeks compared with a –16.8 µm CMT decrease in the vehicle arm (P = .0115). The OCS-01 group experienced a +2.62 letter gain at 12 weeks compared with a +1.04 letter gain in the vehicle group.
“The Oculis OCS-01 phase 2 study presented in the Angiogenesis meeting was positive proof of concept that the SNP platform is able to effectively impact posterior segment diseases with a topical drug,” Dugel said.
Reference:
Dugel PU. The Oculis OCS-01 phase 1/2 study: an effective topical therapeutic for DME. Presented at: Angiogenesis, Exudation, and Degeneration 2020; Feb. 8, 2020; Miami.
Disclosure: Dugel reports he is the chairman of the scientific advisory board for Oculis.