Oculis reports positive data from a phase 2 study of OCS-01, a novel eye drop formulation of dexamethasone, in development for the treatment of diabetic macular edema (DME).
OCS-01 was developed using Oculis’ proprietary Soluble NanoParticle technology (SNP), which acts as an ocular drug carrier to enhance bioavailability of drugs in the posterior segment of the eye.
The DX-211 study was a prospective, multi-center, randomized, double-masked, parallel group, vehicle-controlled study. Type 1 or 2 diabetic patients with DME and central macular thickness (CMT) of ≥ 310 µm by SD-OCT and ETDRS best corrected visual acuity (BCVA) letter score ≤ 73 and ≥ 24 in the study eye were randomized to treatment with OCS-01 or matching vehicle eye drops, 1 drop 3 times per day for 12 weeks. Efficacy was evaluated based on the change from baseline to Week 12 of CMT and ETDRS BCVA letter score. Safety was assessed in terms of adverse events and ophthalmology examination.
A total of 144 patients were randomized and 133 patients (92.3%) completed the study. Mean CMT showed a greater decrease from baseline in the OCS-01 group than the vehicle arm at Week 12 ( -53.6 μm vs -16.8 μm, p=0.0115). Mean change in ETDRS BCVA letter score from baseline to Week 12 was higher in the OCS-01 group than the vehicle group (+2.62 letters vs +1.04 letters, p= 0.125). P values met the pre-specified conditions in the protocol for statistical superiority of OCS-01 vs vehicle. Local ocular tolerability was not significantly different between the OCS-01 and vehicle groups with the exception of change in intraocular pressure (IOP). IOP increases were more common with OCS-01 than vehicle during the treatment period which was consistent with known dexamethasone effects.
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In summary, the study met its pre-defined efficacy endpoints and showed that OCS-01 eye drops were more effective than vehicle in reducing central macular thickness and improving visual acuity in patients with DME. No significant/unexpected ocular adverse events were observed.
“We are delighted by the results. The DX-211 study validates the potential of OCS-01 to provide patients and their physicians with a potentially transformative topical approach for sight-threatening retinal diseases, such as DME,” Riad Sherif, M.D., Chief Executive Officer of Oculis, said. “Furthermore, the study confirms the potential of our unique SNP technology to formulate additional topical therapies to treat back-of-the-eye diseases. The successful completion of this clinical trial, along with the support of the retina community, gives us great confidence for the next development steps ahead for OCS-01.”