Oculis S.A. announced that enrollment is complete for the first stage of the phase 3 Diabetic Macular edema patients On a Drop (DIAMOND) study assessing the efficacy and safety of using OCS-01 for the treatment of diabetic macular edema (DME).
What is OCS-01?
OCS-01 is a novel, high-concentration, topical drug candidate of dexamethasone that employs Oculis’ Optireach solubilizing nanoparticle technology—a proprietary platform that can enable the formulation of drugs as non-invasive topical treatments, potentially extend their residence time on the eye surface along with enhance bioavailability in relevant eye tissues. (via)
What’s its significance?
OCS-01 has the potential to become the first topical eye drop and noninvasive treatment for DME, which could potentially allow for patients to have the opportunity to receive quicker and easier access to treatment.
This may facilitate treating DME earlier in the disease process and/or the possibility of combining with current therapies considered standard of care conceivably improving treatment outcomes.
Tell me more about this study.
The phase 3 trial (NCT05066997) is a two-stage pivotal, double-masked, randomized, vehicle-controlled , multicenter, multi-country study measuring the efficacy and safety of OCS-01 in patients with DME. The first stage will compare OCS-01 to a vehicle while the second stage will look at OCS-01 alone.
What are the key endpoints?
The primary endpoint for both stages of the trial is the mean change in the best-corrected visual acuity Early Treatment Diabetic Retinopathy Study chart (BCVA ETDRS) from baseline to week 6 and to week 52.
The study’s secondary endpoint is measuring the incidence of treatment-emergent adverse events.
Who is eligible for the study?
Qualified subjects were assessed by an independent reading center and required to have DME with the presence of intraretinal and/or subretinal fluid in the study eye. Participants underwent spectral-domain optical coherence tomography (SD-OCT) screening for a central subfield thickness (CST) of ≥310µm (which could be adjusted based on gender-specific requirements).
Additionally, they were required to have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c of ≤12.0% (≤108 mmol/mol) at Visit 1. (via)
When can we expect results?
Oculis expects the treatment phase to be completed and preparation for the stage 1 (Week 6) data readout to be released in mid-2023.