Oculis S.A. announced the first patient visit in stage 2 of the phase 3 DIAMOND-1 study investigating OCS-01 eye drops for the potential treatment of diabetic macular edema (DME).
Let’s start with OCS-01.
Oculus’s lead investigational candidate, OCS-01 is a novel, high-concentration (15 mg/ml), topical drug candidate of dexamethasone that employs Oculis’ Optireach solubilizing nanoparticle technology.
To note, this technology is a proprietary platform designed to enable the formulation of drugs as non-invasive topical treatments, potentially extending their residence time on the eye surface along with enhancing bioavailability in relevant eye tissues.
Gotcha. Now about this phase 3 study…
The phase 3 DIAbetic Macular edema patients ON a Drop (DIAMOND-1) study (NCT05066997) is a two-stage pivotal, double-masked, randomized, vehicle-controlled, multicenter (39 sites), multi-country (in the United States and Europe) trial measuring OCS-01 in an estimated total of 497 patients with DME over a 3-month period.
The first stage (n = 148) compared OCS-01 to a vehicle while the second stage is evaluating OCS-01 alone.
See here for patient criteria.
And what’s being measured?
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 then to week 52.
The study’s secondary endpoint is measuring the incidence of treatment-emergent adverse events (TEAEs).
So what did stage 1 find?
Oculus reported positive data in May 2023, with OCS-01 meeting both primary and secondary endpoints with statistical significance as well as achieving its primary goal of identifying an optimal dosing regimen for stage 2.
See here for details.
Now talk about stage 2.
Investigators are targeting an estimated enrollment of 350 to 400 participants.
Each patient is being randomized 1:1 to be administered OCS-01 or vehicle six times daily for a 6-week period followed by three times daily for a 46-week maintenance period.
When can we expect new data?
While Clinical Trials is slating the DIAMOND study to conclude by August 2025, topline data will likely be reported some time in 2024.
And the significance?
OCS-01 has the potential to become the first topical eye drop and noninvasive treatment for DME, possibly allowing patients to receive rapid and improved access to treatment.
And according to CEO Riad Sherif, MD, the eye drop “has already demonstrated its potential to treat both front and back of the eye indications” with the DIAMOND study’s stage 1 data as well as the recently-released phase 3 OPTIMIZE trial data on OCS-01 for inflammation and pain following cataract surgery.