Oculis Holding has concluded subject enrolment for the Phase III DIAMOND-1 and DIAMOND-2 clinical trials of OCS-01 eye drops for diabetic macular oedema.
These randomised, double-masked, multi-centre trials are designed to evaluate the efficacy and safety of the eye drops in this patient population.
More than 800 subjects were enrolled at 119 investigative sites across the US and several other nations.
Subjects in these trials were randomised into a 1:1 ratio to receive either OCS-01 or a vehicle six times a day for the six-week induction phase, followed by three times a day until week 52 for the maintenance phase.
According to the company, the change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter scores at week 52 is the trial’s primary endpoint. Secondary endpoints include the percentage of subjects with a ≥15-letter gain in BCVA and the change in central subfield thickness (CST), both at week 52.
Oculis CEO Riad Sherif said: “The completion of enrolment in both the DIAMOND-1 and DIAMOND-2 Phase III trials shows a strong focus on disciplined execution.
“For the months to come, we will remain focused on execution to ensure the programme’s continued advancement, bringing us closer to potentially providing a transformational solution, with the first non-invasive topical eye drop therapy for patients suffering from diabetic macular oedema.”
The commencement of these trials was based on positive findings from Stage I of the DIAMOND programme, which was announced in the second quarter of 2023.
These trials are essential in supporting worldwide marketing applications, including submitting a new drug application (NDA) to the US Food and Drug Administration for approval.
The trials’ top-line data is anticipated in the second quarter of 2026, with the NDA filing expected to follow later in the year.
Earlier this year, the company reported that the Phase II ACUITY trial of OCS-05 for treating acute optic neuritis met the primary endpoint.
