Swiss pharmaceutical company Oculis has reported that the first stage of a Phase III trial of OCS-01 eye drops has met both the primary and secondary endpoints.
The DIAbetic Macular oedema patients ON a Drop (DIAMOND) trial has been conducted to assess the safety and efficacy of OCS-01 eye drops in diabetic macular oedema (DME) patients.
A total of 148 patients in 39 sites across the US and Europe have been enrolled in the study.
Of these patients, 48 received a placebo and 100 were treated with OCS-01 six times a day in a loading phase of six weeks, then three times daily for a subsequent maintenance phase of six weeks.
Stage I of the trial met the primary efficacy endpoint of mean change in best corrected visual acuity (BCVA) versus baseline at week six, showing an increase in visual acuity in the treatment arm.
The study also demonstrated statistically significant secondary endpoints showing a higher percentage of patients achieving ≥15-letter improvement in BCVA at week six.
In addition, ≥15-letter improvement was sustained until week 12 with better improvement in retinal thickness and a decrease in central subfield thickness at week six in OCS-01 treated group.
OCS-01 was also well-tolerated and no unexpected adverse events were observed during the study.
Oculis CEO Riad Sherif said: “A topical agent has never demonstrated a positive result in DME. Now, OCS-01 has been validated in two different studies with consistent and repeated positive results.
“This important milestone has the potential to bring us one step closer to providing the first treatment in the form of eye drops to patients with DME which is a devastating and blinding disease.”
Oculis intends to submit OCS-01 for regulatory approval once it completes the 12-month treatment duration.
If approved, OCS-01 will become the first topical and non-invasive treatment for DME.