Pharmaceutical company Oculis reported positive outcomes from a phase 3 trial for eye drops that treat diabetic macular edema. If approved, these eye drops have the potential to provide a safer, more effective, and less burdensome treatment option for patients.
Oculis, a global pharmaceutical company focused on eye care, has announced positive results from stage 1 of its phase 3 DIAMOND trial for eye drops (called OCS-01) that treat diabetic macular edema (DME).
DME is a serious complication caused by damage to nerves and blood vessels in the macula – the part of the eye responsible for sharp vision. Current treatments available for DME often require invasive procedures, such as ocular implants or injections.
OCS-01, on the other hand, is a topical eye drop that utilizes Oculis' Optireach technology to deliver the medication to the retina, offering a more convenient treatment option.
“Since it is a topical agent, it also has the potential to be a first-line treatment in DME if approved. In short, I believe the impact of OCS-01 in DME could be a true game-changer,” David Boyer, a co-principal investigator for the trial and adjunct clinical professor of ophthalmology at the Keck School of Medicine, said in a press release.
The first stage of the phase 3 trial involved 148 patients who randomly received OCS-01 or a placebo. The results showed a significant improvement in visual acuity in the group treated with OCS-01.
Visual acuity was measured using an Early Treatment Diabetic Retinopathy Study chart. After six weeks, participants using OCS-01 were able to read an average of seven additional letters on the chart compared to roughly three letters for those using a placebo.
The trial demonstrated that OCS-01 was well-tolerated, with no unexpected side effects. These positive results suggest that OCS-01 has the potential to become the first non-invasive, topical treatment for DME if approved.
OCS-01 eye drops will continue to be studied in the second stage of the DIAMOND trial, which will involve two global trials with approximately 350-450 patients each. The company plans to initiate stage 2 in the second half of 2023.
Arshad Khanani, another co-principal investigator and director of clinical research at Sierra Eye Associates, highlighted the meaningful improvements in visual clarity observed in patients treated with OCS-01.
“As a non-invasive treatment that has shown these positive results, OCS-01 has the potential of benefiting a large number of patients with DME if approved,” he said.
By Arvind Sommi
Senior Associate – diatribe Learn