An eye drop improved visual acuity in patients with diabetic macular oedema (DMO), according to early results from a study presented at the American Academy of Ophthalmology meeting in the United States this month.
In the DIAMOND trial, patients with DME were randomly assigned to receive either OCS-01 (Oculis) (100 patients) or vehicle (48 patients).
Patients used the drops six times per day in a six-week induction phase followed by a six-week maintenance phase of drops three times per day. The primary endpoint was mean change in best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to six weeks.
Presenting the results, Dr Hani Salehi-Had, of Retina Associates of Southern California, said BCVA improved by more than seven ETDRS letters as early as six weeks after starting treatment with OCS-01, twice as many as the control group.
The improvement was maintained at 12 weeks. Additionally, central subfoveal thickness declined rapidly and significantly more compared with the control eye drops.
“OCS-01 is aiming to be the first eye drop developed for the treatment of diabetic macular oedema,” Dr Salehi-Had said. “OCS-01 has the potential to address the unmet need of a noninvasive treatment for diabetic macular oedema.”
If you’re offering a patient that’s in their working career an injection every month versus taking eye drops at home, I think most patients are willing to accept that”
During a discussion after the presentation, Dr Salehi-Had conceded the number of daily doses required might impact patient compliance, but “the diabetic patient population is young”, he said.
“If you’re offering a patient that’s in their working career an injection every month versus taking eye drops at home, I think most patients are willing to accept that.”
“Compliance obviously is going to be an issue that we’re not going to know as much about in the clinical trial setting,” he said. “We’ve seen positive results. I’m hoping this will be translated into the real world.”