Eye drop could provide noninvasive approach to DME treatment
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SAN FRANCISCO — An eye drop improved visual acuity in patients with diabetic macular edema, according to a study presented at Retina Subspecialty Day at the American Academy of Ophthalmology meeting.
“OCS-01 is aiming to be the first eye drop developed for the treatment of diabetic macular edema,” Hani Salehi-Had, MD, said.
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Salehi-Had said it is based on Optireach technology to deliver dexamethasone to the eye in a hydrophilic eye drop.
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 6-week induction phase followed by a 6-week maintenance phase in which they used the drops three times per day. The primary endpoint was mean change in best corrected visual acuity ETDRS letter score from baseline to 6 weeks.
The mean change in BCVA was 7.2 letters in the study group at week 6 compared with 3.1 letters in the control group (P = .007). At week 12, the mean change in BCVA was 7.6 and 3.7 letters, respectively (P = .016).
After 2 weeks of use, patients in the study group experienced a significant decrease in central macular thickness that was maintained throughout the study, Salehi-Had said.
The drop was well tolerated with no unexpected adverse events. None of the reported serious adverse events were related to the study drug.
“OCS-01 holds the potential to address an unmet need of a noninvasive treatment for diabetic macular edema,” Salehi-Had said.
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Salehi-Had H, et al. A 12-week phase 2/3 double-masked, randomized multicenter study of OCS-01 eye drops in diabetic macular edema. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
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