Objective:
To evaluate the efficacy and safety of OCS-01 eye drops in patients with diabetic macular edema (DME).
Key Findings:
- Patients receiving OCS-01 gained a mean of 7.2 ETDRS letters at week 6 compared to 3.1 letters for vehicle patients (P=.007).
- 25.3% of OCS-01 patients achieved ≥15-letter improvement at week 6 vs 9.8% for vehicle (P=.025).
- Mean central retinal thickness decreased by 71 μm in treatment-naïve eyes and 52.3 μm in previously treated eyes.
Interpretation:
OCS-01 demonstrated rapid and sustained improvements in BCVA and retinal thickness, indicating its potential as a noninvasive treatment for DME.
Limitations:
- The study is in the initial phase, and further validation is needed in stage 2 trials.
- Adverse events were reported, including increased intraocular pressure and macular edema.
Conclusion:
OCS-01 met all functional, clinical, and pharmacodynamic endpoints, supporting its potential as a treatment option for DME.
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