Phase 3 Stage 1 Results of OCS-01 Eye Drops for the Treatment of DME
DIAMOND (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, clinical program to assess the efficacy and safety of OCS-01 eye drops in DME patients. The primary objective of Stage 1 (n=148) was to select the optimal dosing regimen for Stage 2 which includes two 52-week parallel Phase 3 clinical trials, DIAMOND-1 and DIAMOND-2, and study the efficacy and safety of OCS-01.
DIAMOND Phase 3 Stage 1 Results showed robust statistically significant improvement in vision and reduction in retinal edema with OCS-01 vs vehicle:
7.2 letter gain in BCVA versus baseline at week 6, increasing to 7.6 at week 12
25.3% of patients gained ≥15 letters at week 6, increasing to 27.4% at week 12
Rapid reduction in retinal edema already at week 2
Imputation rules are applied based on a pattern-mixture model approach.
BCVA (Best corrected visual acuity); ETDRS (Early Treatment Diabetic Retinopathy Study); ITT (Intention-to-treat).
Tadayoni R, et al. A 12-week phase 2/3 double-masked, randomized, multicenter study of OCS-01 OPTIREACH® technology topical dexamethasone eye drops in subjects with diabetic macular edema (DME): efficacy and safety findings. Presented at: EURETINA; 2023.
* There was no loss of ≥3 lines (>15 ETDRS letters) from baseline to week 6 in either treatment group.
P-value is based on difference in marginal effects. Imputation rules are applied based on a pattern-mixture model approach.
ETDRS (Early Treatment Diabetic Retinopathy Study); ITT (Intention-to-treat).
Tadayoni R, et al. A 12-week phase 2/3 double-masked, randomized, multicenter study of OCS-01 OPTIREACH® technology topical dexamethasone eye drops in subjects with diabetic macular edema (DME): efficacy and safety findings. Presented at: EURETINA; 2023.
Rate of any ocular treatment-emergent adverse event was similar between OCS-01 and vehicle.
Stage 2 of the DIAMOND program was initiated in late 2023 following the positive results of Stage 1 and includes two 52-week parallel Phase 3 trials, DIAMOND-1 and DIAMOND-2.
OCS-01 is an investigational drug and has not received regulatory approval for commercial use in any country.
Mean (±SD) baseline CST: OCS-01, 453.0 (±131.81) µm; vehicle, 445.3 (±112.46) µm. Imputation rules are applied based on a pattern-mixture model approach. CST (Central subfield thickness); ITT (Intention-to-treat); SD-OCT (Spectral domain optical coherence tomography). Oculis. Data on file.
Rate of any ocular treatment-emergent adverse event was similar between OCS-01 and vehicle.
Stage 2 of the DIAMOND program was initiated in late 2023 following the positive results of Stage 1 and includes two 52-week parallel Phase 3 trials, DIAMOND-1 and DIAMOND-2.
OCS-01 is an investigational drug and has not received regulatory approval for commercial use in any country.
The treatment of DME with repeated intravitreal injections results in a significant burden for our patients. As a field, we have been actively seeking for non-invasive alternatives to address DME, aiming to intervene earlier and alleviate treatment burden. OCS-01 eye drops have emerged as a potential solution for this unmet need, and the encouraging results from Stage 1 of the DIAMOND Phase 3 trial support this outlook.”