OCS-01 eye drops meet primary, secondary endpoints in diabetic macular edema phase 3 trial
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Key takeaways:
- OCS-01 showed a statistically significant improvement in mean BCVA ETDRS score from baseline vs. vehicle.
- The topical agent had a better improvement in retinal thickness vs. vehicle.
OCS-01 eye drops met the primary and secondary endpoints for the treatment of diabetic macular edema in stage 1 of the phase 3 DIAMOND trial, according to a press release from Oculis.
In stage 1 of the double-masked, randomized, multicenter trial, 100 participants received OCS-01 (dexamethasone 15 mg/mL) and 48 participants received vehicle six times daily for a 6-week loading phase, followed by three times daily for a 6-week maintenance phase. The objective of this stage was to select the optimal dosing regimen.
OCS-01 met the primary endpoint with a statistically significant improvement in mean best corrected visual acuity ETDRS score from baseline to week 6 of 7.2 letters compared with 3.1 letters in those who received vehicle (P = .007). The effect was sustained to week 12 (7.6 letters vs. 3.7 letters; P = .016).
For the secondary endpoints, a higher percentage of subjects who received OCS-01 achieved a BCVA improvement of 15 letters or greater from baseline (25.3%) compared with those who received vehicle (9.8%) at week 6 (P = .009); this was sustained to week 12 (27.4% vs. 7.5%; P = .009). In addition, there was a statistically significant decrease in central subfield thickness at week 6 from baseline in those who received OCS-01 vs. vehicle (–63.6 µm vs. +5.5 µm; P < .0001); this decrease persisted to week 12 (–61.6 µm vs. –16 µm; P = .004).
OCS-01 was well tolerated and demonstrated no unexpected adverse events.
“A topical agent has never demonstrated a positive result in DME,” Riad Sherif, MD, CEO of Oculis, said in the release. “Now, OCS-01 has been validated in two different studies with consistent and repeated positive results. We remain focused on advancing with high priority the DIAMOND phase 3 trial to stage 2. This important milestone has the potential to bring us one step closer to providing the first treatment in the form of eye drops to patients with DME.”
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