OCS-01 eye drops reduce inflammation, pain after cataract surgery in phase 3 trial
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Key takeaways:
- The phase 3 OPTIMIZE trial met both primary efficacy endpoints.
- OCS-01 eye drops reduced inflammation and pain after cataract surgery.
OCS-01 eye drops demonstrated positive topline results for the treatment of inflammation and pain after cataract surgery, according to a press release from Oculis.
The double-masked, placebo-controlled phase 3 OPTIMIZE trial included 119 participants who received a once-daily drop of high-concentration dexamethasone compared with 122 participants who received vehicle for 14 days after cataract surgery.
Image: Adobe Stock
The trial met both primary efficacy endpoints. At day 15, 57.2% of those who received OCS-01 experienced no inflammation compared with 24% of those who received vehicle, while at day 4, 75.5% of those who received OCS-01 experienced an absence of pain compared with 52% of those who received vehicle (P < .0001 for both).
Ocular treatment-emergent adverse events were more common in those who received vehicle compared with those who received OCS-01 (84 participants vs. 37 participants). Overall, OCS-01 was well tolerated and had a positive safety profile.
The mean change in IOP from baseline to day 15 was –0.9 mm Hg, with no meaningful difference between the two groups.
“We are on track to advance OCS-01 for inflammation and pain following ocular surgery towards an NDA submission with FDA,” Riad Sherif, MD, CEO of Oculis, said in the release. “We now have positive phase 3 topline results with OCS-01 preservative-free eye drops in treating front-of-the-eye inflammation and pain following ocular surgery, as well as stage 1 phase 3 results for back-of-the-eye diabetic macular edema from the DIAMOND program, opening for the first time ever new opportunities for topical eye drops to address highly unmet patient needs in both front- and back-of-the-eye indications.”
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