Oculis posts terminated Phase 3 OCS-01 cataract trial results after administrative error
Oculis reported results from the terminated OPTIMIZE-2 trial of OCS-01 in post-cataract surgery inflammation and pain, citing a third-party administrative error rather than safety or product quality concerns.
Oculis's main update of the week concerns closed-out results from a terminated Phase 3 cataract surgery trial.
- OCS-01 ophthalmic suspension (dexamethasone 1.5%), Phase 3 "OPTIMIZE-2" trial (NCT06128369) in ocular inflammation and pain following cataract surgery, was terminated due to a sponsor decision to close the study following a third-party administrative error preventing analysis of trial results1, with no issue in the quality of the investigational product and no safety risk to any study participant1. The trial had enrolled 117 participants1, and posted results showed absence of anterior chamber cells at Visit 6 (Day 15) in 40 OCS-01 participants versus 15 on vehicle1, and absence of ocular pain at Visit 4 (Day 4) in 51 OCS-01 participants versus 26 on vehicle1, with no serious adverse events reported in either arm1.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.