Oculis Announces Positive Results from Phase 3 Trial of Once Daily Treatment for Inflammation and Pain Following Cataract Surgery
Oculis announced positive results from the phase 3 OPTIMIZE-1 trial of OCS-01 for the treatment of inflammation and pain following cataract surgery at the 2024 ASCRS annual meeting in Boston.
Eric Donnenfeld, MD, presented the “Once Daily OCS-01, an OPTIREACH Formulation of High Concentration Dexamethasone Eye Drop, for Inflammation and Pain Following Cataract Surgery – a Phase 3, Double-Masked, Vehicle-Controlled Study” on April 7. The results showed that 57.2% of patients treated with OCS-01 were inflammation free (i.e. absence of anterior chamber cells) at Day 15 (vs. 24.0% with vehicle, P<0.0001), and 75.5% had absence of ocular pain at Day 4 (vs. 52.0% with vehicle, P<0.0001).
“The results from OPTIMIZE-1 were highly compelling, showing statistically significant impact on treating inflammation and pain following cataract surgery. Current treatment regimens require multiple daily doses of different eye drops, and having an effective once daily highly potent and safe anti-inflammatory eye drop with a good tolerability profile would meaningfully reduce the burden for patients, caregivers, and ultimately, improve surgery outcomes," said Dr. Donnenfeld, Clinical Professor of Ophthalmology at New York University and Co-chair of the Oculis Scientific Advisory Board. "OCS-01 is truly a unique product candidate with two specific advantages over conventional eye drops: a highly concentrated formulation with 15 times the concentration of available and approved dexamethasone eye drops and an improved solubility profile to enhance eye tissue penetration. These specific characteristics could explain the impressive results in DME in which OCS-01 eye drops significantly improved visual acuity and reduced macular edema.”
“We are excited that Dr. Donnenfeld shared the results from the OPTIMIZE-1 phase 3 trial of OCS-01 at the ASCRS conference. The development program of OCS-01, a novel eye drop in development for both front-and-back-of-the-eye diseases, is progressing as planned with three ongoing phase 3 trials: the second phase 3 OPTIMIZE-2 trial, and the two ongoing 52-week DIAMOND-1 and DIAMOND-2 phase 3 trials in DME. We look forward to sharing further milestone achievements of our pipeline including the upcoming topline clinical readouts with our differentiated assets as the year progresses," said Riad Sherif, MD, Chief Executive Officer of Oculis.
Oculis initiated the second phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop in late 2023 and topline readout is expected before the end of 2024. The two phase 3 OPTIMIZE trials are expected to support an NDA submission.