OCS-01 EYE DROPS AND THE OPTIREACH® TECHNOLOGY


Associated tags: Dexamethasone, Solubility, HCUP, Inflammation, FDA, Pain, Patient, Food, Minimisation, OCS, Pharmaceutical industry

Oculis Announces First Patient First Visit in Phase 3 OPTIMIZE-2 Trial of OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery

Retrieved on: 
Wednesday, December 20, 2023
Inflammation, FDA, Pain, Patient, Food, Minimisation, OCS, Pharmaceutical industry

Data from the Phase 3 OPTIMIZE-2 trial is intended to support the Company’s NDA submission to the Food and Drug Administration (FDA).

Key Points: 
  • Data from the Phase 3 OPTIMIZE-2 trial is intended to support the Company’s NDA submission to the Food and Drug Administration (FDA).
  • If approved, OCS-01 has the potential to be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.
  • The OPTIMIZE-2 (Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) is a multi-center, randomized, double-masked, vehicle-controlled Phase 3 trial evaluating OCS-01 for the treatment of inflammation and pain following cataract surgery.
  • Similar to the OPTIMIZE-1 trial, patients in the second Phase 3 OPTIMIZE-2 trial will be treated with once-daily OCS-01 post-cataract surgery versus vehicle for 2 weeks.