A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS 01 Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
Latest Information Update: 29 Aug 2024
At a glance
- Drugs Dexamethasone (Primary)
- Indications Postoperative inflammation; Postoperative pain
- Focus Therapeutic Use
- Acronyms SKYGGN
- Sponsors Oculis Pharma
Most Recent Events
- 27 Aug 2024 According to Oculis Pharma media release, Pre-NDA meeting with U.S. Food and Drug Administration (FDA) completed in August for once daily OCS-01 for the treatment of post-operative inflammation and pain following ocular surgery; Providing a clear path forward for NDA submission in Q1 2025.
- 01 Feb 2023 Results published in the Acta Ophthalmologica
- 08 Dec 2022 Results assessing efficacy and safety by comparing topical dexamethasone 1.5% in a novel formulation (OCS-01) once daily and BID versus vehicle for the treatment of inflammation and pain after cataract surgery, published in the Clinical Therapeutics.