OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized,...

Area of Science:

• Ophthalmology
• Pharmacology

Background:

• Cataract surgery can lead to post-operative inflammation and pain.
• Effective management of these symptoms is crucial for patient recovery and visual outcomes.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel topical dexamethasone 1.5% formulation (OCS-01) for treating inflammation and pain post-cataract surgery.
• To compare OCS-01 administered once daily (QD) and twice daily (BID) against a vehicle control.

Main Methods:

• A Phase II, double-masked, randomized, vehicle-controlled, multicenter study.
• Adult patients undergoing unilateral cataract surgery received OCS-01 QD (n=51), OCS-01 BID (n=51), or vehicle (n=51) for 15 days.
• Primary endpoints included absence of anterior chamber cells (ACC) at Day 15 and absence of pain at Day 4.

Main Results:

• Significantly greater reduction in ACC was observed with OCS-01 QD (51%) and BID (66.7%) compared to vehicle (19.6%) at Day 15 (P < 0.001).
• Absence of pain at Day 4 was higher for OCS-01 QD (72.5%) and BID (62.7%) versus vehicle (45.1%), with statistical significance for QD (P=0.005).
• OCS-01 was well tolerated, with fewer adverse events reported in OCS-01 groups compared to the vehicle group.

Conclusions:

• Topical OCS-01 (dexamethasone 1.5%) is effective and well-tolerated for managing post-cataract surgery inflammation and pain.
• Both once-daily and twice-daily dosing regimens demonstrate superior efficacy over vehicle.