Sponsor decision to close study due to third-party administrative error preventing analysis of trial results. There was no issue in terms of quality of the investigational product, and no safety risk to any study subject.

The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.

This is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of OCS-01 compared to vehicle in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1 to receive OCS-01 or vehicle once daily.

Inclusion Criteria (Selection):

• Provide written informed consent, approved by the appropriate ethics committee;
• Able to comply with the study requirements and visit schedule;
• At least 18 years of age of either sex or any race;
• Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
• Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours post- uncomplicated cataract surgery without vitreous loss]);

Exclusion Criteria:

• Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
• Have only one functional eye (monocular);
• Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit-lamp examination;
• Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye *Additional inclusion/exclusion criteria apply