Oculis Announces Positive Topline Results from Phase 3 OPTIMIZE Trial of Once-Daily OCS-01 for Post-Cataract Surgery Inflammation and Pain

Zug, Switzerland and Boston, USAAugust 8, 2023PR Newswire -- Oculis (Nasdaq: OCS), an international biopharmaceutical company dedicated to saving sight and protecting eyes, today announced positive topline results from the Phase 3 OPTIMIZE trial, which evaluated OCS-01 eye drops, an innovative formulation of preservative-free, high-concentration dexamethasone eye drops administered once daily for the treatment of inflammation and pain following ocular surgery.

ActiveThe phase 3 results showed once-daily dosing after ocular surgery.AdministrationThePossibility

OPTIMIZE（Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZEdrops) is a double-blind, placebo-controlled Phase 3 clinical study. A total of 241 patients at 25 clinical trial centers in the United States were randomly assigned in a 1:1 ratio to the OCS-01 group (n=119) and the placebo group (n=122) within 14 days after cataract surgery, receiving once-daily (QD) dosing.

The trial met both stratified primary efficacy endpoints, namely no inflammation on Day 15 and no pain on Day 4, with statistically significant results:

In addition, OCS-01 was well tolerated and demonstrated a good safety profile. Overall, the number of ocular treatment-emergent adverse events (TEAEs) reported was higher in the placebo group (n=84) compared to the OCS-01 QD group (n=37). There was no significant difference in intraocular pressure (IOP) between the OCS-01 group and the placebo group, with the mean change from baseline to Day 15 being -0.90 mmHg.

The superior results in reducing inflammation and pain, as well as safety outcomes, are consistent with those observed in the Phase 2 study, the SKYGGN trial. In the SKYGGN trial, statistically significant results were also achieved for both stratified primary efficacy endpoints, with similar numerical values.

Once approved, OCS-01 is expected to become the new standard of care as the first once-daily, preservative-free corticosteroid eye drop for the treatment of inflammation and pain following ocular surgery.

Following the positive topline results with statistical significance from the first phase of the DIAMOND trial, a Phase 3 clinical study for diabetic macular edema (DME) reported earlier this year, the results of the OPTIMIZE trial further highlight the product’s potential in treating anterior and posterior segment eye diseases. Prior to this announcement, the LEOPARD study — an investigator-initiated trial evaluating the potential of OCS-01 in treating cystoid macular edema, one of the most important causes of vision impairment following cataract surgery — had already commenced.

Co-Chair of the Oculis Scientific Advisory BoardEric DonnenfeldDr. said"Phase 3Research-OPTIMIZEThe results of the trial are exciting because, compared withPlacebo GroupIn comparison, OCS-01 once daily demonstrated high efficacy in reducing inflammation and pain.Effective and safe with good tolerability. This is very important for patients who have undergone cataract surgery, as they currently need to do it themselves every day.UseMultiple-dose eye drops to reduce inflammation and pain.OnlyOnce dailyDrug AdministrationPreservative-freeTheEye drops, which can benefit a large population worldwideThePatients undergoing eye surgery benefit greatly."

Riad Sherif, CEO of OculisPh.D.Commented: "I amOPTIMIZEThe FrontResultsVery satisfied. Once-daily topical steroid eye drops have shown effectiveness in reducing inflammation and pain.ReliableThe effect, and provides a truly simplified dosing regimen. We areOrderlyAdvanceToFDA SubmissionOCS-01 for Inflammation and Pain Following Ocular SurgeryTheNDAWork. We now have OCS-01Applied in the anterior segment of the eyeTreatment EyeDepartmentPostoperative Inflammation and PainThePhase 3 ClinicalPositive Results，AndOCS-01 Application in Posterior Segment TreatmentDiabetic Macular Edema (DME)ThePhase 3 Clinical Trial - DIAMOND StudyPhase ITheResult,Gives us the first opportunity to applyEye DropsAt the same timeSolveAnterior segment and posterior segmentHighly UnmetClinicalDemand"