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Oculis releases positive phase 3 data from OPTIMIZE-1 trial for post-op inflammation and pain

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Oculis S.A. announced positive data from the phase 3 OPTIMIZE-1 study investigating OCS-01 eye drops for the treatment of inflammation and pain following cataract surgery.

The results were presented by Eric Donnenfeld, MD, during the 2024 American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting earlier this month.

Let’s start with OCS-01.

As Oculis’s lead investigational candidate, OCS-01 is formulated as a novel, high-concentration (15 mg/ml), topical drug candidate of dexamethasone that utilizes Oculis’ OPTIREACH solubilizing nanoparticle technology.

More about this tech: The OPTIREACH solubilizing nanoparticle (SNP) technology is a proprietary platform designed to enable the formulation of drugs as non-invasive topical treatments.

Its potential: to extend these non-invasive topical therapies’ residence time on the ocular surface as well as enhance bioavailability in relevant eye tissues.

And what makes OCS-01 unique?

Per Dr. Donnenfeld, OCS-01 offers two specific advantages over conventional eye drops (which typically require multiple daily doses):

  • A highly concentrated formulation 15 times the concentration of current FDA-approved dexamethasone eye drops
  • Improved solubility profile to enhance eye tissue penetration

Now this phase 3 study.

The Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops (OPTIMIZE-1) study (NCT05147233) is a multi-center, randomized, double-masked, vehicle-controlled study.

Participant info: A total of 241 patients (ages 18+) were enrolled at 25 sites across the United States.See here for participant criteria.

The setup: Patients were randomized 1:1 to receive either QD dosing of OCS-01 (n = 119) or vehicle (n=122) for 14 days following cataract surgery.

The outcome measures: absence of inflammation at Day 15 and the absence of pain at Day 4.

Didn’t the company already report findings?

They did! Back in August 2023, positive data was released.

The findings: OCS-01 was well-tolerated with a favorable safety profile while demonstrating superiority in reducing both inflammation and pain (vs vehicle) following cataract surgery.

See our coverage here.

And this new data?

According to Oculis, a total of 57.2% of “OCS-01-treated patients were inflammation free (i.e. absence of anterior chamber cells [ACC]) at Day 15.”

This compared to 24% of vehicle (placebo)-treated patients (p<0.0001).

How many reported ocular pain?

At Day 4, 75.5% of OCS-01-treated patients reported an absence of ocular pain—compared to 52% of patients treated with vehicle (p<0.0001).

Gotcha… now, aren’t there other trials on OCS-01?

There are! And not just for postop pain and inflammation …

The 52-week, DIAMOND-1 and DIAMOND-2 phase 3 trials (NCT05066997) are investigating OCS-01 for the noninvasive treatment of diabetic macular edema (DME).

Both studies are currently ongoing, with positive topline data from stage 1 of the DIAMOND study was reported in May 2023 and, more recently, the first patient was dosed in stage 2 in January 2024.

Plus, in August 2023, the company reported the first patient was enrolled in an investigator-initiated study (NCT05608837) assessing OCS-01 for cystoid macular edema (CME).

And for postop pain and inflammation?

Another phase 3 study (OPTIMIZE-2) (NCT05147233) was just launched in December 2023. Similar to the OPTIMIZE-1 trial, the study is examining once-daily OCS-01 vs vehicle for 2 weeks.

See here for details.

So when can we expect another data readout?

According to Oculis CEO Riad Sherif, MD, topline data from the second phase 3 OPTIMIZE-2 study is expected before the end of 2024.

The intent: for the OPTIMIZE trials to support an eventual new drug application (NDA) submission.

And the overarching significance?

As a potential new treatment therapy, OCS-01 could become the first once-daily, topical, preservative-free corticosteroid for treating patients with inflammation and pain post-cataract surgery.

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