Oculis Holding AG has released positive topline data from its phase 3 Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops (OPTIMIZE) trial assessing OCS-01 eye drops for the treatment of inflammation and pain following ocular surgery.
Refresh me on OCS-01
OCS-01 is designed as a novel, high concentration (15 mg/ml), topical ophthalmic formulation of dexamethasone that utilizes Oculis’s proprietary OPTIREACH technology (more on that below).
Aside from inflammation and pain post-ocular surgery, the once-daily (QD) and preservative-free formula is currently being evaluated for the treatment of diabetic macular edema (DME) (NCT05066997) as well as cystoid macular edema (CME).
To note, Oculis reported positive topline data for the phase 3 DIAMOND trial on OCS-01 for DME back in May 2023. Read about that here.
Speaking of data … didn’t we just have an update on OCS-01?
Indeed! But that was for the treatment of CME… the first patient was enrolled in its investigator-initiated, randomized, and controlled LEOPARD study (NCT05608837) for CME.
Gotcha. Now this OPTIREACH technology.
The OPTIREACH solubilizing nanoparticle technology is a proprietary platform that permits drugs to be formulated as non-invasive topical treatments with a longer duration of time on the ocular surface—thereby increasing absorption into certain ocular tissues.
The result: less frequent dose administration and burden to the ocular surface as well as potentially improved drug penetrance for treating posterior segment eye diseases.
And this phase 3 study?
The randomized, double-masked, placebo-controlled trial (NCT05147233) enrolled 241 patients (ages 18+) at 25 sites across the United States.
What determined patient eligibility?
Patients had to be planning to undergo unilateral cataract extraction by phacoemulsification and posterior chamber intraocular lens (PCIOL) implant in the study eye, as well as:
A pinhole visual acuity without any other correction > 20 letters in the operated eye and >35 letters in the non-operated eye (measured using the Early Treatment for Diabetic Retinopathy Study [ETDRS] chart at Visit 1, prior to surgery).
How about the dosages?
Patients were randomized 1:1 to receive either QD OCS-01 (n = 119) or vehicle (n=122) for 14 days following cataract surgery.
What was measured?
The primary efficacy endpoints included the absence of inflammation at Day 15 and the absence of pain at Day 4.
And the findings?
OCS-01 met both primary endpoints, with a statistical significance observed in inflammation and pain.
Specifically, the number of OCS-01-treated eyes with no inflammation was statistically significantly greater than vehicle-treated eyes at Day 15 (57.2% vs 24%, respectively, p < 0.0001).
Similarly, the number of OCS-01-treated eyes with no pain was statistically significantly greater than vehicle-treated eyes at Day 4 (75.5% vs 52%, respectively, p < 0.0001).
What about IOP changes?
Oculis reported no meaningful difference in intraocular pressure (IOP) between the treatment groups, with a mean change from baseline to Day 15 of -0.90 mmHg for both OCS-01 and vehicle groups.
So overall … ?
Overall, OCS-01 was found to be well-tolerated with a favorable safety profile, demonstrating superiority in the reduction of both inflammation and pain compared to vehicle following cataract surgery.
Any safety concerns?
A few… but the number of ocular treatment emergent adverse events (TEAEs) reported for vehicle-treated eyes was greater than for OCS-01-treated eyes by more than 50% (n = 84 vs n = 37).
And the significance?
From a big-picture perspective, if OCS-01 is approved, it has the potential to become the first once-daily, topical, preservative-free corticosteroid for treating patients with inflammation and pain post-cataract surgery—representing a possible new standard of care for this patient base.