Oculis Holding AG announced enrollment completion for the phase 3 Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops (OPTIMIZE) trial assessing the safety and efficacy of OCS-01, its investigative formulation, for treating post-cataract surgery inflammation and pain.
Tell me about OCS-01.
OCS-01 is designed as a once-daily, novel, high-concentration, preservative-free, topical formulation of dexamethasone.
It was developed using Oculis’s OPTIREACH solubilizing nanoparticle technology—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 eye tissues.
In addition to post-cataract surgery inflammation and pain, OCS-01 is currently also being evaluated for the treatment of diabetic macular edema (DME) (NCT05066997).
What happened in the phase 2 study?
In the SKYGGN trial (NCT04130802), OCS-01 was well tolerated and met its primary and secondary endpoints, which included the absence of anterior chamber cells and pain, respectively.
A statistical significance was achieved in patients receiving a once-daily or twice-daily dosing of OCS-01 compared to vehicle. See here for further details.
Now talk about this phase 3 study.
The randomized, double-blind, placebo-controlled trial (NCT05147233) enrolled 240 patients (ages 18+) at 25 sites across the United States. Efficacy measures will be the absence of pain (Day 4) and absence of inflammation (Day 15).
What patients were eligible for recruitment?
Patients must 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).
When can we expect results?
According to the study’s Clinical Trials data, estimated completion is June 2023. So stay tuned!