Oculis Holding AG has announced the first patient visit in its phase 3 OPTIMIZE-2 trial evaluating OCS-01 for the treatment of inflammation and pain following cataract surgery.
Quick refresh on the company.
Oculis is a global, clinical-stage biopharmaceutical company focused on developing novel topical treatments for ophthalmic disease in therapeutic areas such as retina, dry eye, and neuro-ophthalmology.
And its clinical pipeline?
Here’s the rundown:
- OCS-01 (we’ll get to that in a moment)
- OCS-02
- Dry eye disease (DED)
- OCS-05
- Glaucoma
- Diabetic retinopathy (DR)
- Geographic atrophy (GA)
- Neurotrophic keratitis (NK)
Wait… didn’t we just have an update from Oculis?
We did! The company initiated the second stage of its phase 2b RELIEF trial on OCS-02 for DED. See our coverage here.
Ok, now tell me more 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 (SNP) technology—a proprietary platform that allows drugs to be formulated as non-invasive topical treatments, with a longer residence time on the ocular surface, thereby increasing absorption into certain ocular tissues.
Isn’t OCS-01 being evaluated for another eye disease?
Yup. It’s also in clinical trials (NCT0506697 [DIAMOND]; NCT05608837 [LEOPARD]) for the treatment of diabetic macular edema (DME) and cystoid macular edema (CME).
Click here to read positive topline data from the DIAMOND study, reported in May 2023.
Moving on… wasn’t there an original OPTIMIZE study?
Yup. 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 phase 3 study evaluating OCS-01 for post-cataract surgery inflammation and pain.
The company previously reported positive data from the first phase 3 study in August 2023.
And those findings?
OCS-01 was found to be 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.
Gotcha. How is this new trial set up?
Similar to the OPTIMIZE-1 trial, the study is examining once-daily OCS-01 vs vehicle for 2 weeks.
Primary endpoint: The absence of anterior chamber cells on Day 15 and absence of pain on Day 4.
So when can we expect results from this new trial?
Oculis anticipates a topline readout before the end of 2024.
The end goal: To use the study’s data to support a new drug application (NDA) submission to the FDA.
And the significance?
OCS-01 has the potential to become the first once-daily, topical, preservative-free corticosteroid for treating patients with inflammation and pain following cataract surgery.
This drug candidate could represent a possible new standard in surgical care.