Oculis Holding AG has launched its phase 2b Randomized Evaluation of Licaminlimab’s Efficacy and Safety for Dry Eye Disease (RELIEF) trial on OCS-02 with the first patient first visit (FPFV).
Let’s start with the company.
Headquartered in Switzerland—with U.S. operations based in Boston, Massachusetts—Oculis is a global, clinical-stage biopharmaceutical company focused on developing novel topical treatments for ophthalmic diseases such as retina, dry eye, and neuro-ophthalmology.
Its product candidates include:
- OCS-01, a topical retinal candidate for diabetic macular edema (DME) and inflammation and pain following cataract surgery.
- To note, positive topline data from the DIAMOND study (for DME) was reported in May 2023 (coverage here).
- And more recently, positive data was also reported in the phase 3 OPTIMIZE study (for inflammation and pain) in August 2023 (coverage here).
- OCS-02 (we’ll get to that in a moment)
- OCS-05, a peptidomimetic small molecule with potential neuroprotective properties currently under investigation for acute optic neuritis (AON) as well as:
- Glaucoma
- Diabetic retinopathy (DR)
- Geographic atrophy (GA)
- Neurotrophic keratitis (NK)
Gotcha. Now talk about OCS-02.
Based on a proprietary single-chain antibody fragment (scFv) technology, OCS-02 (licaminlimab) is a new anti-TNFα antibody fragment for topical ocular application.
The compound has a dual mechanism of action—anti-inflammatory and anti-necrosis—that has already been clinically proven with other anti-TNFα antibodies as a systemic treatment for ocular diseases.
So there’s already clinical data on it?
Yup, there is. However, not for DED.
Back in November 2022, positive data from a phase 2 pilot study evaluating OCS-02 for acute anterior uveitis (AAU) was published in Translational Vision Science & Technology.
The trial enrolled 43 participants randomized to receive either OCS-02 (8 drops/day of 60 mg/mL for 15 days, 4 drops/day for 7 days) or dexamethasone drops (8 drops/day for 15 days, tapering to 1 drop/day over 14 days).
And those findings?
The trial met its primary objective—clinical response of ≥2-step decrease in anterior chamber (AC) cell grade at day 15—with OCS-02 administration being well-tolerated in participants for up to 35 days.
See here for more details on those findings.
Gotcha. Now about this RELIEF trial…
The phase 2b study is a multicenter, randomized, double-masked, active-control study (NCT05896670) assessing the safety and efficacy of OCS-02 (vs. a placebo) in treating 120 participants (aged 18+) with moderate-to-severe DED.
To note, the study is in collaboration with ORA, Inc.
What are the treatment doses?
Per Clinical Trials, participants will receive either:
- OCS-02 (60 mg/mL licaminlimab ophthalmic suspension) eye drops, three times a day (TID), for 6 weeks.
- Vehicle of OCS-02 eye drops, TID, for 6 weeks
Note: All patients in both groups will be assigned artificial tears (TID) for 2 weeks.
And what’s being measured?
The primary outcome is to evaluate the efficacy of OCS-02 for DED via their total corneal staining—change from baseline vs vehicle at:
- Pre-controlled adverse environment (CAE)
- Pre-CAE to post-CAE
- Post-CAE
Time period: Baseline to Day 43.
When can we expect results?
The study quite literally just started (on November 29, 2023), and the estimated completion data (According to Clinical Trials) is December 2024.
In the meantime, however, stay tuned for topline data in mid-2024.
And the significance?
OCS-02 (licaminlimab) has the potential to become the first topical anti-TNFα to relieve persistent ocular discomfort for severe DED.