New positive data from Oculis’s phase 2 clinical trial assessing topical licaminlimab (OCS-2) on the anterior chamber cell grade in patients with acute anterior uveitis (AAU) has been published in Translational Vision Science & Technology.
What is OCS-2?
OCS-2 (licaminlimab) is a new anti-TNFα antibody fragment for topical ocular application. With a dual mechanism of action—anti-inflammation and anti-necrosis—it’s already been clinically proven with other anti-TNFα antibodies as a systemic treatment for ocular diseases.
Tell me about the trial.
The trial included 43 participants randomized to receive either OCS-2 (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 dop/day over 14 days).
The primary endpoint was a clinical response of ≥2-step decrease in anterior chamber (AC) cell grade at day 15. (via)
What did they find?
The trial met its primary objective with OCS-2 administration being well-tolerated in participants for up to 35 days.
Data showed 56% of OCS-2 treated patients had at least a 2 grade reduction in AC cells from baseline on day 15 and 76% had an AC cell grade of 0 in at least one visit.. Intraocular pressure did not increase for OCS-2.
The take home.
If approved, OCS-2 could become the first topical anti-TNFα for the treatment of non-infectious anterior uveitis. It could also make a difference in addressing the need for a steroid-sparing agent and a topical biologic to be designated specifically for noninfectious anterior uveitis without the associated systemic risks.
Oculus is in the planning stages for phase 2b clinical trials of OCS-2 to treat noninfectious anterior uveitis and dry eye disease.