Oculis presents positive Phase 2 data for a second disease

The results of an active-controlled, multicenter, randomized, parallel-group Phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on anterior chamber (AC) cell grade in patients with acute anterior uveitis has been published in Translational Vision Science & Technology.

Uveitis is a general term describing a group of inflammatory diseases that produces swelling and destroys eye tissues. These diseases can slightly reduce vision or lead to severe vision loss. In the United States alone, there are more than 300,000 Americans suffering from non-infectious uveitis. Anterior uveitis is the most prevalent type accounting for 85% of this patient population and about half of the cases are considered to be either recurring or chronic. Corticosteroids are the current mainstay of therapy, however corticosteroid therapy, whether topical, periocular, or systemic, can lead to increased IOP, which increases the risk of glaucoma, and cataracts.

Oculis' Licaminlimab (OCS-02) is an anti-TNFα antibody product candidate based on an innovative antibody fragment technology allowing it to be administered topically. If approved, licaminlimab (OCS-02) has the potential to become the first topical anti-TNFα to be approved for treatment of non-infectious anterior uveitis, and could help address the significant medical need for a steroid-sparing agent and for a topical biologic to be indicated specifically for non-infectious anterior uveitis without the associated systemic risks.

The Phase 2 Pilot study met its primary objective according to prospectively specified criteria, in the treatment of patients with Acute Anterior Uveitis (AAU), and thereby established evidence of treatment effect. The data showed a response rate on Day 15 of 56% for licaminlimab-treated patients, defined as a reduction from baseline in AC cell grade of ≥2 (SUN). Secondary and exploratory endpoints in the study were also supportive of the treatment effect of licaminlimab (OCS-02) eye drops, with most patients demonstrating a reduction of ≥2 units from baseline in AC cell grade by day eight, with few patients requiring rescue therapy, most patients achieving an AC cell grade of zero in at least one visit, and the median change from baseline in AC cell grade being equivalent to responder status. Licaminlimab (OCS-02) was observed to be well tolerated, including no increase in intra-ocular pressure related to licaminlimab (OCS-02).

Phase 2b clinical trials of licaminlimab (OCS-02) for the treatment of non-infectious anterior uveitis, as well as dry eye disease (DED), are currently being planned by Oculis.