Encouraging Phase 2 results for Oculis’ eye drops for Dry Eye Disease

In the US alone, there is currently between 16 million and 49 million people who have dry eye disease. Significant unmet medical needs remain for this large and growing patient population with only 9% of diagnosed patients in the US receiving treatment and despite current options, only 13% of patients are achieving lasting relief.

The results of a double blinded, multicenter and placebo controlled Phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on global ocular discomfort in patients with severe dry eye disease (DED) (NCT02365519) has now been published by the Clinical Ophthalmology journal. Primary and secondary efficacy endpoints were successfully met and showed superiority of licaminlimab over vehicle for the relief of ocular discomfort in patients with severe DED.

Christophe Baudouin, M.D., Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, Paris, commented: “There is a true unmet medical need for the development of drugs with new mechanism of action to treat the inflammation involved in the pathogenesis of DED. OCS-02 is certainly one that could fill that gap. As compared to currently available treatment options and other product candidates in the DED pipeline, OCS-02 could play a role in the treatment of the underlying causes of the disease given its anti-inflammatory and anti-necrosis benefits. I certainly look forward to the continued development and approval of OCS-02 in severe dry eye disease as these patients currently have limited treatment options.”

Riad Sherif, M.D., CEO of Oculis, said: “The Phase 2 data further reinforce our confidence in the potential of OCS-02 as a novel anti-inflammatory treatment for the effective management of Dry Eye Disease, but also for other inflammatory eye diseases. With Phase 2b clinical trials of OCS-02 for the treatment of dry eye disease and uveitis which are planned to start in the coming months, along with on-going Phase 3 clinical trials of OCS-01 in diabetic macular edema and inflammation and pain following ocular surgery and a proof-of-concept (POC) trial of OCS-05 in acute optic neuritis, we look forward with confidence to the further development of the Oculis Ophthalmology Franchise to address significant unmet medical needs in key areas of ophthalmology.”

(Press release / SK)