Oculis Announces Positive Phase 2 Results for Licaminlimab (OCS-02) in Acute Anterior Uveitis Published in TVST

· Positive data show that the anti-TNFα drug licaminlimab eye drops can reduce the inflammatory response in acute anterior uveitis (AAU), achieving the primary efficacy endpoint of this study.

· Peer-reviewed journal articles highlight the potential of licaminlimab to become a new non-steroidal topical treatment for anterior uveitis.

· Licaminlimab eye drops were well tolerated, with no significant ocular or non-ocular safety issues identified.

Lausanne, Switzerland, November 22, 2022 — Oculis S.A. (Oculis), a global ophthalmology company developing breakthrough innovations to advance life-changing treatments to save sight and improve eye care, announced the results of a randomized, multicenter, parallel-group, active-controlled Phase II clinical trial evaluating the effect of licaminlimab (OCS-02) eye drops on anterior chamber (AC) cell grading in patients with acute anterior uveitis (AAU) (NCT02482129) have been published in Translational Vision Science & Technology (TVST), AN ARVO JOURNAL. The study, titled "Topical Anti-TNFα Agent Licaminlimab Eye Drops for Acute Anterior Uveitis: A Randomized Phase II Exploratory Study," is available on the U.S. National Institutes of Health (NIH) website.here.

The Results Show Efficacy in Treating AAU Patients Against Predefined Criteria

Uveitis is a general term describing a group of inflammatory diseases that cause swelling and destroy eye tissues. These conditions can mildly reduce vision or lead to severe vision loss. Corticosteroids are the main current treatment, usually applied locally, but depending on the extent and severity of the disease, they may also be used periocularly or systemically. Corticosteroid treatments, whether local, periocular, or systemic, can lead to increased intraocular pressure, thereby raising the risk of glaucoma and cataracts.

Licaminlimab (OCS-02) is an anti-TNFα antibody based on innovative antibody fragment technology, enabling its local administration via eye drops. Its dual mechanism of action (MoA) includes anti-inflammatory and anti-necrotic effects, which have been clinically validated by other approved anti-TNFα antibodies for systemic administration in the treatment of ocular diseases. Its MoA also demonstrates transformative potential in other therapeutic areas. If approved, Licaminlimab (OCS-02) may become the first locally administered anti-TNFα biologic eye drop approved for the treatment of non-infectious anterior uveitis, significantly addressing the medical need for non-steroidal treatments for this condition.

Oculis is currently planning to conduct a Phase 2b clinical trial of licaminlimab (OCS-02) for the treatment of non-infectious anterior uveitis and dry eye disease (DED).

"There is a clear medical need for non-steroidal anti-inflammatory therapies for uveitis. This is particularly important for patients requiring long-term anti-inflammatory treatment, as long-term steroid therapy is not optimal due to associated side effects. The recently published positive results demonstrate the potential of OCS-02 as a topical non-steroidal treatment for non-infectious anterior uveitis. The planned clinical trial of OCS-02 as a non-steroidal treatment for recurrent or chronic anterior uveitis is crucial, as its unique properties can provide maximum benefit to patients," said Dr. Anat Galor, Professor of Ophthalmology at the University of Miami Health System.

Dr. Riad Sherif, CEO of Oculis, said: "These positive data further enhance the potential of licaminlimab. If approved, OCS-02 will become the first topical biologic eye drop for treating anterior uveitis, offering a non-steroidal treatment option for patients and doctors worldwide in a field with high medical need. Oculis currently plans to conduct two Phase II clinical trials in 2023 to further evaluate this breakthrough drug candidate for treating chronic anterior uveitis and dry eye disease. For these inflammatory conditions, we believe it also has great potential to provide doctors with a new option for treating their patients."

About Oculis

Oculis is an international ophthalmology company that utilizes breakthrough technologies and revolutionary therapies to improve vision and protect eyes. Oculis's highly differentiated products and technologies include candidates for localized retinal treatments, topical biologics, and disease-modifying therapies. With its operations in key international markets, Oculis is well-positioned to provide life-changing treatments to patients around the world. Headquartered in Lausanne, Switzerland, Oculis has a presence across Europe, the United States, and China, and is led by experienced professionals.ManagementTeam leader, and supported by leading international healthcare investors.