Oculis

• Oculis has successfully enrolled over 800 patients across 119 global sites in its DIAMOND Phase 3 trials evaluating OCS-01, the first-ever topical eye drop treatment for diabetic macular edema. • The DIAMOND program represents a potential paradigm shift in DME treatment, offering a non-invasive alternative to current therapies that require intravitreal injections or ocular implants. • Topline data from both Phase 3 trials is expected in Q2 2026, with NDA submission to follow, potentially addressing the needs of millions of patients with this leading cause of vision loss in diabetics.

• Oculis announced the expansion of Privosegtor (OCS-05) development beyond acute optic neuritis to include non-arteritic anterior ischemic optic neuritis (NAION) and acute relapses in multiple sclerosis patients. • The company has completed enrollment of over 800 patients in two Phase 3 DIAMOND trials for OCS-01 eye drops in diabetic macular edema, with topline data anticipated in Q2 2026. • Licaminlimab (OCS-02), a topical anti-TNFα biologic, is advancing with a genotype-based personalized approach for dry eye disease, with Phase 2/3 studies expected to begin in the second half of 2025.

• Oculis' OCS-05 demonstrates significant neuroprotective effects in acute optic neuritis patients, showing preserved retinal ganglion cells and reduced multiple sclerosis relapses in Phase 2 ACUITY trial. • The company's lead candidate OCS-01, utilizing OPTIREACH® technology, progresses in Phase 3 trials for diabetic macular edema, offering potential non-invasive alternative to intravitreal injections. • Oculis develops OCS-02, a TNF inhibitor with biomarker-driven approach for dry eye disease, representing a shift toward precision medicine in ophthalmic treatment.

• Oculis Holding AG's OCS-05 met the primary safety endpoint and achieved statistically significant results in key secondary efficacy endpoints in the ACUITY trial. • The Phase 2 trial evaluated OCS-05 in patients with acute optic neuritis, demonstrating a favorable safety profile compared to placebo. • Treatment with OCS-05 resulted in significant improvements in retinal structure and visual function, suggesting neuroprotective benefits. • The FDA has cleared the IND application for OCS-05, enabling clinical development in the U.S. as part of a global program.

• Oculis reports significant progress in its product pipeline, notably in the OCS-01 Phase 3 DIAMOND program for diabetic macular edema (DME) and the OCS-05 Phase 2 ACUITY trial for acute optic neuritis (AON). • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in AON in December 2024, which will provide insights into the safety, tolerability, and neuroprotective potential of OCS-05. • Oculis's leadership team has been strengthened with key appointments, and the company's cash reserves of $125.0 million are expected to fund operations into the second half of 2026. • The company plans to be NDA submission ready in Q1 2025 for OCS-01 for post-operative pain and inflammation, following a pre-NDA meeting with the FDA in August 2024.

• Oculis reports significant progress in its product pipeline, notably in the Phase 3 DIAMOND program for DME with OCS-01 and the Phase 2 ACUITY trial for AON with OCS-05. • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis in December 2024, offering insights into its neuroprotective potential. • Oculis is preparing for an NDA submission for OCS-01 in post-operative pain and inflammation by Q1 2025, following a pre-NDA meeting with the FDA. • With a strong cash position of $125.0 million, Oculis expects to fund operations into the second half of 2026, supporting its clinical development programs.

• Oculis reports significant progress in its product pipeline, including enrollment in the OCS-01 DIAMOND Phase 3 program for diabetic macular edema (DME). • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON) in December 2024. • Oculis' cash, cash equivalents, and short-term investments totaled $125.0 million as of September 30, 2024, funding operations into the second half of 2026.

Oculis Holding AG reports accelerated enrollment in its DIAMOND Phase 3 trials for OCS-01 eye drops to treat diabetic macular edema (DME).

• Oculis is halting the Phase III OPTIMIZE-2 trial of OCS-01 eye drops for post-cataract surgery due to a third-party administrative error that compromised data analysis. • The FDA has indicated that data from the Phase III OPTIMIZE-1 trial and Phase II SKYGGN study are sufficient to support a New Drug Application (NDA) for OCS-01. • OCS-01 is being developed for post-operative inflammation and pain following ocular surgery, as well as diabetic macular edema (DME). • The NDA submission for OCS-01, which would be Oculis’ first, is planned for the first quarter of 2025.