- Oculis Holding AG is advancing its neuroprotective candidate, **Privosegtor**, into registrational trials for acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION) following a positive meeting with the FDA.  **[1953530_0001193125-25-231973_d891485dex991.htm:0]** **[1953530_0001193125-25-231973_d891485d6k.htm:1]** 
- The company will launch the **PIONEER program**, which includes three pivotal trials: PIONEER-1 (AON) starting in **Q4 2025**, PIONEER-2 (AON) in **1H 2026**, and PIONEER-3 (NAION) in **mid-2026**.  **[1953530_0001193125-25-231973_d891485dex991.htm:0]** **[1953530_0001193125-25-231973_d891485d6k.htm:1]** **[1953530_0001193125-25-231973_d891485dex992.htm:1]** 
- Privosegtor is positioned as a potential **first-in-class neuroprotective therapy** for AON and NAION, addressing high unmet medical needs in these rare neuro-ophthalmic diseases.  **[1953530_0001193125-25-231973_d891485dex991.htm:0]** **[1953530_0001193125-25-231973_d891485dex991.htm:2]** **[1953530_0001193125-25-231973_d891485dex992.htm:2]** **[1953530_0001193125-25-231973_d891485dex991.htm:3]** 
- As of **September 30, 2025**, Oculis reported preliminary unaudited cash, cash equivalents, and short-term investments of approximately **$182 million**, with a cash runway expected into **2H 2027** to support the Privosegtor development program.  **[1953530_0001193125-25-231973_d891485d6k.htm:1]** **[1953530_0001193125-25-231973_d891485dex992.htm:1]**

Oculis Advances Privosegtor into Registrational Trials

- Oculis Holding AG announced a **successful meeting with the U.S. FDA**, allowing its neuroprotective candidate **OCS-05** to advance into the registration phase for **acute optic neuritis (AON)** and **non-arteritic anterior ischemic optic neuropathy (NAION)**.  **[1953530_2168809_0]** **[1953530_2168809_1]** 
- The company plans to initiate the **Pioneer 1** registration trial for AON in **Q4 2025**, followed by **Pioneer 2** in the **first half of 2026**, and **Pioneer 3** for NAION in the **mid of 2026**.  **[1953530_2168809_1]** **[1953530_2168809_3]** 
- Oculis anticipates a readout for its **OCS-01** eye drop for Diabetic Macular Edema (DME) in **Q2 2026**.  **[1953530_2168809_1]** **[1953530_2168809_4]** 
- OCS-05 targets significant market opportunities, with AON estimated at **over $3 billion** and NAION at **over $4 billion** in the U.S..  **[1953530_2168809_3]** 
- The company maintains a **strong balance sheet with no debt** and a cash runway extending into the **end of 2027**.  **[1953530_2168809_1]**

Oculis Holding Provides Update on OCS-05 Development Plan and Clinical Trial Timelines

- Oculis successfully concluded a meeting with the U.S. FDA, enabling the advancement of its **Privosegtor** candidate into registrational phases for **Acute Optic Neuritis (AON)** and **Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)**.  **[1953530_2168542:6]** 
- The **PIONEER-1** registrational trial for AON is slated to commence in **Q4 2025**, with **PIONEER-2** following in **1H 2026**, and the **PIONEER-3** trial for NAION expected to start in **mid-2026**.  **[1953530_2168542:6]** 
- Readouts for **OCS-01 eye drops** in Diabetic Macular Edema (DME) are anticipated in **Q2 2026**, with a New Drug Application (NDA) submission targeted for **2H 2026**.  **[1953530_2168542:5]** **[1953530_2168542:10]** 
- Oculis reports a **strong balance sheet with no debt** and a **cash runway extending into 2H 2027** without utilizing its loan facility.  **[1953530_2168542:5]**

Oculis Holding (OCS)