Douglas Tsao

Daniil Gataulin

Eddie Hickman

Timothy Chiang

Brian Kemp Dolliver

Edward Woo

Kemp Dolliver

Will Hidell

- **Outlook Therapeutics, Inc.** completed a **Type A Meeting** with the U.S. Food and Drug Administration (FDA) on **September 29, 2025**, to discuss the complete response letter (CRL) for the biologics license application (BLA) resubmission of **ONS-5010**.  **[1649989_0001104659-25-094558_tm2527376d1_ex99-1.htm:0]** **[1649989_0001104659-25-094558_tm2527376d1_8k.htm:1]** 
- Following the discussion, the company **expects to resubmit its BLA before the end of calendar year 2025** for ONS-5010, an investigational ophthalmic formulation of bevacizumab for **wet AMD**.  **[1649989_0001104659-25-094558_tm2527376d1_ex99-1.htm:0]** **[1649989_0001104659-25-094558_tm2527376d1_8k.htm:1]** 
- The original complete response letter from the FDA was dated **August 27, 2025**.  **[1649989_0001104659-25-094558_tm2527376d1_ex99-1.htm:0]** **[1649989_0001104659-25-094558_tm2527376d1_8k.htm:1]**

Outlook Therapeutics Provides Update on FDA Meeting for ONS-5010 BLA Resubmission

- **Outlook Therapeutics** completed a Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter for the biologics license application (BLA) resubmission of **ONS-5010**, an investigational ophthalmic formulation for wet AMD.  **[1649989_1de963ceac074a07b54508b59d1f3f1e_0]** 
- Based on the discussion, Outlook Therapeutics expects to **resubmit its BLA** for ONS-5010 before the **end of calendar year 2025**.  **[1649989_1de963ceac074a07b54508b59d1f3f1e_0]** 
- ONS-5010/LYTENAVA™ has already received Marketing Authorization in the **EU and UK** for the treatment of wet AMD, and commercial launch has commenced in Germany and the UK.  **[1649989_1de963ceac074a07b54508b59d1f3f1e_0]** **[1649989_1de963ceac074a07b54508b59d1f3f1e_1]**

Outlook Therapeutics provides update on FDA meeting for ONS-5010 BLA

- Outlook Therapeutics (OTLK) received a **Complete Response Letter (CRL)** from the FDA regarding its Biologics License Application (BLA) resubmission for **LYTENAVA** for the treatment of wet Age-related Macular Degeneration (AMD).  **[1649989_tx_380447_1]** 
- The CRL identified a single deficiency related to **evidence of efficacy**, specifically that the confirmatory NORSE ONE trial did not meet the FDA's criteria, though the FDA did not state another study is necessary and raised no other issues, including safety or manufacturing.  **[1649989_tx_380447_1]** 
- The company intends to meet with the FDA through a **Type A meeting** in the near term to gain clarity on expectations and determine the best path forward in the U.S..  **[1649989_tx_380447_1]** 
- Despite the U.S. setback, LYTENAVA is already **commercially available in Germany and the UK**, having received marketing authorization in the European Commission and Medicines and Healthcare products Regulatory Agency.  **[1649989_tx_380447_1]**  The company estimates the total European market opportunity at approximately **$600 million**.  **[1649989_tx_380447_3]** 
- Outlook Therapeutics estimates it has **cash for at least the next quarter** (three months) and will focus on cash conservation while continuing its European launch.  **[1649989_tx_380447_1]** **[1649989_tx_380447_6]**  The European business is expected to reach break-even by **early 2026**.  **[1649989_tx_380447_5]**