Douglas Tsao

Daniil Gataulin

Eddie Hickman

Timothy Chiang

Brian Kemp Dolliver

Edward Woo

Kemp Dolliver

Will Hidell

- 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]**