Question · Q4 2022
Sung, on behalf of Tom Shrader at BTIG, asked how the priority review for ADX-2191 in ocular lymphoma might benefit other indications like PVR and retinitis pigmentosa, and also inquired about the strategy for the new visual acuity data from the Reproxalap safety trial.
Answer
President and CEO Dr. Todd Brady explained that securing approval for ocular lymphoma first was a deliberate strategy, as it establishes the drug's safety and manufacturing profile, potentially lowering the bar for subsequent supplemental NDAs. He noted the strong safety data from the Phase 3 GUARD trial supports this. Regarding visual acuity, Dr. Brady stated the remarkable data from the 12-month safety trial will be included in the 120-day safety update to the FDA and serves as a key market differentiator.