ANI Pharma posts preliminary Q2 ILUVIEN/YUTIQ revenue of $22.3M; NEW DAY trial misses primary endpoint

ANI PHARMACEUTICALS INC

Preliminary combined ILUVIEN/YUTIQ net revenues for Q2 2025: $22.3M.
NEW DAY trial primary endpoint: mean supplemental injections 2.4 (ILUVIEN) vs. 2.5 (aflibercept); p=0.756, not significant.
Secondary endpoint met: mean time to first supplemental injection 185.4 vs. 132.8 days (p<0.001).
Post-hoc per-protocol analysis: ILUVIEN arm 1.8 vs. 2.5 supplemental injections (p=0.029); total 2.8 vs. 7.5 injections.
Safety: 41% treatment-related TEAE in ILUVIEN arm (cataract, IOP increase) vs. 3% in aflibercept arm.

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