Ocuphire successful End-of-Phase 2 meeting with FDA for oral APX3330 in diabetic retinopathy

Opus Genetics, Inc.

FDA agreed on Phase 3 primary endpoint: ≥3-step worsening on binocular DRSS; SPA to be submitted.
APX3330 could be first oral option for ~8M US NPDR patients; Phase 2 ZETA-1 showed slowing of DR progression.
Company plans Special Protocol Assessment to finalize trial design and timing with FDA.
Phase 2 ZETA-1 met primary endpoint: lower % of APX3330-treated patients had ≥3-step worsening vs placebo at 24 weeks.
APX3330 demonstrated favorable safety/tolerability; CEO calls it 'most advanced oral therapy in development for DR'.

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