Catatan sumber primer
MaterialPerubahan registri uji klinis
Opus Genetics selaras dengan FDA pada desain Fase 3 untuk OPGx-LCA5
FDA Type B RDEP meeting minutes confirm registrational Phase 3 trial design with 8 participants and 6-month primary endpoint. Company may submit BLA based on 6-month efficacy data, with 12-month durability data provided during review. Phase 3 dosing expected to begin Q4 2026.
Fakta utama
- Diajukan
- 6 Jul 2026, 11.00
- Peristiwa
- Perubahan registri uji klinis
- Arah
- Positif
- Perusahaan
IRDOpus Genetics- Aset
- OPGx-LCA5
- Sumber
- Siaran pers perusahaan
- Keyakinan
- Bersumber
- titik akhir primer
- perbaikan rata-rata minimal 7 dB dalam sensitivitas retina di 16 lokus uji sentral
- enrolmen fase3
- 8 peserta
- kekuatan statistik
- >90%
- perbaikan fase1 2
- sekitar 10,5 dB
Kutipan sumber
Opus Genetics Announces FDA Alignment on Phase 3 Registrational Trial Design for OPGx-LCA5 in LCA5-Associated Inherited Retinal Disease Successful Type B RDEP Meeting confirms FDA alignment on pivotal Phase 3 study design FDA indicates Opus Genetics may submit a BLA based on 6-month efficacy data, with 12-month durability data provided during review Company expects to initiate Phase 3 dosing in 4Q 2026 RESEARCH TRIANGLE PARK, N.C., July 06, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc . (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) in
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Penting
12 Nov 2025
12.07
IRDOpus GeneticsOpus Genetics: Pertemuan RMAT FDA telah selesai untuk OPGx-LCA5