Opus Genetics Reports 24-Month OPGx-LCA5 Vision Gains; Phase 3 Dosing Set for Q4 2026
IRD has more than doubled off its 52-week low of $1.7.
Summary
Opus Genetics presented new data showing OPGx-LCA5 vision improvements sustained through 24 months in adults and six months in children, with Phase 3 dosing expected in Q4 2026. OPGx-BEST1 showed retinal sensitivity gains in 75% of evaluable low-dose patients, and high-dose Cohort 2 is now fully enrolled.
Key Events · Product Development and Regulatory · IRD
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OPGx-LCA5 24-Month Data Positive
In the Phase 1/2/3 trial, three adults sustained visual acuity and light-sensitivity improvements through 24 months, while three pediatric participants improved through six months.
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Phase 3 Dosing Expected Q4 2026
The OPGx-LCA5 Phase 3 natural history and treatment cohorts are fully enrolled; dosing initiation is expected in Q4 2026, with a primary endpoint of >7 dB mean retinal sensitivity improvement across 16 central loci.
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BEST1 Cohort 2 Fully Enrolled
Enrollment is complete for the high-dose Cohort 2 of the OPGx-BEST1 Phase 1/2 BIRD-1 trial, with 11 participants; low-dose Cohort 1 showed retinal sensitivity improvement in 3 of 4 evaluable participants (75%).
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New Structural Endpoint Analyses
OCT-derived EZ-to-RPE thickness and hyperautofluorescence correlated with retinal sensitivity, informing prespecified microperimetry loci for future trials.
Analysis · IRD · Life Sciences
At Retina in Rio 2026, Opus presented new clinical data for both lead gene therapy programs. The substantive addition is the OPGx-LCA5 update: three adults sustained visual acuity and light-sensitivity improvements through 24 months, and three pediatric participants improved through six months, with participants reporting functional gains such as navigating without a cane. The Phase 3 natural history and treatment cohorts are fully enrolled, dosing is expected to begin in Q4 2026, and the primary endpoint is a mean retinal sensitivity improvement of more than 7 dB across 16 central test loci. For OPGx-BEST1, the company reported improved retinal sensitivity in three of four evaluable low-dose Cohort 1 participants (75%) and disclosed that high-dose Cohort 2 enrollment is complete with 11 participants. The BEST1 data were largely reported in September; the new elements here are the LCA5 durability data, the Phase 3 timeline and endpoint, and the completed Cohort 2 enrollment. These are interim results from small cohorts, so the read-through to a pivotal outcome remains unproven.
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