Shares of Opus Genetics, which focuses on inherited retinal diseases, reached a 52-week high as it reported favorable drug study data and a successful meeting with the Food and Drug Administration.

The stock was recently up 26% to $5.46 and is up about 171% this year. Shares peaked at $7.07 Wednesday.

Opus reported three- and six-month results from the low-dose Cohort 1 of a Phase 1/2 clinical trial evaluating OPGx-BEST1 in patients with retinal diseases including Best vitelliform macular dystrophy and autosomal recessive bestrophinopathy.

All five participants demonstrated clinically meaningful improvement in visual function, with structural improvements observed in four participants, the company said. OPGx-BEST1 demonstrated a favorable safety and tolerability profile with no serious adverse events or dose-limiting toxicities observed.

The company met with the FDA to discuss OPGx-BEST1 development and potential endpoints for a pivotal clinical trial, and aligned with the agency on a potential endpoint and Phase 3 and commercial manufacturing requirements.

Opus expects to begin planning for the Phase 3 trial immediately, with participant dosing expected to begin in 2027.