Opus Genetics, Inc.

The presbyopia market across seven major markets is forecast to grow from approximately USD 11 billion in 2025 to nearly USD 18 billion by 2036, a compound annual growth rate of 4.9 percent. The United States accounted for about half of the total market in 2025 and is expected to remain the largest region. Presbyopia eye drops generated roughly USD 3 billion across the seven major markets in 2025, reflecting rising demand for noninvasive pharmacological treatments. Eyeglasses represented around half of US presbyopia market revenue in 2022 and are projected to stay the leading treatment category through 2036. The treatment landscape is shifting from conventional optical correction toward prescription therapies, with approved products including VUITY, QLOSI, and YUVEZZ, while late-stage pipeline candidates from Eyenovia, Opus Genetics and Viatris, and Glaukos Corporation may further reshape competition.

Opus Genetics has reached alignment with the FDA on the design of its registrational Phase 3 clinical trial evaluating OPGx-LCA5 for LCA5-associated inherited retinal disease. The company received meeting minutes from a Type B Rare Disease Evidence Principles meeting confirming that it may submit a Biologics License Application based on efficacy at the six-month primary endpoint, with 12-month durability data submitted during the BLA review process. The Phase 3 study is expected to enroll eight participants, seven of whom have already been enrolled and are completing the run-in period, with dosing expected to begin in the fourth quarter of 2026. In pre-market trading on NasdaqCM, Opus Genetics shares rose 2.55 percent to $4.3378.

RBC Capital initiated coverage of Opus Genetics with an Outperform rating and a $10 price target, citing limited competition, de-risked science, and recent FDA leniency. The firm highlighted upcoming BEST1 data in September and four additional clinical readouts expected in 2027. Opus Genetics recently detailed three new programs entering clinical testing, alongside LCA5 data showing maintained visual acuity improvement over 24 months in adults, with pivotal Phase 3 dosing set for the fourth quarter of 2026. The company also completed first-cohort dosing for BEST1 in May 2026, with topline data due in September, while OPGx-RDH12 and OPGx-MERTK are slated to begin clinical testing in late 2026 and early 2027. Shares have risen nearly 110% year-to-date as of July 2, 2026.

Opus Genetics announced that dosing in the Phase 3 trial for its gene therapy OPGx-LCA5 is expected to begin in the fourth quarter of this year. The company also provided updates on its broader pipeline of gene therapies for inherited retinal diseases, including OPGx-RDH12, for which clinical testing is set to begin in the fourth quarter of this year. OPGx-MERTX and OPGx-RHO are expected to enter clinical testing in 2027 and the second half of 2027, respectively. The Phase 1/2 trial for OPGx-BEST1 completed patient dosing in May 2026, with three-month topline data anticipated in September 2026.