Laru-zova Shows Promise in X-Linked Retinitis Pigmentosa Trial
News related to:Beacon Therapeutics · 3 min read
Beacon Therapeutics today announced positive topline results from its pivotal VISTA trial evaluating laruparetigene zovaparvovec (laru-zova) for the treatment of X-linked retinitis pigmentosa (XLRP). The trial met its FDA-endorsed primary endpoint, demonstrating statistically significant low luminance visual acuity (LLVA) responder rates at Month 12 compared to the untreated control group. A statistically significant proportion of trial participants in both the high and low dose groups achieved an improvement of ≥15 letters in LLVA as compared to no responders in the untreated control group. Specifically, the high dose group responder rate was 31.0%, p=0.0019, and the low dose group responder rate was 24.1%, p=0.0106.
The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period. The trial evaluated a high dose group of 6.8 E+11 vg/eye and a low dose group of 3.7 E+11 vg/eye. The VISTA trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group.
The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group.
The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group.
In a press release, the chief executive, Doe, the chief executive, said she was pleased with the result. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group.
In a press release, the chief executive, Doe, the chief executive, said she was pleased with the result. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group.
In a press release, the chief executive, Doe, the chief executive, said she was pleased with the result. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in the low dose group, and 3.7% in the high dose group. The pivotal trial evaluated 85 male subjects aged 12 to 48 over a 12-month period, with 48.3% of participants achieving a ≥10 letter improvement in LLVA compared to the untreated control group, and 58.6% in