Retinitis pigmentosa treatment receives fast track designation
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The FDA granted fast track designation to MCO-010 from Nanoscope Therapeutics for the treatment of retinitis pigmentosa.
The ambient light activatable multi-characteristic opsin optogenetic monotherapy is administered by intravitreal injection to patients with retinitis pigmentosa who have advanced vision loss. Topline data from the RESTORE clinical trial of MCO-010 in 27 patients with retinitis pigmentosa are expected in the first half of 2023.
In addition, Nanoscope recently completed enrollment in the phase 2 STARLIGHT clinical trial of MCO-010 in patients with advanced vision loss due to Stargardt disease. Six-month data are expected in the first half of 2023.
“The FDA’s decision to grant [fast track designation] underscores the importance of MCO-010 to address a serious unmet need and validates its potential as an effective therapeutic for patients with [retinitis pigmentosa],” Sulagna Bhattacharya, CEO of Nanoscope, said in a press release. “We are proud to have the support of the FDA and look forward to collaboratively interacting with FDA to assess next steps in the clinical development and future regulatory review of MCO-010.”
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