Based on FDA feedback, Applied Genetic Technologies (NASDAQ:AGTC) has revised the development plan for its gene therapy for X-linked retinitis pigmentosa, an inherited disorder affecting the retina that leads to vision loss.

Enrollment in the current 30-subject Phase 1/2 trial will be expanded. About 20 patients will be dosed, beginning in Q4, in two masked arms to collect additional functional data, including a mobility test added as a supplemental endpoint.

The agency indicated that a change in visual sensitivity of at least 7 decibels in at least 5 loci would be considered clinically meaningful. The company previously reported visual sensitivity as a mean over an entire treated area. Multiple participants in the Phase 1/2 study would meet the new criteria.

The planned Phase 2/3 trial will include two masked active arms in addition to a control arm. The primary endpoint will be visual sensitivity. Supplemental endpoints will include the mobility test. The study should launch in Q1 2021.

The company will provide additional information in its 10-K filing for fiscal 2020.

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Applied Genetic Tech to expand study of gene therapy for vision loss disorder - Seeking Alpha