SparingVision announced the completion of dosing in its phase 1/2 PRODYGY clinical trial evaluating SPVN06, the company’s novel gene-agnostic therapy for the treatment of retinitis pigmentosa (RP).

A total of 33 patients were enrolled in the PRODYGY trial, including 27 patients dosed with SPVN06 since April 2023 and six patients randomized to an untreated control group. Primary endpoint analysis will occur after all patients have completed at least 1 year of follow-up, with an initial data readout expected in 2027.

“This is an important milestone in our goal to transform the treatment landscape for patients with RP,” said Dr. Kali Stasi, Chief Medical Officer of SparingVision. “By sustaining the natural function of photoreceptors, SPVN06 has the unique potential to preserve visual acuity and color vision in degenerative retinal diseases such as RP, regardless of genetic mutation or cause of the disease. This could potentially benefit patients from diagnosis until cone photoreceptors remain functional."

SPVN06 is SparingVision’s first adeno-associated virus (AAV)-based gene therapy designed to preserve vision in patients with degenerative retinal diseases. Unlike gene-specific therapies, SPVN06 takes a gene-agnostic approach by protecting cone photoreceptors through neuroprotective effects on cone metabolism that aim to slow or halt degeneration.

According to SparingVision, the therapy has potential applications across multiple retinal conditions in which cone photoreceptor loss leads to blindness, including inherited retinal diseases (IRDs) such as RP, as well as non-inherited conditions such as age-related macular degeneration (AMD).

SparingVision plans to begin sharing data with regulatory authorities in 2026, with the aim of initiating a pivotal trial in 2027.