for Stargardt disease
Sponsor announced submission . FDA filing review (~60 days) in progress; PDUFA date estimated as acceptance + 10 months Standard Review. Card updates with confirmed dates when FDA acceptance announcement lands.
Stargardt disease is an inherited retinal disorder that causes progressive macular degeneration and vision loss, often beginning in childhood or adolescence. Tinlarebant is an oral drug designed to slow the growth of the damaging lesions in the retina. By limiting this lesion expansion, the treatment could potentially help preserve central vision in affected individuals.
The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1
Source: ClinicalTrials.gov