Shots:

• The US FDA has approved the EAP program to treat early, intermediate to advanced retinitis pigmentosa (RP) in adults (≥18yrs.) having at least minimal retinal preservation with OCU400 gene therapy 
• The company is conducting P-III (liMeliGhT) study of OCU400 (2.5 x 10^10 vector genomes/eye) for 1yr. in 150 subjects, with arm 1 incl. 75 with RHO gene mutations & arm 2 incl. 75 with other gene mutations. Subjects aged ≥8yrs. with early to late-stage RP are being recruited. The BLA & MAA approval is expected in 2026
• OCU400 is based on the NR2E3 gene which controls photoreceptor development, metabolism, phototransduction, inflammation & cell survival in the retina