Ocugen announces publication of Phase 1 GARDian1 trial results for OCU410ST

Ocugen (OCGN) announced the publication of positive Phase 1 GARDian1 trial results for OCU410ST, its novel modifier gene therapy for Stargardt disease, in the peer-reviewed journal Nature Eye-published by the Royal College of Ophthalmologists. The Phase 1 GARDian1 trial demonstrated robust efficacy and safety outcomes supporting the clinical development of OCU410ST. Key Findings include: Among six patients with gradable Fundus Auto Fluorescence images, atrophic lesion growth was reduced by 54% (0.55 +/- 0.27 mm) in treated eyes, compared to untreated fellow eyes (1.19 +/- 0.31 mm) over 12 months. Lesion expansion was 50% slower (0.10 +/- 0.039 mm/year) in treated eyes versus untreated eyes (0.19 +/- 0.026 mm/year), below published natural history rates (0.14-0.18mm/year).Among six BCVA-evaluable patients without confounders, treated eyes gained +6 letters in BCVA (+4.5 letters) compared to a -1.5 letter decline in untreated fellow eyes at 12 months. 100% of treated eyes either stabilized (+/-4 letters) or improved (greater than or equal to5 letters) in visual acuity. No drug-related serious adverse events or adverse events of special interest were observed