One year after treatment, eyes of bilaterally injected patients experienced an average gain from nadir[1] in best-corrected visual acuity (BCVA) equal to +23 ETDRS letters, greater than the 18-letter average gain among patients with only one eye injected. In both groups, the clinical improvement exceeded the conventional definition of clinical meaningfulness, in which a 15-letter gain is considered meaningful. The safety profile of the gene therapy continues to be favorable and comparable between bilaterally treated patients and unilaterally treated patients.
The results were presented at the 2024 annual meeting of the
One year after treatment, responder analyses show that the visual improvements accrue to the majority of patients: 63.2% of the eyes of bilaterally injected patients reached a clinically meaningful level of improvement in BCVA (0.3 LogMAR or +15 ETDRS letters), as did 57.9% of eyes of unilaterally injected patients. Nine months after injection, the average visual acuity corresponded to on-chart vision, compared to off-chart average visual acuity at baseline.
The safety results obtained in the EAPs were consistent with those observed in the clinical studies, showing a favorable safety profile of lenadogene nolparvovec. Notably, intraocular inflammation events reported in LUMEVOQ-treated eyes were comparable in frequency, intensity, and location to those observed in the clinical studies.
'Witnessing results like these energizes the GenSight team's drive to restore early access availability for eligible patients by Q3 this year,' said
LUMEVOQ (GS010; lenadogene nolparvovec) was made available through EAPs in selected countries based on unsolicited requests from clinicians and where authorized for early access use by local regulations in those countries. The Company aims to resume early access in
Contact:
Email: itortet@gensight-biologics.com
Tel: +41 (0)76 735 01 31
Email: gvanrenterghem@lifesciadvisors.com
(C) 2024 Electronic News Publishing, source