Novartis has decided to discontinue development of GT005 (PPY988) in geographic atrophy (GA) secondary to dry-age-related macular degeneration (dry-AMD).
This decision was based on a recommendation from the independent Data Monitoring Committee (DMC) following an overall benefit risk assessment of available data from the program studies, which concluded futility criteria had been met.
the company said it is committed to ensuring patients treated with GT005 (PPY988) are provided with long term safety follow-up
Importantly, no new safety signals were identified.
While Novartis has discontinued the program studies, in a statement the company said it is committed to ensuring patients treated with GT005 (PPY988) are provided with long term safety follow-up.
“Our disappointment in this outcome is first and foremost for the GA community. We are subsequently communicating with study investigators, Health Authorities and relevant bodies and are committed to sharing information from these early studies with the ophthalmology and scientific communities to help inform future development of gene therapies. We sincerely thank the study participants and the investigators for their participation,” the release said.
