CEO tells J.P. Morgan conference that he is confident the pivotal EMBARK study can be completed in 2022 with regulatory filing in 2023.

The 2021 collaboration between Abbvie and Regenxbio to develop an anti-VEGF gene therapy for chronic retinal diseases is a noteworthy deal in the gene therapy space. But for both clinical and commercial reasons, it is a one-off opportunity and not an indicator of the overall potential of gene therapies to address eye diseases. Interest in optogenetics, however, which is the introduction of light-sensing genes into cells in the eye to restore vison, may be on the rise.

Two outside groups aim to help CBER on gene therapy questions from ‘N of one’ to markers for hemophilia.

AbbVie had no presence in ophthalmic medicine other than a single indication for Humira before the Allergan merger, but now has a growing eye care portfolio, including early FDA approval of Vuity for presbyopia.