Clinical Development TimelineDosing pauses and the need to re-enroll a cohort after manufacturing refinements will delay completion of the dose-finding study and postpone the planned top-line readout.
Dose-dependent RiskAdditional inflammation cases at higher cumulative doses, including one requiring topical steroids, signal the possibility of recurring adverse reactions as dosing increases, raising risk for broader patient use.
Safety ConcernsEpisodes of intraocular inflammation linked to residual host cell proteins create material safety uncertainty that could complicate clinical development and regulatory review.