Clinical Trial Timeline RiskA dosing pause and the need to re-enroll a patient cohort will delay trial completion and postpone the planned top-line readout, increasing development timeline risk.
Inflammation Requiring Medical InterventionSome patients experienced inflammation that required topical steroid treatment, highlighting the risk of adverse reactions at higher cumulative dosing.
Intraocular Inflammation Safety SignalOccurrences of intraocular inflammation have created a clear safety concern that may lead to increased monitoring and scrutiny from regulators.