Development And Regulatory RiskClinical, regulatory, financing, and commercial risks could impede development timelines and affect eventual market access for the drug.
Early-stage Pipeline UncertaintyThe early-stage nature of the pipeline creates uncertainty about target indications and competitive positioning until further clinical updates are available.
Evidence Requirement In OphthalmologyA proof-of-concept study in diabetic macular edema is required to confirm retinal effects from oral administration, representing a key development hurdle for expansion into eye indications.