Karpecki PM, et al. - A sum of 16 candidates were involved in this phase 1, open-label, single-center, single-arm, study to assess the ocular safety of OTX-101 0.09% – a novel, nanomicellar, clear, aqueous solution of cyclosporine (CsA) and also to define the systemic exposure to CsA after ophthalmic regime. They observed 3 subjects with a CsA concentration higher than or equal to the lower limit of quantitation (LLOQ) on day 1 whereas, on day 8, only 4 cases had 3 continuous CsA concentration measurements ≥LLOQ. An AUC_(0–t) was recorded as 0.53±0.06 h·ng/mL whereas the mean±SD for C_max, 0.17±0.02 ng/mL. Adverse events (AEs) including eye pain, eye pruritis, and eye irritation were noticed during the study. Overall, the OTX-101 formulation was reported well tolerated.