Safety profile & toxicology
Cellular cytotoxicity testing in human retinal pigment epithelial cells and observations from a 42-day oral animal study provide preliminary support for tolerability.
Retinal-cell cytotoxicity
Eyevistar was evaluated in human ARPE-19 retinal pigment epithelial cells using an MTT cell-viability assay, with exposure across 7.8 to 1,000 µg/mL for 24 hours. Cell viability remained above 94% across the tested range. At the highest concentration of 1,000 µg/mL, mean viability was 94.08% with calculated cell toxicity of 5.92%. The authors concluded that Eyevistar did not exhibit cytotoxic effects under the tested conditions.
In a 72-hour proliferation assay at 125, 250 and 500 µg/mL, Eyevistar increased ARPE-19 cell proliferation by 33.59%, 46.15% and 62.31% respectively compared with the cell control, supporting cellular compatibility in this in-vitro model.
42 days of daily oral administration
Male rats received Eyevistar orally at 2.5, 5 or 10 mg/kg body weight per day for 42 days while consuming a high-fat diet. The study evaluated body weight, feed intake, organ weights, glucose and lipid profiles, liver enzymes, antioxidant biomarkers, retinal structure and retinal carotenoid deposition.
Eyevistar-treated groups showed reductions in the elevated AST, ALT and ALP levels associated with the model, with the greatest normalization at 10 mg/kg. These observations support tolerability under the study conditions, but the investigation was designed primarily as an efficacy study — not as an acute oral toxicity, 90-day repeated-dose or genotoxicity study.
Heavy metals and contaminant testing
| Test category | Publication status |
|---|---|
| Lead, arsenic, cadmium and mercury | To be confirmed from specification and CoA |
| Pesticide residues | Standard and limits not provided |
| Microbiological quality | Limits not provided |
| Aflatoxins | Limits not provided |
| Residual solvents | Solvent data and limits not provided |
| Ethylene oxide and 2-chloroethanol | Testing status not provided |
Common safety questions
Is Eyevistar safe?
Available preclinical evidence shows high ARPE-19 cell viability at concentrations up to 1,000 µg/mL and provides supportive observations from a 42-day oral animal study. A complete human safety and regulatory toxicology package is not yet available.
Does Eyevistar have known side effects?
The available documentation does not contain completed human adverse-event or side-effect data. Human tolerability conclusions await results from the planned clinical study.
Is Eyevistar tested for heavy metals and contaminants?
No Eyevistar-specific contaminant specification or Certificate of Analysis was included. Current limits and batch results should be confirmed through the approved product specification and CoA.
Request the Eyevistar safety dossier
Our regulatory team can share available documentation and discuss market-specific requirements.