New article: Are inactive ingredients in eye drops safe? A closer look at excipients safety, function an regulation.
What are excipients and what role do they play in eye drops?
When using eye drops, most people focus on the active ingredient—the component that treats the condition. However, most medications also contain “inactive” ingredients called excipients. While they don’t directly treat diseases, excipients play a crucial role in making medications more effective and comfortable for patients.
One example is hyaluronate sodium, a common ingredient in eye drops. Although it doesn’t have a direct therapeutic effect, it helps the solution stay in the eye longer and prevents dryness by acting as both a thickening agent and a lubricant.
Are excipients always safe?
Despite their importance, excipients don’t always receive the same level of scrutiny as active ingredients. Research on their safety isn’t always comprehensive, and there have been occasional reports of allergic or toxic reactions. This presents a challenge for regulatory agencies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), which typically approve excipients as part of a complete drug formulation rather than evaluating them individually. As a result, up-to-date safety information on excipients can be difficult to find and FDA is one of the few organisations which maintains a comprehensive list of approved inactive ingredients in human medicines.
To address this gap, the Restore Vision team at INSERM, conducted a study reviewing excipients used in FDA-approved eye medications. This research is particularly relevant to the team’s work in developing new eye drop formulations for treating rare eye diseases. Before new treatments can be tested in clinical trials, researchers must ensure that all ingredients—both active and inactive—are safe and suitable for human use.
About the study
This is the first comprehensive review ofFDA-approved excipients in ophthalmic medications, examining their roles, safety, and the regulatory pathways required for approval for human use.
The study highlights that excipients make up the largest portion of most medications and serve essential functions. However, contrary to the belief that they are always inactive, some excipients can influence how a drug works or even cause side effects, making rigorous safety evaluation critical before regulatory approval.
As the Restore Vision team is working on new eye drop formulations, understanding the role and safety of excipients is essential. The study can help researchers develop safer and more effective treatments while also providing valuable insights for regulators and healthcare professionals.
Read the full paper
https://www.sciencedirect.com/science/article/pii/S093964112500013X