FDA Issues Guidance for Topical Ophthalmic Drugs

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The draft guidance document discusses quality considerations for topical ophthalmic drug products.

FDA published draft guidance on Oct. 11, 2023, Quality Considerations for Topical Ophthalmic Drug Products, that discusses quality considerations for topical ophthalmic drug products used in and around the eye. These types of products include solutions, suspensions, emulsions, gels, ointments, and creams.

The document specifically outlines approaches for evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. It also discusses in vitro drug release/dissolution testing for certain ophthalmic dosage forms. FDA also offers recommendations for design, delivery, and dispensing features of container closure systems (CCSs) and stability studies.

Regarding visible particulate matter, the guidance states, “For topical ophthalmic drug products packaged in opaque containers, appropriate technologies (e.g., X-ray spectroscopy) or destructive testing should be used to identify particulates within the accepted visible size range.”

In discussing extractables and leachables, the document states, “Leachables have the potential to interact with the formulated drug product, which could compromise product quality and therapeutic effect. The assessment of extractables and leachables should consider the primary, secondary, and tertiary packaging components of the CCS, including the labeling components.”


For in vitro drug release and dissolution testing, FDA states, “One approach that applicants can consider as part of the quality control strategy for certain ophthalmic dosage forms (e.g., suspensions, emulsions, semi-solids) is the use of in vitro drug release/dissolution testing. Other approaches are also acceptable, such as using one or more critical quality attributes (CQAs) that are sensitive to the formulation and process variants. The applicant should provide scientific justification for how the control strategy will ensure consistent product quality.”

In addition, the guidance document provides information about United States Pharmacopeia criteria and recommendations for documentation of chemistry, manufacturing, and controls information for new drug applications, abbreviated new drug applications, and biologics license applications. However, the guidance does not apply to biological products regulated by the Center for Biologics Evaluation and Research.

Source: FDA