Clarity Needed on Particulates in Ophthalmic Drugs Quality Guidance Say Stakeholders

Topical ophthalmic drug developers have asked the FDA for greater clarity on evaluating visible particulate matter, extractables and leachables, and petitioned the agency for more specifics on quality issues, as the comment period closed Monday on a revised guidance for such products.

The draft guidance, “Quality Considerations for Topical Ophthalmic Drug Products,” originally issued in October 2023, covers any FDA-regulated drug products that are used for topical delivery around the eye, such as solutions, suspensions, emulsions, gels, ointments or creams. In December 2023, the agency revised the 17-page guidance to add microbiological considerations related to product sterility.

But many drugmakers have still expressed concerns that more changes are needed to clarify the FDA’s position, in the wake of product contamination safety recalls related to over-the-counter eye drop products which resulted from various safety concerns including infections, partial loss of vision and blindness.

Read the comments on the revised draft guidance here.

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