USA – FDA releases draft guidance on dry eye therapies

A new draft guidance from the US Food and Drug Administration (FDA) addresses considerations for developing drugs to treat dry eye. The guidance encompasses development of both pharmaceutical and biological products to address the common eye condition.

The best trial design, said FDA, is a per-patient randomized, double-masked trial that looks for superiority of an investigational product over the control, which could be the vehicle. Either a traditional environmental exposure trial or a trial design that uses an environmentally controlled chamber could be acceptable; trials where the investigational drug is add-on therapy to standard of care are also acceptable, according to the guidance…