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FDA official offers perspective on treatments vs. cures
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FORT LAUDERDALE, Fla. — Difficult questions face companies looking to develop new treatments for ophthalmic conditions and for those who hope to have their agents approved by the FDA, a speaker said here.
Sustained-release therapies, therapies that block additional factors and gene therapies hold great promise as treatments, but they raise difficult questions about how they should work, how they should be introduced to a patient and how they address the signs and symptoms of the condition they are treating, Wiley Chambers, MD, an ophthalmologist with the FDA Center for Drug Evaluation and Research, said in a keynote address at the Retina World Congress.
“Why do we have treatments? Maybe because it’s easier to treat than cure. Treatments are often aimed at looking at the signs and symptoms of a condition, not looking at the condition itself. Sometimes they only affect part of the condition but don’t treat the entire thing,” he said.
Future sustained-release therapies, therapies that block additional factors of a condition and gene therapies all face similar challenges. These categories of potential therapies face duration of treatment challenges, including if the therapy will “be enough” for a patient and if the patient will eventually develop a compensatory mechanism to overcome the therapy.
“We have the same questions. What concentration is the right concentration? Will adding additional factors be enough? Will there be compensatory mechanisms? That becomes the job of the FDA to ask these questions and you certainly won’t answer them all in a single trial, but we try raising these questions now, so people can start addressing these various issues,” Chambers said.
The goal of the Center for Drug Evaluation and Research is not to block the pathway to new treatments, but to assure the availability of safe and effective products and to give patients safe and effective choices of products, Chambers said.
“I recognize these are hard questions, but if somebody doesn’t ask them, I’m not sure anyone will try to answer them. And just because there are questions doesn’t mean we shouldn’t be trying to answer them,” he said. – by Robert Linnehan
Reference:
Chambers W. Keynote lecture: Treatments versus cures: An FDA perspective. Presented at: Retina World Congress; March 21 to 24, 2019; Fort Lauderdale, Fla.
Disclosure: Chambers reports no relevant financial disclosures.