FDA Pipeline preview, September 2008

The FDA has approved VIZZ, a once-daily, preservative-free eye drop that improves near vision in adults with presbyopia for up to 10 hours.

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.

Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.

Health policy researcher Geoffrey Joyce argues that only delinking compensation from the list price of a drug will lower drug spending.

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.