Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2002
No articles may be reproduced without written permission of the publisher.
Return Home
Eyecare Update
Summary: Optometrists are excited about Allergan's Restasis, and usage is likely to ramp quickly and strongly, limited only by cost. Allergan's Lumigan and Alcon's Travatan will continue to take market share from Pfizer/ Pharmacia's Xalatan. Refractive surgery (LASIK) procedures have not picked up, and no improvement is expected until the economy improves - which doctors are dubious will occur this year. In the contact lens area, Johnson & Johnson/ Vistakon may have the most momentum over the next 6-12 months, but CooperVision is likely to be the biggest winner among these doctors. Novartis/CibaVision and Ocular Sciences should see some pickup in business, but doctors could find little good news for Bausch & Lomb.
The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
Summary: The proposed Concept Document on QT is likely to morph into a formal guidance document very quickly - and with only minor changes. The FDA views any drug with a mean QT prolongation of >20 ms as having a problem - unless proven otherwise. The FDA is uncertain whether it is appropriate and safe to lower the dose of a proposed new drug to keep a QT effect to a minimum. When the rules are finalized, the FDA likely will require a QT comparator arm - something like Bayer's Avelox (moxifloxacin) -- in every Phase I trial for every new drug. The FDA is not ready to accept the theory that the area under the curve in QT prolongation (the area of transmural dispersion of repolarization) can predict the likelihood of a QT prolongation leading to Torsade de pointes.
1879 Avenida Dracaena, Jensen Beach, FL, 34957, 772-334-7409, Fax 772-334-0856
Email webmaster about site: snyderk577@aol.com
