May 2008 Issues

American Thoracic Society (ATS)

Summary: IPF: Data from a Japanese trial showed InterMune/Shionogi’s pirfenidone effective in preserving vital capacity, but the trial had a high dropout rate, and the side effects – especially photosensitivity – could be problematic. The U.S. pivotal trial has a slightly different endpoint – FVC instead of VC – but the FDA also wants to see a mortality trend or benefit. ♦ PAH: United Therapeutics’ inhaled Viveta met the primary endpoint in its pivotal trial, but doctors weren’t sure that the improvement in 6-minute walk was as robust as they would like to see clinically, though Viveta is easier to administer than Actelion’s Ventavis. ♦ PK data on United Therapeutics’ oral Remodulin suggest it may turn out to be both effective and safe, though some patients may need TID rather than BID dosing, and patients may need individualized titration. ♦ Drugs approved for other indications that appear promising in PAH: Bayer’s Nexavar and Novartis’s Gleevec. ♦ COPD: Forest/Almirall’s aclidinium appears comparable in efficacy and safety to Pfizer’s Spiriva, but it failed to differentiate itself except in terms of the delivery device, which is very slick – but Spiriva will soon have an interesting new device as well. ♦ Pneumonia is a risk with inhaled corticosteroids, but that is not a barrier to new combination products, and the risk is unlikely to require longer or larger trials.

Eye Care Update #2 -- Quick Pulse

Summary: To check on trends in the eye care field, 41 optometrists, mostly from Florida , were interviewed at the Dade County Optometric Association’s Miami Nice Education Symposium in Coral Gables on April 19 and 20, 2008. They offered opinions and outlooks on the economy, contact lenses, contact lens solutions, refractive surgery, and glaucoma and dry eye medications.