May 2007 Issues

FDA Approves Continuous Birth Control Pill -- Quick Pulse

Summary: The FDA approved Wyeth’s Lybrel, concluding that it is safe and effective as a contraceptive, but Lybrel may not get the approval of many women. The problem with Lybrel is that two-thirds of women continue to have spotting or bleeding for an average 4-5 days a cycle. Wyeth will be required to conduct a Phase IV postmarketing study, but the details of that study have not been worked out.

New Study Finds Significant Heart Attack Risk with Diabetes Drug -- Quick Pulse

Summary: A Vioxx-Type Controversy with GlaxoSmithKline’s Avandia?  GlaxoSmithKline’s diabetes drug, Avandia (rosiglitazone), has all the elements of a bad novel: A drug used by millions of people worldwide, data that the drug is dangerous, the company defending it amid suggestions of a cover-up, an uncertain FDA, and a congressional committee investigating.

Heart Rhythm Society ( HRS )

Summary: ICD volume is flat and likely to remain that way for at least the next year – or until something (e.g., some new technology) gives the market a kick. ♦ ICD market shares are relatively stable. There is slightly more interest in St. Jude’s products, but Boston Scientific/Guidant is not expected to rebound for another 6-12 months because doctors want to be sure the problems and recalls really are over. ♦ Interest is growing in remote monitoring of ICDs, but all the major companies have fairly comparable devices, so this is not driving market share. ♦ T-wave alternans testing as a method of selecting ICD patients remains very controversial. ♦ Robotics was a hot topic, and doctors expect robotic ablation to become standard-of-care in 5-10 years. Adoption is still slow because of the cost, but it is picking up somewhat. ♦ CryoCath’s CryoBalloon is attracting interest, and doctors are interested in trying it – when and if there are data establishing its efficacy.

FDA Advisory Committee Recommends New Studies, Tougher Labeling for Anemia Drugs

Summary: The FDA’s Oncologic Drugs Advisory Committee recommended the Agency: ♦ Restrict the label even further for anemia drugs. ♦ Require additional safety trials for already approved products. ♦ Define a hemoglobin level in asymptomatic patients in which ESAs should be initiated. ♦ Restrict ESA use in certain tumors. ♦ Not require dose titration. The FDA’s Cardio-Renal Advisory Committee will meet in the fall to consider use of ESAs in renal patients. Shortly after the panel meeting, and partly in reaction to it, CMS announced initiation of a National Coverage Decision that will reduce and limit reimbursement for these drugs in cancer patients.

Association for Research in Vision and Ophthalmology (ARVO)

Summary: OSI /Eyetech’s Macugen is trying to find a place in the U.S. as maintenance therapy for wet AMD in conjunction with Genentech’s Avastin or Lucentis, but many retinal specialists were dubious that the company can hang on long enough and convince enough doctors – and payors – that this is the right approach. ♦ DME trials no longer must be three years; a 2-year trial may be acceptable to the FDA if two statistical hurdles are met. ♦ It appears the FDA may let Allergan change the primary endpoint in the second Phase III memantine glaucoma prevention trial (and without a statistical penalty). ♦ Corneal staining is not raising significant concerns. The increase in Acanthamoeba keratitis is being blamed on changes in residential water treatment processes and poor patient contact lens hygiene, not contact lens materials or solutions. Differences in the various contact lens solutions are viewed mostly as marketing ploys. ♦ Regeneron’s VEGF-Trap may find a role in AMD despite the success of Avastin and Lucentis. ♦ Two products to watch: SurModics’ I-vation implant for DME and Othera Pharmaceuticals’ OT-551, a topical therapy for AMD.

American Society of Cataract and Refractive Surgery (ASCRS)

Summary: LASIK procedure volume is flat and likely to remain that way this year, and surgeons are dubious about presbyLASIK. ♦ Multifocal IOL use is flat and unlikely to pick up without new and better technology. Cost, physician issues, lack of consumer awareness, and lack of a “wow” factor are limiting use. ♦ Acanthamoeba keratitis appears due to changes in water treatment, not corneal staining, silicone hydrogel lenses, or differences in contact lens solutions, none of which kill it. ♦ Some experts are excited about new corneal inlays, especially those from AcuFocus, but the data are very limited and early. ♦ Increasingly, a femtosecond laser is a must-have, for marketing purposes if nothing else, and AMO/IntraLase remains the 900-pound gorilla, but there is still a market for other femtosecond lasers, and Ziemer has started making U.S. sales. 20/10 Perfect Vision and Zeiss are not yet selling their femtosecond lasers in the U.S. ♦ China is a growing but challenging market, and companies are having varying degrees of success there.