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© 2004
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Silicone Breast Implants - Quick Pulse
Summary: The day after issuing a non-approvable letter to Inamed for its silicone breast implant, the FDA issued a draft of a revised guidance document for manufacturers of breast implants. This document updates previous guidance issued in February 2003. The key issue appears to be continuing concern over silicone implants that rupture.
IMRT and IGRT update
Summary: IMRT use is continuing to grow, and hospitals have added this capability to most if not all of their linear accelerators. IMRT is being used for an average of 44% of patients. Medicare reimbursement cuts do not appear to be affecting IMRT use or orders. IMRT systems are considered fairly comparable, and hospitals continue to be willing to mix and match accelerators and IMRT planning systems. IGRT is the hot new radiation oncology product. It is considered both very important and very time consuming, and most new LINACs are expected to be equipped with IGRT. Doctors said it’s too early to tell how Varian’s Trilogy and Elekta’s Synergy stack up.
American Academy of Ophthalmology
Summary: LASIK volumes are up year-over-year, but have not returned to pre-September 11th levels, and the outlook for 12%-15% more procedures in 2004 than 2003. Custom cornea has really caught on, but many doctors are not convinced it improves outcomes. Non-LASIK vision correction options – conductive keratoplasty, phakic IOLs, clear lens exchange, etc. – are getting a lot of attention. The new AMD drug closest to market appears to be Eyetech’s Macugen. Pooled data from 2 Phase II/III trials indicated Macugen is effective, safe, and works in all lesion types. Questions were raised about the pooled analysis, but if Macugen gets FDA approval, sources expect widespread use both as monotherapy and in combination with QLT’s Visudyne and other future agents. Bristol-Myers Squibb’s Kenalog continues to be widely used off-label to treat AMD, uveitis and macular edema.
Eyecare Update
Summary: Allergan’s Restasis for dry eye is expensive, but use is expected to double over the next year. Allergan’s Lumigan is expected to pick up a little glaucoma market share in 2004 at the expense of Pfizer’s Xalatan, with Alcon’s Travatan holding steady. Optometric referrals for LASIK surgery have picked up due to custom cornea/wavefront and increased advertising, and that trend is expected to continue, but doctors are not convinced there is a significant difference in outcomes with custom LASIK. Most toric lenses today are disposables, and toric use is expected to continue to increase, with Bausch & Lomb’s SofLens 66 the leader. Alcon is the company considered most likely to succeed over the next year. The overall opinion of B&L continues to deteriorate, while opinions of Novartis/CIBA Vision and CooperVision improved. Allergan, CIBA and Vistakon are viewed as having the best sales reps.
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