Clinical Trial Update

WET AMD

Miravant Medical Technologies announced that the new brand name for its SnET2 photodynamic drug is Photrex. Also, last month, the company received an approvable letter from the FDA for Photrex for the treatment of wet AMD. The letter explains conditions for final marketing approval and includes a request for an additional confirmatory clinical trial.

The FDA has granted Fast Track designation to Genaera Corporation's investigational drug, squalamine, an intravenously administered, small molecule antiangiogenic drug for the treatment of wet AMD.

Under the FDA Modernization Act of 1997, Fast Track drug development programs are designed to expedite the review and facilitate the development of a new drug that demonstrates the potential to address unmet medical needs for the treatment of a serious or life-threatening condition.

"Fast Track status will help accelerate the development and commercialization of squalamine," commented Roy C. Levitt, MD, Genaera's president and CEO. "All of our phase II trials for squalamine in AMD are up and running. We anticipate reporting early data from our first phase II study later this year with additional phase II data expected, starting in the first half of 2005. We intend to begin phase III in the first half of 2005 to run concurrently with our largest phase II trial."

UVEITIS
Bausch & Lomb released new data on its Retisert implant for the treatment of noninfectious posterior uveitis, which it says confirms the clinical trial results reported last year. The company reported that in a clinical trial involving 239 patients, at 34 weeks Retisert reduced the uveitis recurrence rate to 10% in treated eyes, compared with a recurrence rate of 55.7% in untreated fellow eyes. In addition, about 21% of the treated eyes had an improvement in vision of 3 or more lines.

The implant combines proprietary drug delivery technology with the steroid fluocinolone acetonide. Adverse events included cataract progression and increased IOP, which were anticipated given the nature of the disease and the type of drug used. These complications were managed by conventional means.

The company anticipates commercialization of Retisert for posterior uveitis sometime next year.