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12:00 AM
May 30, 2005
 |  BioCentury  |  Product Development

Reading between the lines

Based on data reported last week, investors concluded that Lucentis from Genentech Inc. and Novartis AG will be the winner over Eyetech Inc.'s Macugen in the treatment of wet age-related macular degeneration (AMD). But EYET is arguing that the patient populations and protocols in the studies - and by extension the results - are not comparable.

DNA (South San Francisco, Calif.) and Novartis (NVS; SWX:NOVN, Basel, Switzerland) reported that after one year, about 95% of patients given Lucentis ranibizumab in a Phase III trial lost less than 15 ETDRS letters, or 3 lines, in visual acuity compared to about 62% in the control arm, the primary endpoint (p<0.0001).

Patients given Lucentis also significantly improved mean visual acuity, a secondary endpoint, while controls experienced a decrease.

Patients in the trial, who will be treated for two years, got 0.3 or 0.5 mg of Lucentis. Control patients received sham intravitreal injections, which involved preparing and anesthetizing the eye but no actual injection.

Patients were allowed to receive Visudyne verteporfin photodynamic therapy from QLT Inc. (TSE: QLT; QLTI, Vancouver, B.C.) and NVS upon a confirmed loss of 20 ETDRS letters compared to baseline, according to Charles Semba, group director of vascular neurology, ophthalmology at DNA.

The 95% result includes both Lucentis dose groups. By comparison, 70% of treated patients and 55% of controls in two Phase II/III trials of Macugen pegaptanib had a loss of less than 15 ETDRS letters. Macugen-treated patients had a mean decline of eight letters in visual acuity, about...

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