Lucentis ranibizumab: Phase III data

In the double-blind, sham injection-controlled, sham laser-controlled, international Phase III RESTORE trial in 345 patients, 0.5 mg intravitreal Lucentis with or without laser therapy met the primary endpoint of significantly improving mean BCVA score from baseline to 12 months vs. laser therapy alone (by 5.9 and 6.1 letters, resectively, vs. 0.8 letters, p<0.0001 for each). Additionally, Lucentis with or without laser therapy had improved vision by >=10 letters on the study eye chart in 43% and 37% of patients, respectively, vs. 16% for laser therapy alone. No cases of endophthalmitis were reported and the incidence of increased intraocular pressure was <1%. Data were presented at the European Association for the Study of Diabetic Eye Complications meeting in Paris. ...