Genentech's Phase III retinal vein occlusion trial meets endpoint

Fri. July 03, 2009; Posted: 01:11 PM

Jul 03, 2009 (Datamonitor via COMTEX) -- DNA | Quote | Chart | News | PowerRating -- Genentech, a biotechnology company, has reported that the Phase III study Bravo showed Lucentis improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to branch retinal vein occlusion.

According to Genentech, the safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Bravo evaluated the safety and efficacy of six monthly injections of Lucentis compared to monthly sham injections. The two doses of Lucentis studied showed a statistically significant improvement in best-corrected visual acuity at six months compared to sham.

Bravo is a multicenter, randomized, double-masked, sham injection-controlled Phase III study, designed to assess the safety and efficacy of Lucentis in treating macular edema secondary to branch-retinal vein occlusion (RVO). Patients (n=397) were enrolled at 93 clinical trial sites across the US.

The 12-month study consists of a six-month, sham-controlled treatment period, followed by a six-month observation period. During the first six-month period, participants received monthly injections of one of two different doses (0.3mg or 0.5mg) of Lucentis (n=265) or monthly sham injections (n=132).

The study was not designed to compare the two doses of Lucentis. Rescue laser treatment was available starting at month three to all patients meeting pre-specified criteria. The primary endpoint was the mean change from baseline in best-corrected visual acuity score at six months compared to sham.

Hal Barron, chief medical officer of Genentech, said: "RVO is a devastating disease and there are no FDA-approved medicines shown to improve vision for six months. We are excited that another pivotal study has demonstrated the important role Lucentis can play in improving vision in people with difficult-to-treat eye disease, and look forward to the results of Cruise, a Phase III trial in central-RVO in the third quarter of 2009."

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