Genentech: 12-month data shows Lucentis prevents age-related blindness

By Elaine Rigoli

Tampa, Fla., June 2 - Genentech, Inc. announced Friday that a phase 3b clinical study of a quarterly dosing regimen of the investigational drug Lucentis (ranibizumab) for the treatment of age-related blindness met its primary efficacy endpoint by preventing vision loss as measured by mean change in visual acuity from baseline to month 12.

In this study, called PIER, patients received Lucentis (0.3 mg or 0.5 mg respectively) or sham injections once per month for the first three months followed thereafter by doses once every three months for a total of 24 months, according to a news release.

Patients treated with Lucentis, on average, demonstrated an initial increase in mean visual acuity compared to baseline after three monthly injections.

At month three, patients treated with Lucentis, on average, gained 2.9 letters and 4.3 letters (0.3 mg and 0.5 mg dose groups, respectively) compared to a loss of 8.7 letters among patients in the sham group.

After month three, patients treated with Lucentis received additional doses at months six, nine and 12. On average, patients treated with Lucentis returned to baseline visual acuity by month 12, while patients in the sham group experienced significant vision loss.

At month 12, patients treated with Lucentis lost 1.6 letters and 0.2 letters (0.3 mg and 0.5 mg) compared to a loss of 16.3 letters in the sham group, on average, the release said.

"While the PIER regimen provided a 16-letter benefit compared to sham, the data suggest that treating patients on a quarterly basis may be less effective than monthly or individualized dosing. Data from ongoing phase 3b studies and emerging results from our investigator sponsored trials should help us learn more about the optimal dosing regimen for patients," senior vice president of development and chief medical officer Hal Barron said in the release.

The one-year data from this study were submitted to the Food and Drug Administration for consideration as the FDA reviews the Biologics License Application.

Genentech, based in South San Francisco, Calif., is a biotechnology company that develops biotherapeutics for significant unmet medical needs.

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