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FDA OKs label update
The FDA has approved a new label update tied to Genentech’s ranibizumab (Lucentis) prescribing information for wet age-related macular degeneration (AMD).
San Francisco-The FDA has approved a new label update tied to Genentech’s ranibizumab (Lucentis) prescribing information for wet age-related macular degeneration (AMD).
The revised label is based on the 24-month study data from the HARBOR trial for wet AMD patients.
Key findings from the study data include:
· Of patients receiving less frequent than monthly treatment, 93% did not require monthly injections.
· The average injection frequency over 2 years for the patients was 9.9 weeks, with a mean best-corrected visual acuity gain of 7.9 letters.
“The label update, which is the third in the past 18 months, represents Genentech’s commitment to rigorous science, as well as the company’s dedication to keep physicians informed about the clinical data that impacts their patients,” said Allison Neves, senior manager, product public relations, Genentech.
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