Novartis to seek ROP indication for Lucentis

Novartis announced it will file for a new indication for Lucentis for the treatment of retinopathy of prematurity, according to a company press release.
The filing will be based on the “favorable benefit-risk profile” of the phase 3 RAINBOW study of Lucentis (ranibizumab, Novartis/Genentech) vs. laser surgery for the treatment of ROP in premature infants.
The study “marginally” missed statistical significance for its primary endpoint (P = .0254, compared with the significance level of P = .025), the difference in success between the Lucentis 0.2 mg and 0.1 mg groups

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