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, presented at the Euretina meeting, “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 compared with laser surgery. The Lucentis 0.2 mg group had an 80% success rate, the Lucentis 0.1 mg group a 75% success rate and the laser surgery group a 66.2% success rate, according to the release.
Lucentis does not damage eye tissue, which is possible with laser surgery, the release said. Instead, it pharmacologically targets and reduces the elevated intraocular level of VEGF, which is the underlying cause of ROP.
“The RAINBOW study is part of our ongoing commitment to addressing the most urgent needs in eye care. We look forward to filing outside the U.S. for an indication in ROP, which may bring us one step closer to reimagining care for these premature infants,” Dirk Sauer, development unit head of Novartis Ophthalmology, said in the release.