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Investing,com -- Bayer (OTC:BAYRY) shares rose over 2% on Friday after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended a label extension for Eylea 8 mg, allowing for longer treatment intervals for patients with two major retinal diseases.
The CHMP opinion supports expanded dosing intervals of up to six months for aflibercept 8 mg, a treatment for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The extension is contingent on a final decision from the European Commission, which is expected in the coming weeks.
If approved, Eylea 8 mg would become the only anti-vascular endothelial growth factor (anti-VEGF) treatment in the EU authorized for six-month intervals for both nAMD and DME, according to Bayer’s statement Friday.
“Following approval of the European Commission, extended treatment intervals with Eylea 8 mg of up to 6 months can significantly reduce the frequency of injections and visits to the clinic for patients,” said Christine Roth, executive vice president, Global Product Strategy and Commercialization at Bayer.
The CHMP recommendation is based on three-year data from the PULSAR and PHOTON clinical trials. In these open-label extension studies, 24% of nAMD patients and 28% of DME patients who started with Eylea 8 mg at baseline were on six-month treatment intervals by the end of year three.
Eylea 8 mg maintained the patients’ vision and anatomic outcomes over the study period, Bayer said.
The safety profile remained consistent with that of the already-approved 2 mg dose, with no new safety signals reported.
Eylea 8 mg is already approved in more than 50 markets, and further regulatory submissions are under review in additional countries. In the EU and U.K., Eylea 8 mg is the only anti-VEGF treatment currently approved for up to five-month intervals after three initial monthly injections.