Harrow reports that it has entered into a definitive agreement with Samsung Bioepis to secure the exclusive US commercial rights to that company's ophthalmology biosimilar portfolio. This includes Byooviz (ranibizumab-nuna), a US Food and Drug Administration (FDA)-approved biosimilar referencing ranibizumab (Lucentis; Genentech), and Opuviz (aflibercept-yszy), an FDA-approved biosimilar referencing aflibercept (Eylea; Regeneron), Harrow said in a press release.

A 2019 agreement gave Biogen the right to market Samsung Bioepis's ranibizumab and aflibercept biosimilars in the United States and Canada; however, in October 2024 Biogen informed Samsung Bioepis it would terminate this deal. Once the transfer of rights back to Samsung Bioepis is complete, Harrow will assume full responsibility for commercialization of Byooviz and Opuviz in the United States. The transition is expected to be completed by the end of 2025, Harrow reported.

Harrow said the strategic acquisition enhances the company's position as a full-spectrum ophthalmic pharmaceuticals provider in the United States, expands its pipeline with high-value biosimilars for sight‑threatening retinal diseases, and reinforces its commitment to delivering value-oriented innovation to the US eyecare market. Byooviz is FDA approved for patients with neovascular (wet) age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization. Opuviz is FDA approved for patients with nAMD, macular edema following RVO, diabetic macular edema, and diabetic retinopathy. RP