Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye

Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevizye (cyclosporine ophthalmic solution) 0.1%.

The product, if approved, would be indicated for the treatment of moderate to severe dry eye disease in adults who have not seen improvement with the use of artificial tears.

The treatment is marketed in the US by Harrow as Vevye. It was approved by the US FDA in May 2023 and launched in January 2024. Harrow also holds Canadian rights.

Vevizye is a non‑preserved, twice-daily-dosed eye drop based on Novaliq’s water‑free semifluorinated alkane technology. It combines the inhibition of tear evaporation with the anti-inflammatory properties of cyclosporine to treat both the signs and symptoms of dry eye.

Ranibizumab Biosimilar Also Recommended for EU Approval

The CHMP also recommended, on July 25, marketing approval for a ranibizumab (Lucentis) biosimilar from Midas Pharma.

The product, if approved, would be labeled for all five of Lucentis’ indications:

—Wet age-related macular degeneration.

—Diabetic macular edema.

—Proliferative diabetic retinopathy.

—Macular edema due to retinal vein occlusion.

—Visual impairment due to choroidal neovascularization.

Midas’ ranibizumab is a duplicate of Ranivisio, a biosimilar from Formycon that was approved in the EU in August 2022 and is marketed there by Teva.