Breaking News: Formycon AG Announces Phase III Clinical Trial Enrollment

Phase III Lotus Trial to Evaluate Biosimilar Lucentis Treatment

Highlights:

• Formycon AG, a leading biosimilar developer, has enrolled the first patient in its Phase III Lotus clinical trial.
• The trial will assess the safety and efficacy of FYB202, a biosimilar of the anti-VEGF drug Lucentis (ranibizumab).
• Lucentis is used to treat various ophthalmic conditions, including wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

The Lotus trial will involve approximately 1,100 patients with wet AMD or DME, and will compare the safety and efficacy of FYB202 to Lucentis.

Formycon believes that FYB202 has the potential to provide a more affordable and accessible treatment option for patients with these debilitating eye conditions.

"We are excited to initiate this Phase III trial, which represents a significant milestone in our development of FYB202," said Dr. Stefan Glöckner, Chief Medical Officer of Formycon AG. "We look forward to the results of this trial, which we expect to provide further support for the potential of FYB202 as a treatment option for patients with wet AMD and DME."

The Lotus trial is expected to be completed in 2026, with results expected to be available in 2027.