Dompé announced the first patient has been enrolled in a phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the phase 3 trial, Galassia-NAION-301 is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION, the company said in a press release.
The study will enroll approximately 272 people globally with NAION aged 50 to 80 years. The study endpoints will assess functional and structural changes in the affected eye, as measured by best corrected visual acuity, visual field testing, and optical coherence tomography. Cenegermin-bkbj is an investigational product for NAION, and its safety and efficacy for this indication have not been established or approved by any regulatory authority, the company said in the press release.







