Phase 2 trial shows proof of concept for treatment of geographic atrophy in dry AMD
LINCOLN, R.I. — An implant that releases ciliary neurotrophic factor to the back of the eye effectively stabilized vision in patients with the dry form of age-related macular degeneration involving geographic atrophy.
According to results from a phase 2 trial announced by Neurotech Pharmaceuticals, 96.3% of patients treated with a high dose of product candidate NT-501 lost fewer than three lines of best corrected visual acuity at 12 months compared with 75% of patients in a sham group.
There were no increases in BCVA noted in the study, most likely because of existing photoreceptor damage, and stabilization of BCVA did not reach the level of statistical significance (P = .078), Neurotech said in a statement. However, a dose-dependent increase in retinal thickness was seen on optical coherence tomography (P < .001 and P = .013 for high and low dose, respectively).
No serious adverse events related to NT-501 were reported, and both NT-501 and the surgical procedure were well-tolerated, Neurotech said.
The manufacturer said more phase 2 data will be released in the coming months, and they are developing a second candidate product using the same drug delivery technology to release anti-VEGF therapy to the back of the eye in patients with wet AMD.