This article is more than 5 years old. Information may no longer be current.
Novel molecule shows promise for future treatment of neovascular AMD
Click Here to Manage Email Alerts
SAN DIEGO — A higher dose of a novel small molecule under development offers potential as a future treatment for neovascular age-related macular degeneration, according to early results of a phase 2 dose-escalation study.
Pravin U. Dugel, MD, told colleagues at the American Society of Retina Specialists annual meeting that ESBA 1008 met its primary endpoint of noninferiority at week 4 vs. ranibizumab (Lucentis, Genentech) in two of its highest doses being assessed for safety and tolerability.
A single injection of ESBA 1008 0.5 mg, 3 mg, 4.5 mg or 6 mg or a single injection of ranibizumab 0.5 mg was administered to 194 patients in the prospective, randomized, multicenter study.
Pravin U. Dugel
"After the 1-month mark, there is a tendency toward increased [central subfield] thickness in the ranibizumab group,” Dugel said.
There was not such a tendency in the high-dose ESBA 1008 group, suggesting a longer duration of action for the novel molecule, he said. Furthermore, there were numerically greater mean gains in best corrected visual acuity for the 6 mg ESBA 1008 dose at week 4 than for the 0.5 mg ranibizumab dose (10.4 letters vs. 6.5 letters, respectively).
Median time to receiving standard of care was 30 days longer for patients who received 6 mg of ESBA 1008 compared with patients who received ranibizumab 0.5 mg.
At the end of the day, perhaps the most important thing about ESBA 1008 is the potential to package this very small molecule into a sustained drug-delivery device capable of delivering the largest amount of volume to the target tissue while minimizing systemic exposure,” Dugel said. “Based on this study, Alcon and Novartis have committed to further study of the higher dose of 6 mg of ESBA 1008.”
Disclosure: Dugel is a consultant for Alcon and Novartis.