AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

After discussions with the US FDA, the company determined it can file AMX0035 based on Phase II/III results and interim Phase III data. Amylyx is sticking with its go-it-alone strategy for global commercialization.

Private Company Edition: Recent biopharma venture capital financings add up to $1.7bn, including a $135m crossover round for HilleVax after spinning out of Takeda in July to advance a norovirus vaccine, Skyhawk’s $133m in fresh funding and Obsidian’s $115m series B round.

ProQR’s Axiomer platform can enable single nucleotide RNA editing, an approach that could address thousands of disease-causing genetic mutations, the company says.