Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.

Kala Pharmaceuticals is hoping to shake up the dry eye market with a NDA filing this year for its steroid eye drop KPI-121 0.25%.

Market Snapshot: Kala's Phase III nanoparticle along with Aldeyra's aldehyde trap drug and Ocugen's brimonidine/steroid combo, both in Phase II, are among the candidates pursuing Restasis and Xiidra.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.