Kala Needs Big STRIDE To Get Dry Eye Drug OK
Executive Summary
The US FDA has issued a complete response letter for KPI-121 but Kala hopes to resubmit the drug during the first half of next year backed by data from the ongoing STRIDE 3 study.
You may also be interested in...
12 Approvals To Look Out For In Q4
The end of the year should see a flurry of new products reaching the market to break new commercial ground or shake up their respective therapeutic areas. Here, Scrip takes a look at 12 of the more interesting approvals expected in the coming months, with the help of analysts at Biomedtracker.
Kala’s Third Phase III Trial Should Line Up Approval In Dry Eye
Data showing that endpoints were met for both signs and symptoms of dry eye disease should position Kala’s KRI-121 for US approval. The company hopes to differentiate with short-term flare treatment.
TopiVert Has High Hopes For Dry Eye Drug Despite Trial Fail
A mixed set of results from a Phase IIb/III trial of TOP1630 has not deterred the privately-held firm which maintains that the anti-inflammatory kinase inhibitor is a promising treatment.