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.
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Public Company Edition: Benefitting from hope that biopharma interventions will help the coronavirus pandemic, the industry is faring better than others in the stock market, including the ability to launch IPOs. Also, BridgeBio leads recent financings and PDL is on track to dissolve by year-end.
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.
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%.