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Cloudbreak Pharma has reported topline results from its multi-regional, double-masked, randomized, vehicle-controlled P-III (CS-301) study of CBT-001 ophthalmic emulsion in pts with pterygium (n=659)
Both CBT-001 0.1% & 0.2% BID met the 1EPs, showing statistically significant improvement in conjunctival hyperemia at Month 3 vs vehicle (p<0.001; benefit from Week 2 through Month 12) & prevention of pterygium lesion-length progression at Month 12 vs vehicle (p<0.001)
Superficial punctate keratitis was the most common AE (20% with 0.1% vs 8% vehicle), mostly resolving with artificial tears; Cloudbreak intends to meet the US FDA to discuss next steps for this potential first disease-modifying pterygium therapy
Ref: GlobeNewswire | Image: Cloudbreak Pharma | Press Release
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The post Cloudbreak Reports P-III (CS-301) Topline Data of CBT-001 for Pterygium appeared first on PharmaShots.
Cloudbreak Reports P-III (CS-301) Topline Data of CBT-001 for Pterygium | PharmaVoice