The drug, marketed across the Atlantic as Xiidra, has already made significant inroads in the US dry eye market which has been dominated by Allergan's Restasis
Shire's bid to further boost its presence in the dry eye disease market has been boosted by the submission of lifitegrast in Europe.
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The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.
The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.
The dual agonist of the FP and EP3 receptors has shown efficacy in a Japanese Phase III trial and completed its US Phase II study, which aligns with the Japanese firm’s global expansion strategy for glaucoma products.
BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.
The company is planning to start a registrational program on its home turf in Australia and is planning to bring the therapy to the US as well.
Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
