Glaukos (GKOS) on Wednesday announced positive topline results from its phase 3 confirmatory trial for Epioxa, a corneal cross-linking treatment for keratoconus, a rare corneal disorder.
The trial achieved its primary efficacy endpoint, showing a clinically significant and statistically meaningful improvement in maximum corneal curvature, or Kmax at 12 months.
Key findings reveal a Kmax treatment effect of -1.0 diopter, with 91.5% of treated patients completing the 12-month trial with no reported serious treatment-related adverse events, and no evidence of systemic effects or changes in corneal endothelial cell counts, the company said.
Results from this second phase 3 confirmatory trial, along with the first phase 3 trial, are expected to support Glaukos' planned new drug application submission by the end of 2024.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。