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Aerie Pharma Reports Mixed Bag On Phase 2 Dry Eye Trial

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Aerie Pharma Reports Mixed Bag On Phase 2 Dry Eye Trial
  • Aerie Pharmaceuticals Inc (NASDAQ: AERIannounced topline results of its Phase 2b COMET-1 study evaluating AR-15512 (TRPM8 Agonist) ophthalmic solution for dry eye disease.
  • The company said that the study failed to achieve statistical significance at pre-determined primary endpoints at Day 28.
  • However, the ophthalmic solution reached statistical significance over multiple pre-specified symptoms and signs, Aerie added.
  • Aerie observed the most significant efficacy in the higher concentration, and the company has decided to advance AR-15512 (0.003%) BID for a Phase 3 study.
  • “While we did not achieve statistical significance at our pre-determined primary endpoints at Day 28, as a reminder, this is a Phase 2b study where selecting primary endpoints are not required. Therefore, we believe we have a clear path toward approval,” CEO Vicente Anido remarked.
  • Both formulations at 0.0014% and 0.003% were safe and well-tolerated.
  • 95% of adverse events were mild, 3% of subjects in the 369-patient study have discontinued the trial due to adverse events.
  • Related content: Benzinga's Full FDA Calendar.
  • The company plans to have an end of Phase 2 meeting with the FDA in Q1 of 2022.
  • It also plans to conduct two additional three-month Phase 3 efficacy studies and an additional safety study to complete the development of AR-15512.
  • Price Action: AERI shares closed 0.57% lower at $15.70 on Wednesday.
 

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Posted-In: Briefs dry eye diseaseBiotech News Health Care Small Cap FDA General

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