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Preclinical studies show pSivida's Durasert implant delivering TKI just as effective as injection of FDA-approved biologic in wet AMD; shares up 5%

  • Thinly traded micro cap pSivida (PSDV +5.4%) bucks the market's bearishness. Shares are up on average volume (only ~23K shares so far) in response to its announcement of positive results from preclinical animal studies assessing the effectiveness of a sustained-release insert based on its Durasert technology to deliver a tyrosine kinase inhibitor (TKI) for the treatment of wet age-related macular degeneration (wet AMD).
  • The data showed the TKI insert was similar in efficacy to an injection of an FDA-approved AMD biologic in preventing choroidal neovascularization (formation of new blood vessels) and reducing vascular leakage.
  • Based on the encouraging results, the company intends to advance the Durasert TKI insert into clinical development.
  • TKIs are currently used to treat cancer, but some inhibit a growth factor called PDGF (platelet-derived growth factor) which plays a key role in blood vessel formation. The TKI used by pSivida inhibits both PDGF and VEGF (vascular endothelial growth factor). AMD meds Lucentis (ranibizumab) and Eylea (aflibercept) are both VEGF inhibitors. In cancer, TKIs are taken orally because systemic administration is too toxic. PSivida's approach aims to deliver a TKI dose directly to the retina that is 1,000 times less that the dose used to treat cancer.
  • Related tickers: (OTCQX:RHHBY -1.5%)(REGN -0.5%)

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