Search This Blog

Tuesday, March 9, 2021

Graybug Vision trial results disappoint

 Graybug Vision Inc (NASDAQ: GRAY) shares are dropping after preliminary data from Phase 2b ALTISSIMO trial of GB-102 for wet age-related macular degeneration (wet AMD).

  • Investors are reacting to the mean change of best-corrected visual acuity (BCVA) from the baseline that was lower in GB-102 1mg than aflibercept arm.

  • The mean change from baseline for BCVA for all 20 completers was approximately nine letters lower across all time points versus the study control arm.

  • The study was designed to evaluate two separate doses of GB-102, 1mg, and 2mg, injected every six months compared with Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Eylea (aflibercept) injected every two months.

  • After interim safety analysis, the 2mg dose was discontinued after the initial dose, and all patients were switched to 1mg for their second dose.

  • The median time to first supportive therapy was five months for GB-102 1mg (primary endpoint of the study).

  • Central subfield thickness of the retina in the GB-102 1mg arm was consistent with the study control arm.

  • GB-102, the company's lead product candidate, is a microparticle depot formulation of sunitinib malate, injected intravitreally.

  • Sunitinib is marketed as Sutent by Pfizer Inc (NYSE: PFE).

  • Piper Sandler has downgraded GRAY to Neutral with a price target of $10 from $27 earlier.

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.