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.
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