Graybug Vision Reports Preliminary Topline Results from Phase 2b ALTISSIMO Trial

• Median time to first supportive therapy was 5 months for GB-102 1mg
  
• 48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 months
• Control of retinal thickness was consistent across all trial arms
• Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept arm
• No drug-related serious adverse events
• Clinical monitoring is ongoing to observe durability beyond 6 months

REDWOOD CITY, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided preliminary topline data from the 12-month treatment phase of its Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug’s proprietary microparticle depot formulation of sunitinib malate injected intravitreally.

The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States. The primary endpoint is median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints are pharmacodynamics measures of mean change of best-corrected visual acuity (BCVA) from baseline and mean change of central subfield thickness (CST) of the retina from baseline.

The trial was originally designed to evaluate two separate doses of GB-102, 1mg and 2mg, injected every 6 months as compared with aflibercept injected every 2 months. Based on the results of an interim safety analysis, the 2mg dose was discontinued after the initial dose, and all patients in that arm were switched to 1mg for their second dose.

Analysis of the ALTISSIMO 1mg arm shows the primary endpoint of median time to first supportive therapy was 5 months. Furthermore, 48% of patients did not require supportive therapy for at least 6 months, and 62% of patients for at least 4 months or more, at least once during the trial. Overall, the 1mg dose performed better than the 2mg dose.

Overall, GB-102 1mg was well-tolerated. There were no drug-related serious adverse events, and the majority of drug-related adverse events were mild to moderate. Medication was detected in the anterior chamber in less than 10% of GB-102 1mg injections, and no adverse event required surgical intervention. There was no vision-threatening inflammation observed, and there was no increase in intraocular pressure reported.