- Graybug Vision (GRAY -7.2%) has reported the results from full-data analysis of the Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD).
- Conducted across 33 sites in the U.S., the masked and controlled trial was designed to evaluate two doses of GB-102 with a single control arm of patients on aflibercept.
- The primary endpoint is the median time taken to the first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor.
- The mean change of best-corrected visual acuity (BCVA) and mean change of central subfield thickness (CST) of the retina were secondary endpoints which however were not powered to show the higher efficacy of GB-102 against aflibercept.
- During the 12-month treatment phase, GB-102 1mg was safe and well-tolerated, the company said adding that most treatment-related adverse events were mild to moderate.
- Compared with baseline, the control of CST in patients receiving twice-a-year GB-102 1mg was similar to bi-monthly aflibercept. BCVA has also trended lower in GB-102 1mg patients compared to aflibercept.
- The company is looking for a partner to further advance the experimental therapy and in the process of designing an additional trial to evaluate an enhanced formulation of GB-102 in wet AMD, CEO Fred Guerard said.
- “We will pause development of GB-103 and GB-102 for diabetic macular edema while we devote our current cash to advancing GB-401 through Phase 1 clinical development,” Guerard added.
- Results from the ongoing six-month extension period of ALTISSIMO are expected in Q4 2021.
- In March, Graybug Vision reported topline data from the 12-month treatment phase of the trial.