Benzinga | Sep 28, 2021 10:19AM EDT

Graybug Vision Posts Six-Month Extension GB-102 Data Of Wet AMD Trial

* Graybug Vision Inc (NASDAQ:GRAY) has provided a full-data analysis from the 18-month Phase 2b ALTISSIMO trial of GB-102 for wet age-related macular degeneration (wet AMD).

* GB-102 is Graybug's proprietary formulation of sunitinib malate injected twice a year intravitreally.

* Related Link: Graybug Vision Reports Full Data Analysis After One Year Treatment Of GB-102 In Wet AMD

* The ALTISSIMO trial was a masked and controlled Phase 2b dose-ranging study of two doses of GB-102, 1mg, and 2mg, with a single control arm of patients on 2mg Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) aflibercept.

* As previously reported, the Company terminated the development of GB-102 2mg in 2020 following an interim safety analysis.

* The Extension Study showed that 55% of GB-102 1mg patients experienced a treatment duration of 12 months or longer while maintaining visual acuity and central retinal thickness.

* The Company says that this is the longest duration achieved with an intravitreal injection in a randomized, masked, controlled clinical trial in wet AMD.

* In addition, the injection burden was reduced by 73% on an annualized basis.

* GB-102 1mg continued to indicate a favorable safety profile and was well-tolerated.

* Graybug anticipates that its GB-401 implant program for glaucoma will enter a Phase 1 trial in 2H of 2022.

* Given the 12-month or longer duration observed with GB-102 in the ALTISSIMO 18-month trial, Graybug decided to stop the further development of GB-103, which was designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection.

* Price Action: GRAY stock is down 3.84% at $3.51 during the market session on the last check Tuesday.