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Graybug Vision Inc (NASDAQ: GRAY) has provided full-data analysis from the 12-month treatment Phase of its Phase 2b ALTISSIMO trial evaluating GB-102 to treat wet age-related macular degeneration (wet AMD).
GB-102 is a proprietary formulation of sunitinib malate injected twice a year intravitreally.
The ALTISSIMO full-data analysis focused on the GB-102 1mg arm compared to aflibercept and the pre-enrollment period, excluding results from the GB-102 2mg arm.
Overall, GB-102 1mg was safe and well-tolerated. No drug-related serious adverse events or vision-threatening inflammation were reported.
The majority of drug-related adverse events were mild to moderate. The particle migration to the anterior chamber in patients treated with GB-102 1mg was reduced by 79% compared to GB-102 1mg patients in the ADAGIO Phase 1/2a trial (4/51 injections vs. 3/8), and no surgical interventions were required.
As previously reported, patients in the GB-102 1mg trial arm (n=21) had a median time to first supportive therapy of five months, and 48% of patients did not require supportive treatment for at least six months.
An additional analysis showed the injection frequency was reduced by 58% compared to patients' treatment before enrollment in the trial.
The company is also working on a GB-401 implant program for glaucoma that will enter a Phase 1 trial in the first half of 2022.
Graybug expects to report the results from the ongoing six-month extension period of ALTISSIMO by the end of this year.
The company also said it would pause developing GB-103 and GB-102 for diabetic macular edema and utilize the cash to advancing GB-401 through Phase 1 clinical development.
The company's management will host a webcast and conference call at 8 a.m. ET today to discuss the ALTISSIMO clinical results.
Price Action: GRAY shares are trading 7.4% lower at $4.38 on the last check Wednesday.
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