Enrollment complete in Graybug’s phase 2b wet AMD treatment trial

The final patient has been enrolled in a phase 2b trial of Graybug Vision’s wet age-related macular degeneration treatment candidate, according to a press release.

The multicenter, prospective, masked, randomized ALTISSIMO trial is comparing 1 mg and 2 mg dosing regimens of GB-102, a microparticle depot formulation of the anti-VEGF sunitinib malate, administered every 6 months and aflibercept administered every 2 months.

A limited interim safety analysis of the trial, which began in September 2019, supports the company’s plan to take the 1 mg dose forward, the release said. This plan of action is expected to accelerate the final data analysis by approximately 6 months.

“We are confident that with over 40 patients receiving 1 mg of GB-102 through the 12-month endpoint, the ALTISSIMO trial will have a sufficiently large sample size to inform the design for our phase 3 program of GB-102 in wet AMD, while preserving the trial’s scientific integrity since the dosing regimen will remain masked. We expect the ALTISSIMO trial read-out to occur approximately 6 months earlier than originally planned,” Frederic Guerard, CEO of Graybug Vision, said in the release.

The final patient has been enrolled in a phase 2b trial of Graybug Vision’s wet age-related macular degeneration treatment candidate, according to a press release.

The multicenter, prospective, masked, randomized ALTISSIMO trial is comparing 1 mg and 2 mg dosing regimens of GB-102, a microparticle depot formulation of the anti-VEGF sunitinib malate, administered every 6 months and aflibercept administered every 2 months.

A limited interim safety analysis of the trial, which began in September 2019, supports the company’s plan to take the 1 mg dose forward, the release said. This plan of action is expected to accelerate the final data analysis by approximately 6 months.

“We are confident that with over 40 patients receiving 1 mg of GB-102 through the 12-month endpoint, the ALTISSIMO trial will have a sufficiently large sample size to inform the design for our phase 3 program of GB-102 in wet AMD, while preserving the trial’s scientific integrity since the dosing regimen will remain masked. We expect the ALTISSIMO trial read-out to occur approximately 6 months earlier than originally planned,” Frederic Guerard, CEO of Graybug Vision, said in the release.