FDA Clears Aviceda’s IND for Treatment of Geographic Atrophy from AMD

Aviceda Therapeutics announced that the FDA has granted clearance for the IND for AVD-104. This clearance will allow the company to proceed with the initiation of Phase 2 clinical trials of its leading intravitreal ocular asset for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The Phase 2 SIGLEC trial is anticipated to begin during the second quarter of 2023.

“The FDA’s acceptance of our IND application to initiate the clinical evaluation of AVD-104 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with geographic atrophy and macular degeneration,” said Mohamed Genead, M.D., Aviceda’s Co-Founder, President & Chief Executive Officer. “The AVD-104 IND clearance marks an important milestone for Aviceda as we continue our track record of execution as the leader in the glycome field. We are thrilled to advance the development of AVD-104 in the U.S. and are working to rapidly enroll patients in the Phase 2 portion of the study. We look forward to presenting additional data later this year.”

AVD-104 is a nanoparticle molecule that is administered intravitreally and possesses a distinctive dual mechanism of action aimed at treating GA. This mechanism involves the modulation of crucial inflammatory pathways by inhibiting the activity of retinal macrophages and repolarizing activated macrophages to their resolution state, as well as inhibiting complement cascade amplification.

“I am very excited to bring the power of our glyco-biology based technology platform to address the significant unmet medical needs in patients with macular degeneration. As a practicing vitreoretinal specialist, I saw firsthand the devastating effect of this disease on my patients. This is the first step in bringing a novel and differentiated therapy to these patients,” said David Callanan, M.D., Chief Medical Officer of Aviceda.