Aviceda submits investigational new drug application for geographic atrophy treatment
Key takeaways:
- Aviceda submitted an investigational new drug application and a fast track designation application to the FDA for AVD-104.
- Positive safety results may support the initiation of phase 2 human trials.
Aviceda Therapeutics submitted an investigational new drug application to the FDA for AVD-104 for the treatment of geographic atrophy secondary to age-related macular degeneration.
The submission is supported by positive safety data for multiple doses of AVD-104 (glycan-coated nanoparticle) across IND-enabling Good Laboratory Practice toxicity studies, including dose-range finding studies in non-human primates and rabbits, according to a press release. The company is aiming to initiate phase 2 human clinical trials of the intravitreal nanoparticle.
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Additionally, Aviceda submitted a fast track designation application to the FDA for AVD-104.
“With only one currently approved therapy for the treatment of GA, there is still a significant unmet medical need for patients with this condition,” Mohamed Genead, MD, co-founder, CEO and president of Aviceda, said in the release. “This IND application brings us a step closer to bringing a new and differentiated treatment option for disease modification of the key underlying pathobiology of AMD via the modulation of immune and complement dysfunction.”
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