Good results seen in early-stage intravitreal gene therapy trial for wet AMD
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Key takeaways:
- Positive interim data were reported for intravitreal 4D-150 for the treatment of wet age-related macular degeneration.
- High-dose 3E10 vg per eye demonstrated the greatest level of activity at 24 weeks.
Intravitreal 4D-150 demonstrated positive interim results for the treatment of wet age-related macular degeneration in a phase 1/2 trial, according to a press release from 4D Molecular Therapeutics.
In the phase 1 dose-exploration stage of the phase 1/2 PRISM clinical trial, five patients received a dose of 3E10 vg per eye of the dual-transgene intravitreal gene therapy, five received 1E10 vg per eye and five received 6E9 vg per eye.
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The dose was well tolerated by all patients at 24 weeks, and 14 patients experienced no inflammation after treatment. There were no reports of serious adverse events or cases of hypotony or dose-limiting toxicities across the cohorts.
All three doses demonstrated clinical activity, with 3E10 vg per eye demonstrating the highest level of activity at 24 weeks, including a clinically meaningful improvement in mean central subfield thickness of –92 µm at 36 weeks and stable mean best corrected visual acuity. In addition, four of the five patients did not require a supplemental aflibercept injection.
The phase 2 dose-expansion stage of the trial, which will include 50 patients, is more than 50% enrolled, with completion expected later this year.
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