FDA agrees to design of phase 2b/3 intermediate dry AMD clinical trial
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Key takeaways:
- Allegro received agreement from the FDA under a special protocol assessment for the design of a phase 2b/3 clinical trial.
- The trial will investigate risuteganib for dry age-related macular degeneration.
The FDA granted agreement under a special protocol assessment for the design of a clinical trial investigating risuteganib for the treatment of intermediate dry age-related macular degeneration, according to Allegro Ophthalmics.
The decision means that the FDA agrees with the overall protocol design of the upcoming phase 2b/3 trial and that its critical elements “are adequate and acceptable for a study intended to support a future marketing application,” a press release said.
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Study participants will receive five intravitreal injections of Luminate (risuteganib) 12 weeks apart, with treatment continuing through the follow-up safety period. Efficacy will be evaluated at 52 weeks and safety through 96 weeks. Best corrected visual acuity improvement at 52 weeks will be the primary endpoint in the risuteganib group vs. the sham control group.
Allegro based the design of the phase 2b/3 trial on a previous phase 2a study in which 48% of participants treated with risuteganib at week 28 and 7% of participants who received sham at week 12 met the study’s primary endpoint with a gain of eight letters of vision or more from baseline (P = .013).
“The agreement by the FDA of the SPA provides a clear regulatory path for our first-in-class drug, risuteganib, for the treatment of intermediate dry AMD for an unmet medical need,” Vicken Karageozian, MD, president and CEO of Allegro, said in the release.
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