Successful Phase 3 study results for Ocular's Axpaxli wet AMD drug

Successful Phase 3 study results for Ocular's Axpaxli wet AMD drug

Ocular Therpeutix announced successful results of their experimental drug Axpaxli in treating wet age-related macular degeneration.

 

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Ocular Therpeutix announced successful results of their experimental drug Axpaxli in treating wet age-related macular degeneration.

The Phase 3 study involved 344 patients with wet age-related macular degeneration (AMD). The study compared Axpaxli to Regeneron's Eylea. Eylea is a VEGF inhibitor while Axpaxli is a different drug known as a tyrosine kinase inhibitor.

The study participants had an initial 8 week period where they all received two injections of 2 mg of Eylea. After that time, participants were randomly assigned to either receive Axpaxli or Eylea and then monitored for another 36 weeks. 

After the 36 week period, 74% of Axpaxli recipients lost fewer than 15 letters on a visual acuity chart from baseline compared to 55.8% of the Eylea recipients who hit that parameter.

Ocular Therapeutix will now meet with the FDA to set a regulatory path for Axpaxli and file for an approval application after that.