First patients screened in clinical trial of Axpaxli for wet AMD
Click Here to Manage Email Alerts
Ocular Therapeutix announced that the first three participants have received an aflibercept injection in the phase 3 SOL-1 clinical trial of Axpaxli, an axitinib intravitreal implant for wet age-related macular degeneration.
“The screening of these subjects in the pivotal phase 3 SOL-1 trial of Axpaxli marks an exciting milestone for Ocular Therapeutix,” CEO Antony Mattessich said in a company press release. “Axpaxli has demonstrated promising durability, biological activity and a favorable safety profile in earlier studies. We believe that Axpaxli could set a new standard in wet AMD therapy by significantly extending time between treatments.”
According to the release, Axpaxli is a bioresorbable, hydrogel implant that incorporates the small-molecule, tyrosine kinase inhibitor axitinib, which is being investigated for treatment of wet AMD and other retinal diseases.
In January, the company announced that the FDA agreed to a special protocol assessment modification of the trial, allowing inclusion of treatment-naïve patients with wet AMD and baseline visual acuity of at least 20/80 to accelerate enrollment.
“Wet AMD patients need options that provide sustained therapy while minimizing their need for frequent injections and office visits,” principal investigator Allen Hu, MD, a vitreoretinal surgeon at Cumberland Valley Retina Consultants, said in the release. “I am thrilled to be participating in research that could shift the existing treatment paradigm for patients with wet AMD.”
Perspective
Back to Top
A new and exciting treatment for wet AMD is currently being investigated in the phase 3 SOL-1 clinical trial of Axpaxli. Axpaxli, which has anti-angiogenic properties, has shown excellent durability and safety in past investigational studies. Historically, intravitreal injections have been outstanding at targeting neovascular activity in wet AMD; however, these injections are costly and pose a large treatment burden on our patients due to the frequency of injections (every 4 to 8 weeks). In addition, reported complications include endophthalmitis, ocular hemorrhage, lenticular changes and retinal detachment. Axpaxli offers a targeted sustained release of 6 months or longer. This molecule has exhibited minimal to no negative visual impacts and is preservative-free. Axpaxli could offer a new standard in the treatment of wet AMD by significantly extending treatment intervals.
Read more about
Click Here to Manage Email Alerts