FDA agrees to amend special protocol assessment for trial of Axpaxli in wet AMD
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Key takeaways:
- The SOL trial will now include treatment-naïve patients with wet AMD and visual acuity of 20/80 or better at screening.
- The amendment, which expands eligibility criteria, is expected to accelerate enrollment.
The FDA has agreed to a special protocol assessment agreement modification for Ocular Therapeutix’s phase 3 SOL clinical trial of Axpaxli, an axitinib intravitreal implant for treatment of wet age-related macular degeneration.
According to a company press release, the special protocol assessment (SPA) amendment expands the trial’s eligibility criteria to include treatment-naïve individuals with wet AMD and visual acuity of at least 20/80. To qualify for enrollment, participants would need to gain at least 10 ETDRS letters from the initial screening visit to day 1 or achieve a visual acuity of approximately 20/20 or better at day 1, after two aflibercept injections during screening.
“With the changes reflected in the SPA agreement modification agreed to by the FDA, we believe we can accelerate the enrollment process for the SOL trial,” Antony Mattessich, CEO of Ocular Therapeutix, said in the release.
In addition, the SPA agreement modification will allow the trial to evaluate Axpaxli with a single implant and drug load of 450 g of a more soluble form of axitinib, which is expected to provide a slightly increased daily release of the drug, the company stated.
“We have worked closely with the FDA to ensure that the SOL trial meets the agency’s updated guidance for wet AMD clinical trials, and we are eager to advance our engagement with clinical sites to enroll this trial under these new criteria,” Mattessich said in the release.
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