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Ocular Therapeutix Says Axpaxli New Drug Application Submission to US FDA Planned for Q4

Ocular Therapeutix (OCUL) said Wednesday it plans to submit a new drug application to the US Food and Drug Administration in Q4 for Axpaxli to treat wet age-related macular degeneration.The company said that after a Type C meeting with the FDA in May, the new drug application will be based on week 52 efficacy from the SOL-1 trial and safety plus interim data from the SOL-R trial.Ocular said it will conduct an interim SOL-R safety data analysis in Q4 to reach over 300 patients of safety data across the SOL-1 and SOL-R trial in alignment with FDA requirements.The company also said that, in alignment with the agency, it plans to submit the new drug application under the 505(b)(2) pathway, which has the potential to quicken the review timeline by up to 60 days.Ocular shares were up about 6% in morning trading.Price: $9.23, Change: $+0.29, Percent Change: +3.24%

$OCUL

Wire41d ago

Ocular Therapeutix Advances FDA Talks on Single-Trial Filing for Eye Drug, RBC Says

Ocular Therapeutix (OCUL) is moving closer to a potential US Food and Drug Administration filing for axpaxli, its long-acting treatment for wet age-related macular degeneration, as regulators begin formal discussions on a single-trial approval path, RBC Capital Markets said Tuesday in a report.Management said talks with the FDA are now ongoing, raising the possibility of submitting an application based on the company's successful pivotal study, rather than waiting for a second trial that is due to read out in early 2027, RBC said.The company plans to provide additional regulatory and program updates at an investor day on June 17, RBC said.Ocular continues to target a potential 2027 launch for axpaxli under a single-trial filing strategy, and RBC reiterated its view that the drug has a "positive benefit/risk profile."RBC maintained its rating of outperform, speculative risk, on Ocular stock with a $30 price target.Price: $9.84, Change: $+0.13, Percent Change: +1.29%

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