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

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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%

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