Ocular plans Q4 AXPAXLI filing after FDA meeting
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- Ocular Therapeutix reported flat Q2 revenue of $13.5 million and a net loss of $78.8 million.
- Ocular shares were down 3.71% at $8.17 in premarket trading following the results.
- Ocular plans to submit its AXPAXLI application in Q4 2026 after reaching alignment with the FDA.
Ocular Therapeutix (NASDAQ:OCUL) reported Q2 revenue of $13.5 million and plans a Q4 AXPAXLI filing after FDA alignment.
Revenue was flat year over year, while the net loss widened to $78.8 million from $67.8 million.
The filing will combine SOL-1 data with interim SOL-R safety results covering more than 300 patients with one-year exposure.
Following the announcement, Ocular Therapeutix's share price was down 3.71% at $8.17 in premarket trading.
Ocular held $598.6 million in cash, which the company expects will fund its planned operations into 2028.
A post-hoc SOL-1 analysis estimated up to 72% lower treatment burden versus projected on-label aflibercept over 60 weeks.
