Ocular Therapeutix Sets AXPAXLI Filing as Loss Widens
Cash fell to $598.6 million, while the company maintained its runway into 2028.
Ocular Therapeutix (OCUL), an eye-disease drug developer, posted a wider second-quarter loss as it set a fourth-quarter timetable for its AXPAXLI regulatory submission.
Net revenue was flat at $13.5 million. DEXTENZA product revenue edged up 0.6%, while collaboration revenue fell to zero from $0.1 million a year earlier.
The net loss widened to $78.8 million from $67.8 million. The loss narrowed to $0.35 a share from $0.39 a share because weighted-average shares increased to about 225.0 million from 172.6 million.
Operating expenses rose 18% to $95.6 million as Ocular continued clinical development and prepared for a potential 2027 AXPAXLI launch. Research-and-development expense increased to $54.1 million, while general-and-administrative expense climbed to $22.2 million.
Ocular plans to submit AXPAXLI under the 505(b)(2) pathway in the fourth quarter following a third-quarter pre-NDA meeting and an interim SOL-R safety analysis. That pathway could shorten the review by as much as 60 days, with the submission expected to include more than 300 patients who have at least one year of safety data.
The regulatory plan sharpened even as Ocular extended SOL-R efficacy analysis and masking through Week 96, pushing topline results to the first quarter of 2028 from the first quarter of 2027. The study's randomized population reached 640 patients, compared with 631 reported in February and an original target of 555.
A new post-hoc SOL-1 analysis estimated that AXPAXLI could reduce injection burden 72% excluding loading doses and 56% including them compared with projected on-label aflibercept 2 mg dosing over 60 weeks. Under SOL-R rescue criteria, 66.5% of SOL-1 patients would have remained rescue-free at Week 52.
Ocular also reduced planned enrollment in the HELIOS-3 diabetic-retinopathy study to 620 patients from 930 and changed AXPAXLI dosing to once every 12 months. Selling-and-marketing expense rose 26% to $17.3 million as the company built commercial capacity, leaving the planned filing as the next milestone while the pivotal efficacy readout moved further out.