BEDFORD, Mass., June 17 — Ocular Therapeutix, Inc. is set to host an Investor Day today to showcase its FDA-aligned plans to submit its New Drug Application (NDA) for AXPAXLI in wet AMD in the fourth quarter of 2026. The company’s plans are based on SOL-1 efficacy and safety data, which will be combined with interim SOL-R safety data. This approach is in alignment with the FDA requirements, and the complete AXPAXLI NDA package is expected to be submitted in the fourth quarter of 2026.
Strategically, the calculus behind this move signals a significant step forward for Ocular Therapeutix, as it seeks to establish AXPAXLI as a best-in-disease agent for wet AMD. A key aspect of the SOL-R trial is the evaluation of the superiority of AXPAXLI vs aflibercept at Week 96, which has been added as a new secondary endpoint.
This has the potential to further differentiate the potential label for AXPAXLI and support broad global adoption, if approved. The SOL-R trial will remain masked through Week 96, with topline results expected in the first quarter of 2028. The company’s decision to submit its NDA under the 505(b)(2) pathway is also noteworthy, as it has the potential to accelerate the review timeline by up to 60 days.
This move is in alignment with the FDA, and it signals a sense of urgency and momentum behind the development of AXPAXLI. What this signals is a commitment to bringing this treatment to market as quickly as possible, while also ensuring that it meets the rigorous standards of the FDA.
Following strong SOL-1 data, the diabetic retinopathy program has also been streamlined to prioritize the HELIOS-3 trial as a potential single registrational trial evaluating Q12M dosing of AXPAXLI. This move is a testament to the company’s focus on delivering innovative treatments that address significant unmet medical needs. The broader stakes are clear: the success of AXPAXLI has the potential to redefine the treatment landscape for wet AMD and diabetic retinopathy, and Ocular Therapeutix is strategically positioning itself to capitalize on this opportunity.
As the company hosts its Investor Day today, all eyes will be on the progress of AXPAXLI and the potential for this treatment to make a meaningful difference in the lives of patients. With its FDA-aligned plans and accelerated development timeline, Ocular Therapeutix is poised to make a significant impact in the field of ophthalmology. The event will begin at 2:00 PM ET today in New York City, with virtual access available. Consult your doctor for medical advice.
