Ocular Therapeutix™ Announces Additional Positive Week 52 Data from Landmark SOL-1 Phase 3 Trial of AXPAXLI™ in Wet AMD

New SOL-1 post-hoc analyses presented at VBS reinforce AXPAXLI’s unmatched durability in wet AMD with sustained disease control

AXPAXLI demonstrated robust CSFT control with a median time of 39 weeks and 46 weeks to ≥30 and ≥75 uM increases from Week 8

In all AXPAXLI subjects who had a vitreous floater AE, drug particles are no longer visible (mean time of 20 weeks)

Subjects treated with AXPAXLI generally maintained loading phase visual acuity gains up to Week 52 across quartile subgroups based on BCVA at screening

Company remains on track to submit NDA based on SOL-1 alone, subject to planned formal discussions with the U.S. FDA, consistent with recent FDA public commentary

BEDFORD, Ma., April 13, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced additional positive Week 52 data from the SOL-1 Phase 3 superiority trial of AXPAXLI (also known as OTX-TKI), its investigational product candidate for the treatment of wet age-related macular degeneration (wet AMD). The additional post-hoc analyses, presented at the 14th Annual Vit-Buckle Society (VBS) Meeting, reinforce the superior durability, strong sustained disease control, and generally well-tolerated safety seen with AXPAXLI in SOL-1.

“The new analyses of the SOL-1 Phase 3 data further strengthen our conviction in AXPAXLI’s potential to redefine retina treatment. A clear drug profile has emerged for AXPAXLI: a product candidate with durability that is unmatched in the wet AMD space while demonstrating excellent sustained disease control,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “Several analyses presented at VBS reinforce this profile. As retina specialists, anatomic control measured with OCT guides our treatment decisions. The time-to-CSFT increase analyses provide powerful additional evidence of AXPAXLI’s efficacy. After Week 8, it takes a median of 39 weeks to reach a clinically meaningful increase of ≥30 uM in CSFT, and even longer to reach ≥75 uM. This is simply an unprecedented level of sustained disease control and allows us to re-imagine the management of wet AMD for patients. These data continue to increase our confidence that AXPAXLI may be adopted broadly and immediately, if approved. Most importantly, we remain on track to submit our NDA based on SOL-1 alone, subject to planned formal U.S. FDA discussions. The FDA Commissioner recently noted that the Agency expects this new default framework for approval based on a single pivotal trial to be phased in over the next six months or so, aligning with our goal of bringing AXPAXLI to patients as soon as possible.”

Highlights from the data presented at VBS include:

• Strong overall efficacy profile with unmatched durability: Achieved statistical significance in the first three of five key secondary endpoints tested in hierarchical order. In addition, six other pre-specified secondary endpoints measuring clinically significant functional and anatomic outcomes were met with statistical significance.
• Sustained disease control (post-hoc analysis): Subjects in the AXPAXLI arm had significantly lower risk in anatomic worsening from Week 8 compared to the aflibercept (2 mg) arm. Week 8 was chosen to give both arms adequate time from the last aflibercept (2 mg) injection and start at a similar reference timepoint.
  • The median time to ≥30 uM Central Subfield Thickness (CSFT) increase from Week 8 was 39 weeks in the AXPAXLI group and 16 weeks in the aflibercept (2 mg) group, a 23-week difference. An estimated hazard ratio of 0.7 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 30% lower risk of the event (descriptive p=0.0028) compared with the control group.
  • The median time to ≥75 uM CSFT increase from Week 8 was 46 weeks in the AXPAXLI group and 24 weeks in the aflibercept (2 mg) group, a 22-week difference. An estimated hazard ratio of 0.5 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 50% lower risk of the event (descriptive p