Ocular Therapeutix™ Reports First Quarter 2025 Results and Business Highlights

In This Article:

Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.

AXPAXLI™ SOL trials for wet AMD progressing rapidly following recent updates to accelerate and enhance the registrational program

Following positive FDA feedback for potential AXPAXLI NPDR registrational trial, Ocular is actively planning next steps in NPDR and DME

SOL-1 retention remains exceptional as trial is on track for 1Q 2026 topline data readout

SOL-R continues to have strong enrollment through streamlined, accelerated execution

Cash balance of $349.7M as of March 31, 2025, with expected runway through topline data for SOL-1 and SOL-R and into 2028

BEDFORD, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the first quarter ended March 31, 2025, and provided recent business highlights.

“We continue to advance the SOL registrational program for our product candidate AXPAXLI in wet AMD with urgency and precision. Our unwavering focus is on redefining the retina experience. Delivering a more sustainable therapy designed to drive better long-term outcomes is central to this effort. Earlier this year, we implemented strategic regulatory updates designed to accelerate the SOL program, enhancing capital and operational efficiencies. We believe these refinements could position AXPAXLI for an unprecedented 6 to 12-month dosing regimen on the label for the treatment of wet AMD and potentially enable an earlier NDA submission. These enhancements were made in alignment with FDA feedback and preserve the scientific integrity and robust powering of our two complementary registrational studies, SOL-1 and SOL-R,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “In addition to our momentum in wet AMD, we are thrilled with the positive written feedback received from the FDA on the design of a potential registrational trial for AXPAXLI in NPDR. These encouraging interactions represent a meaningful step forward as we plan our next steps in both NPDR and DME.”

“Backed by a world-class team, strong capital position, and disciplined execution, we believe we are in an outstanding position as we pursue our goal of becoming a leading retina company,” concluded Dr. Dugel.

Recent Achievements and Upcoming Milestones:

  • SOL-1 (Phase 3, wet AMD) retention remains exceptional and the vast majority of rescues, evaluated on a masked basis, continue to be per protocol. Topline data are on track for 1Q 2026. In March, the Company announced that the FDA accepted an amendment to the SOL-1 Special Protocol Assessment (SPA) agreement that includes re-dosing of all subjects at Weeks 52 and 76 with their respective initial treatment of AXPAXLI or aflibercept (2 mg). Subjects will remain masked and are then followed for safety until the end of year two. This optimized design enhances the potential to achieve label flexibility for dosing AXPAXLI every 6 to 12 months and should provide valuable insights into AXPAXLI’s long-term durability.

  • SOL-R (Phase 3, wet AMD) enrollment continues to be strong following the recent reduction in target randomization to approximately 555 subjects (previously 825). The strong SOL-1 subject retention observed to date and re-dosing amendment have enabled Ocular to reduce the size of the SOL-R non-inferiority study while continuing to meet the FDA requirements for long-term safety data. Streamlining the execution of SOL-R is expected to accelerate the trial readout and, if successful, the AXPAXLI wet AMD NDA submission timeline. SOL-R remains robustly powered at 90% with the non-inferiority margin of -4.5 ETDRS letter per FDA guidance.

  • Written feedback received from FDA on AXPAXLI registrational trial in non-proliferative diabetic retinopathy (NPDR). The FDA provided positive feedback to Ocular on a potential registrational trial design for AXPAXLI in NPDR. Following recent changes more broadly within the FDA, Ocular has not noticed any disruption in the cadence and nature of its dialogue with the Agency to date and continues to maintain productive interactions. The Company is actively planning next steps in the development of AXPAXLI for NPDR and diabetic macular edema (DME) and expects to provide further details at a later date.