Per May 2026 Type C meeting, AXPAXLI NDA for wet AMD to be based on SOL-1 Week 52 efficacy and safety plus interim SOL-R safety data

Ocular to conduct interim SOL-R safety analysis in 4Q 2026 to reach >300 patients of safety data across SOL-1 and SOL-R, in alignment with FDA requirements

Complete AXPAXLI NDA package in wet AMD planned to be submitted in 4Q 2026

SOL-R efficacy data no longer part of the AXPAXLI NDA submission plan

Ocular will evaluate superiority of AXPAXLI vs aflibercept (8mg) Q6M at Week 96 as a key secondary endpoint of the SOL-R trial

SOL-R to remain masked through Week 96, with topline results now expected in 1Q 2028

New secondary endpoint addition to SOL-R has the potential to establish AXPAXLI as a best-in-disease agent for wet AMD and further differentiate potential label to support broad global adoption, if approved

In alignment with the FDA, Ocular plans to submit its NDA under the 505(b)(2) pathway, with potential to accelerate the review timeline by up to 60 days

Following strong SOL-1 data, diabetic retinopathy program also streamlined to prioritize HELIOS-3 as a potential single registrational trial evaluating Q12M dosing of AXPAXLI

The event will begin at 2:00 PM ET today in New York City with virtual access available



 

BEDFORD, Mass., June 17, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular"))), an integrated biopharmaceutical company committed to redefining the retina experience, will host an Investor Day today to showcase its FDA-aligned plans to submit its NDA for AXPAXLI™ (also known as OTX-TKI) in wet AMD in the fourth quarter of 2026 based on SOL-1 efficacy and safety data together with interim SOL-R safety data. With SOL-R efficacy data no longer part of the planned AXPAXLI NDA submission, Ocular is amending the design of SOL-R and plans to extend masking to evaluate new secondary endpoints at Week 96 to show potential superiority in best corrected visual acuity (BCVA) over aflibercept (8 mg) and to support further differentiation from aflibercept (2 mg) in the potential label for AXPAXLI. Topline data for SOL-R are now expected during the first quarter of 2028. Ocular also plans to streamline its registrational program in non-proliferative diabetic retinopathy (NPDR) to prioritize a single Phase 3 trial, HELIOS-3.