OCUL Stock Is Climbing Ahead Of Investor Day — What Is On The Agenda?

• The company said the NDA will be supported by safety and efficacy data from the Phase 3 SOL-1 trial, along with interim safety data from the ongoing SOL-R study.
• Ocular’s new secondary endpoint will evaluate whether Axpaxli can outperform Aflibercept, another wet AMD therapy.
• Ocular plans to streamline its development program for non-proliferative diabetic retinopathy by focusing on a single Phase 3 study.

Shares of Ocular Therapeutix Inc. (OCUL) climbed 5% on Wednesday after the company outlined a regulatory path for its experimental wet age-related macular degeneration (AMD) therapy, ahead of its Investor Day presentation.

Ocular said its U.S. Food and Drug Administration (FDA)- aligned New Drug Application (NDA) for Axpaxli is expected to be submitted in the fourth quarter of 2026, with details to be shared during the presentation later in the day.

OCUL To Conduct Interim Safety Analysis

The company said the NDA will be supported by safety and efficacy data from the Phase 3 SOL-1 trial, along with interim safety data from the ongoing SOL-R study. Ocular plans to conduct an interim SOL-R safety analysis in late 2026, allowing it to exceed the FDA’s requirement of at least 300 patients with one year of safety exposure across studies.

However, the efficacy results from SOL-R will not be included in the NDA package. Instead, the trial will remain blinded through Week 96, with topline results now expected in the first quarter (Q1) of 2028. Ocular has added a new secondary endpoint that will evaluate whether Axpaxli can outperform Aflibercept, another wet AMD therapy, at Week 96.

The company expects to submit the application through the FDA’s 505(b)(2) pathway, which could shorten the review timeline by up to 60 days. A pre-NDA meeting is planned for the third quarter (Q3) of 2026, ahead of the targeted filing later in the year.

OCUL To Streamline Diabetic Retinopathy Study

Ocular also plans to streamline its development program for non-proliferative diabetic retinopathy by focusing on a single Phase 3 study, HELIOS-3.

“Expanding on our confidence in Axpaxli and based on the demonstration of up to 12 months of durability seen in SOL-1 and HELIOS-1, we have also made the strategic decision to streamline our diabetic retinopathy program to prioritize a single global registrational trial, HELIOS-3, evaluating Q12M AXPAXLI versus sham,” said Pravin U. Dugel, President and CEO of Ocular Therapeutix.

What Is Retail’s Take On OCUL?

Retail sentiment surrounding OCUL on Stocktwits shifted to ‘bullish’ from ‘bearish’ over the past 24 hours, accompanied by ‘extremely high’ message volumes.

One user expects the FDA to approve the NDA and the stock to climb more than 100% from the current levels.

Another user said the latest update opens up the door for buyout bids.

The stock has been under selling pressure so far this year, declining more than 26%.

Read also: All Eyes On Capricor Therapeutics Ahead Of Crucial Hearing On DMD Therapy Agreement – CAPR Stock Jumps 6%

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