Ocular Therapeutix Q1 Earnings Call Highlights

Key Points

• AXPAXLI’s Phase 3 SOL-1 trial showed statistical superiority to aflibercept (p=0.0006) and durable disease control, with about two‑thirds of patients maintaining vision for a year after a single injection and a substantially delayed need for rescue treatment versus aflibercept.
• NDA planning is underway based on SOL-1 week‑52 data using a 505(b)(2) pathway, while SOL‑R (631 randomized, non‑inferiority) remains on track with top‑line data now expected in Q1 2027 and SOL‑X (long‑term extension) has begun enrollment.
• Ocular is accelerating commercial readiness—positioning AXPAXLI as a possible six‑month fixed‑dosing option—and ended Q1 with approximately $667 million in cash, which management says should fund the company into 2028 (excluding full commercialization expenses).

Ocular Therapeutix NASDAQ: OCUL management used its first-quarter 2026 earnings call to highlight clinical and regulatory progress for AXPAXLI, the company’s investigational therapy for wet age-related macular degeneration (wet AMD), while also outlining next steps for its broader retinal disease pipeline and commercialization planning.

SOL-1 data positioned as a turning point in wet AMD

Executive Chairman, President, and CEO Dr. Pravin Dugel said the company believes the Phase 3 SOL-1 trial “fundamentally changed the conversation in wet AMD,” emphasizing that AXPAXLI was “the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a phase III wet AMD trial.” Dugel highlighted statistical strength for the primary endpoint, citing a p-value of 0.0006.

Dugel said the company sees the clinical significance as equally important, pointing to what he described as durability and disease control with fewer rescue treatments. He said that “in two-thirds of the patients, just a single AXPAXLI injection maintained vision for an entire year.” He also described a meaningfully delayed time to first rescue versus aflibercept, stating that the rescue rate in the aflibercept arm at week 28 “was not reached in the AXPAXLI arm until six months later at week 52.”

In discussing additional analyses presented at The Macula Society and the Vit-Buckle Society annual meeting, Dugel cited data on time to fluid volume increases. He said subjects treated with AXPAXLI took “about 5–6 months longer” to reach certain fluid thresholds compared with aflibercept, which he framed as a marker of sustained anatomic disease control.

Safety and transparency emphasized

Dugel said AXPAXLI was well-tolerated in SOL-1 and that the company has been “extremely transparent” regarding safety. He told investors the company provided subject-level details in medical meeting presentations and reported that it did not observe “a single treatment-related serious ocular or systemic adverse event such as endophthalmitis or vasculitis.”

Regulatory path and trials: NDA planning, SOL-R timing, and SOL-X launch

Management said it remains on track to submit a New Drug Application based on SOL-1 week 52 data, “subject to ongoing formal discussions with the U.S. FDA.” Dugel noted that the FDA has publicly discussed moving toward a single registrational trial as a default option for approvals and said Ocular believes SOL-1 “checks all the boxes,” including having a Special Protocol Assessment (SPA). He added that the company intends to use the 505(b)(2) pathway and said it may allow for a shortened review timeline.

During Q&A, analysts repeatedly asked for more detail on the timing and content of FDA interactions, including whether a pre-NDA meeting had occurred. Dugel said the company is “not in the habit of disclosing the details of our FDA meetings,” but described the discussions as “ongoing,” “formal,” and “collaborative.” When asked about scenarios where the company might file with SOL-1 versus waiting for SOL-R, he said Ocular had not disclosed timelines and would update investors “when appropriate.”

For SOL-R, Dugel said Ocular completed randomization of 631 subjects in December 2025, exceeding the original 555-subject target. Due to swift enrollment, the company accelerated guidance for SOL-R top-line data to the first quarter of 2027. Dugel described SOL-R as a non-inferiority trial designed to complement SOL-1 and said the study includes a 24-week screening and loading phase before randomization intended to screen out high fluid fluctuations. He said retention is strong and site engagement remains high.

Ocular also announced initiation of enrollment in SOL-X, an open-label long-term extension study in wet AMD. Dugel said SOL-X will follow subjects who have completed two-year follow-up in SOL-1 or SOL-R for an additional three years, for total follow-up of five years. He said the crossover design—where subjects initially treated with aflibercept transition to AXPAXLI—could help evaluate whether delaying AXPAXLI affects long-term outcomes such as fibrosis and atrophy, which he associated with “pulsatile VEGF suppression.”

Commercial readiness and expected use in practice

Dugel said the company is accelerating commercial readiness “in parallel,” including building infrastructure, engaging payers, and refining its commercial strategy. Chief Operating Officer Donald Notman, Chief Strategy Officer Sanjay Nayak, and Chief Commercial Officer Steve Meyers joined Dugel for the Q&A portion, though Dugel answered the questions in the transcript provided.

Asked about how retina specialists might integrate AXPAXLI based on SOL-1, Dugel said discussions are ongoing and offered his view that AXPAXLI could become an “every six months, fixed dosing drug.” He said some physicians might move directly to fixed dosing while others could start with a treat-and-extend approach before transitioning as confidence builds. Dugel also argued that adoption could be seamless because “nothing changes for the doctor,” pointing to a self-sealing 25-gauge needle and no new equipment requirements.

HELIOS-3 in diabetic retinopathy and upcoming Investor Day

Beyond wet AMD, Dugel said the HELIOS-3 trial in diabetic retinopathy remains ongoing and described it as a superiority study intended to support a broad label across diabetic retinal disease. He said HELIOS-3 allows enrollment of patients with non-central involved diabetic macular edema (DME), reflecting a continuum of disease. In response to a question about enrollment proportions for non-central involved DME, Dugel said there was no such requirement that the company had guided to. He added that Ocular believes it will not need another diabetic retinopathy study to cover diabetic retinal disease broadly, while also noting it is “far too early” for FDA labeling discussions.

Ocular announced it will host an Investor Day on June 17 in New York City. Dugel said the company plans to provide regulatory updates regarding the NDA submission plan in wet AMD, detailed updates on SOL-R and SOL-X, diabetic retinopathy program updates, and “a first look” at its planned commercialization strategy for AXPAXLI. He said the event will also feature retinal key opinion leaders discussing SOL-1, expectations for SOL-R, and the evolving wet AMD treatment landscape.

On the financial front, Dugel said Ocular ended the first quarter with approximately $667 million in cash, which management expects will provide runway into 2028. He added that the runway estimate does not include the full expenses anticipated to support commercialization of AXPAXLI.

About Ocular Therapeutix NASDAQ: OCUL

Ocular Therapeutix, Inc is a biopharmaceutical company dedicated to the development of innovative therapies for diseases and conditions of the eye. Founded in 2011 and headquartered in Bedford, Massachusetts, the company focuses on sustained-release drug delivery platforms designed to address key unmet needs in ophthalmology. Its proprietary hydrogel-based inserts and sealants aim to improve patient compliance and outcomes by providing controlled release of active pharmaceutical ingredients directly to ocular tissues.

The company's flagship product, DEXTENZA®, is a preservative-free, sustained-release dexamethasone intracanalicular insert approved by the U.S.

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