Ocular Locks In AXPAXLI NDA Path After FDA Type C

The Tip Desk · August 4, 2026 · 4 min read

The company plans a fourth-quarter 2026 wet AMD filing under 505(b)(2), with cash of $598.6 million and a net loss of $78.8 million.

Ocular Therapeutix (OCUL), an integrated biopharmaceutical company, said a May 2026 FDA Type C meeting formalized a path to file a new drug application for AXPAXLI in wet age-related macular degeneration in the fourth quarter of 2026.

The company will not host a second-quarter conference call after its June investor day and plans to resume earnings calls with third-quarter results.

Executive Chairman, President and CEO Pravin U. Dugel said the June investor day marked a pivotal milestone with an FDA-aligned path to NDA submission. The filing is to rest on SOL-1 Week 52 efficacy and safety data, an interim SOL-R safety analysis of patients who have reached Week 52, and confirmatory evidence, including axitinib’s profile as a VEGFR inhibitor from more than a decade of clinical use.

Ocular intends to use the Section 505(b)(2) pathway, which could shorten review by up to 60 days. A pre-NDA meeting is scheduled for the third quarter of 2026. The interim SOL-R safety readout, together with the existing SOL-1 safety database, is expected to bring the aggregate safety set to more than 300 patients with at least one year of AXPAXLI exposure.

SOL-1, the registrational superiority trial against a single injection of aflibercept (2 mg), had already reported positive Week 52 topline data in February 2026. In that trial, 74.1% of AXPAXLI-treated subjects maintained vision at Week 36, a 17.5% risk difference versus aflibercept, and 65.9% maintained vision at Week 52, a 21.1% risk difference.

A new post-hoc SOL-1 analysis applying SOL-R rescue criteria estimated up to a 72% reduction in injection burden over 60 weeks versus a projected on-label aflibercept (2 mg) every-eight-weeks schedule, excluding loading doses, and a 56% reduction including loading doses. The proportion of SOL-1 patients who would have remained rescue-free under those criteria was 66.5% at Week 52. Chief Development Officer Peter K. Kaiser said up to 40% of wet AMD patients discontinue therapy within the first year, largely because of treatment burden.

SOL-R was amended to maximize label potential after the FDA confirmed that SOL-R efficacy data are not required for the NDA. The trial now adds a key secondary endpoint of superiority to aflibercept (8 mg) at Week 96 and another evaluating prevention of fibrosis and atrophy versus aflibercept (2 mg) at Week 96. Efficacy analysis and sponsor masking will run to Week 96. Topline SOL-R results are now expected in the first quarter of 2028, later than the first-quarter 2027 timing cited in the prior quarter. The primary endpoint of non-inferiority to aflibercept (2 mg) at Week 56 is unchanged.

The three-year open-label SOL-X extension, dosing AXPAXLI every 24 weeks, enrolled its first subject in April 2026. The diabetic retinopathy program was streamlined to prioritize HELIOS-3 as a potential single registrational trial in non-proliferative diabetic retinopathy, now evaluating AXPAXLI every 12 months versus sham in 620 patients, down from 930. The amendment reflected observed durability of up to 12 months in SOL-1, HELIOS-1 data, and market research on physician preference for once-yearly dosing.

Commercial readiness is advancing ahead of a potential 2027 launch. Market research after SOL-1 found about 80% of retina specialists surveyed would likely use a product with AXPAXLI’s profile, with more than 90% expected to adopt it within its first year if approved. The payer team has engaged 100% of Tier 1 Medicare Advantage and commercial payers, who indicated a label demonstrating superior durability could command premium pricing.

Total net revenue was $13.5 million in the second quarter ended June 30, 2026, flat versus the year-earlier quarter. Gross DEXTENZA product revenue, net of discounts, rebates, and returns, increased $0.1 million, or 0.6%. Collaboration revenue was $0.0 million versus $0.1 million a year earlier.

Research and development expenses were $54.1 million, up from $51.1 million, due to higher clinical costs across SOL-1, SOL-R, SOL-X, and HELIOS-3 and preparations for the planned NDA. Selling and marketing expenses were $17.3 million, versus $13.7 million, on commercial-team expansion and pre-commercial investment. General and administrative expenses were $22.2 million, versus $14.3 million.

Net loss was $78.8 million, or $0.35 a share, compared with a net loss of $67.8 million, or $0.39 a share, a year earlier. Cash and cash equivalents were $598.6 million as of June 30, 2026, down from $666.7 million as of March 31. That balance is sufficient to support planned operating expenses, debt service, and capital expenditures into 2028, including SOL-1 completion, SOL-R, SOL-X and HELIOS-3, and pre-commercial work, but not the full near-term commercialization costs of AXPAXLI if approved. Outstanding shares were about 225.0 million as of July 31, 2026.