Ocular Therapeutix Inc. (NASDAQ:OCUL) stock surged on Monday after the company announced plans to accelerate the timeline for submitting a New Drug Application (NDA) for Axpaxli (OTX-TKI) in the treatment of wet age-related macular degeneration (wet AMD).
The company intends to submit an NDA for Axpaxli following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial, for which data are on track for the first quarter of 2026.
William Blair noted, “Compared to prior expectations of filing after the results from SOL-R (reading out in the first half of 2027), this would expedite a submission and potential approval decision by over a year, and would likely make it the first long-acting TKI to market.”
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FDA Regulatory Context
The update follows recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA’s Division of Ophthalmology.
The FDA has historically required two adequate and well-controlled clinical trials to demonstrate the safety and efficacy of ophthalmic product candidates, particularly for larger indications of use such as wet AMD.
Recent statements from FDA leadership indicate that the Agency is potentially moving to requiring only a single registrational trial for approval, as long as the trial is adequately powered and controlled.
Based on Ocular’s SPA agreement for SOL-1, along with the trial’s superiority design, the company plans to work with the FDA to submit its NDA for Axpaxli in wet AMD following year one results from SOL-1.
Clinical Program And Data Readouts
The company expects that additional data from the continuation of SOL-1 in year two, SOL-R, and SOL-X will help clinicians and payors appreciate the anticipated benefits of Axpaxli’s efficacy, safety, and durability, allowing them to seamlessly adopt Axpaxli into clinical practice.
The company will engage further with the FDA regarding next steps on the regulatory pathway for Axpaxli and will provide updates as appropriate.
William Blair analyst Lachlan Hanbury-Brown on Monday wrote, “While pulling forward a potential approval by over a year would be a significant near-term value driver for the company, several questions remain about the requirements…That said, even if the application ultimately received a CRL, we would not expect that to adversely affect the ability or timeline to resubmit following a positive SOL-R readout in 2027, so see little downside risk to an early submission at this time.”
HC Wainwright maintains Ocular Therapeutix with a Buy and raises the price forecast from $19 to $21.
OCUL Price Action: Ocular Therapeutix shares were up 29.57% at $16.30 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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