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Ocular Therapeutix Jumps on Plan to Fast-Track Vision Drug Approval

MarketDash Editorial Team
8 hours ago
Ocular Therapeutix stock surged Monday after the company announced it could file for FDA approval of its wet AMD treatment more than a year earlier than expected, potentially making it the first long-acting drug of its kind on the market.

Ocular Therapeutix Inc. (OCUL) had the kind of Monday most biotech companies dream about. The stock rocketed higher after the company said it's planning to speed up the timeline for submitting a New Drug Application (NDA) for Axpaxli (OTX-TKI), its treatment for wet age-related macular degeneration.

Here's what changed: Ocular now intends to submit its NDA following year one data from its ongoing SOL-1 Phase 3 clinical trial, assuming the results look good. That data is expected in the first quarter of 2026. Previously, the company was planning to wait for results from a second trial called SOL-R, which won't read out until the first half of 2027.

William Blair captured the significance nicely: "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."

The FDA Context That Made This Possible

So why the sudden timeline shift? It comes down to what the FDA has been saying lately. The company's announcement follows recent public statements from FDA leadership and interactions with the FDA's Division of Ophthalmology.

Historically, the FDA has been pretty strict about requiring two separate adequate and well-controlled clinical trials to demonstrate safety and efficacy for ophthalmic drugs, especially for major indications like wet AMD. But recent statements from FDA leadership suggest the agency is potentially moving toward accepting a single registrational trial for approval, provided the trial is adequately powered and controlled.

Ocular believes it's positioned to take advantage of this shift. The company has a Special Protocol Assessment (SPA) agreement with the FDA for SOL-1, and the trial uses a superiority design, which matters for regulatory purposes. Based on these factors, Ocular plans to work with the FDA to submit its NDA for Axpaxli following those year one results from SOL-1.

What Happens to the Other Trials?

Just because Ocular is planning an earlier submission doesn't mean the other trials are getting scrapped. The company expects that additional data from the continuation of SOL-1 into year two, plus results from SOL-R and SOL-X, will help clinicians and insurance companies better understand Axpaxli's efficacy, safety, and durability. That additional data should make it easier for the drug to get adopted in clinical practice once it's on the market.

The company said it will continue engaging with the FDA on the regulatory pathway and provide updates as things progress.

William Blair analyst Lachlan Hanbury-Brown noted Monday that while pulling forward a potential approval by over a year would be a significant value driver, there are still questions about what exactly the FDA will require. He added: "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."

Translation: Even if the FDA issues a Complete Response Letter (basically a rejection that says "not yet"), Ocular could still resubmit with the SOL-R data in 2027 as originally planned. So there's not much to lose by trying early.

HC Wainwright maintains Ocular Therapeutix with a Buy rating and raised its price target from $19 to $21.

OCUL Price Action: Ocular Therapeutix shares were up 29.57% at $16.30 at the time of publication on Monday, trading at a new 52-week high.

Back to News

Ocular Therapeutix Jumps on Plan to Fast-Track Vision Drug Approval

MarketDash Editorial Team
8 hours ago
Ocular Therapeutix stock surged Monday after the company announced it could file for FDA approval of its wet AMD treatment more than a year earlier than expected, potentially making it the first long-acting drug of its kind on the market.

Ocular Therapeutix Inc. (OCUL) had the kind of Monday most biotech companies dream about. The stock rocketed higher after the company said it's planning to speed up the timeline for submitting a New Drug Application (NDA) for Axpaxli (OTX-TKI), its treatment for wet age-related macular degeneration.

Here's what changed: Ocular now intends to submit its NDA following year one data from its ongoing SOL-1 Phase 3 clinical trial, assuming the results look good. That data is expected in the first quarter of 2026. Previously, the company was planning to wait for results from a second trial called SOL-R, which won't read out until the first half of 2027.

William Blair captured the significance nicely: "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."

The FDA Context That Made This Possible

So why the sudden timeline shift? It comes down to what the FDA has been saying lately. The company's announcement follows recent public statements from FDA leadership and interactions with the FDA's Division of Ophthalmology.

Historically, the FDA has been pretty strict about requiring two separate adequate and well-controlled clinical trials to demonstrate safety and efficacy for ophthalmic drugs, especially for major indications like wet AMD. But recent statements from FDA leadership suggest the agency is potentially moving toward accepting a single registrational trial for approval, provided the trial is adequately powered and controlled.

Ocular believes it's positioned to take advantage of this shift. The company has a Special Protocol Assessment (SPA) agreement with the FDA for SOL-1, and the trial uses a superiority design, which matters for regulatory purposes. Based on these factors, Ocular plans to work with the FDA to submit its NDA for Axpaxli following those year one results from SOL-1.

What Happens to the Other Trials?

Just because Ocular is planning an earlier submission doesn't mean the other trials are getting scrapped. The company expects that additional data from the continuation of SOL-1 into year two, plus results from SOL-R and SOL-X, will help clinicians and insurance companies better understand Axpaxli's efficacy, safety, and durability. That additional data should make it easier for the drug to get adopted in clinical practice once it's on the market.

The company said it will continue engaging with the FDA on the regulatory pathway and provide updates as things progress.

William Blair analyst Lachlan Hanbury-Brown noted Monday that while pulling forward a potential approval by over a year would be a significant value driver, there are still questions about what exactly the FDA will require. He added: "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."

Translation: Even if the FDA issues a Complete Response Letter (basically a rejection that says "not yet"), Ocular could still resubmit with the SOL-R data in 2027 as originally planned. So there's not much to lose by trying early.

HC Wainwright maintains Ocular Therapeutix with a Buy rating and raised its price target from $19 to $21.

OCUL Price Action: Ocular Therapeutix shares were up 29.57% at $16.30 at the time of publication on Monday, trading at a new 52-week high.

    Ocular Therapeutix Jumps on Plan to Fast-Track Vision Drug Approval - MarketDash News