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Dazdotuftide inferior to prednisolone for uveitis inflammation but superior IOP safety in phase 3 trialNew Eye Drops Control Inflammation Without the Glaucoma Risk

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Key Takeaway
Consider dazdotuftide where steroid-induced IOP elevation is a concern, recognizing inferior inflammation control versus prednisolone.

This randomized, double-masked, multicenter, active-controlled phase 3 trial evaluated the steroid-free anti-inflammatory dazdotuftide (TRS01 eye drops) in active anterior noninfectious uveitis (NIU). The full analysis set included 136 adult (≤75 years) and pediatric patients with or without uveitic glaucoma, on stable NIU therapy or treatment-naïve, with Anterior Chamber Cell (ACC) Grade 2 or 3 on Visual Analog Scale in the study eye. Mean age was 43 years in the TRS01 arm and 42 years in the prednisolone acetate arm.

Patients were randomized 2:1 to topical TRS01 1% or prednisolone acetate 1%, administered 4 times daily for 28 days. The primary outcomes addressed resolution of inflammation (ACC = 0), clinically meaningful improvement, ocular pain, flare, and IOP changes at Day 28.

For inflammation resolution, 48% of TRS01 vs 68% of prednisolone patients achieved ACC Grade = 0 at Day 28 (95.1% CI: -0.37, -0.02; P = .0311). Clinically meaningful improvement (ACC = 0 or 1, ≤5 cells) was reached in 64% vs 89% of patients, respectively (95.1% CI: -0.33, -0.06; P = .0049). TRS01 was thus inferior to topical steroids for controlling ACC but noninferior for flare and ocular pain.

On safety, TRS01 demonstrated a superior IOP profile versus topical steroids. Among patients reaching ACC = 0, TRS01-treated patients had statistically significant IOP safety advantages, both for change from baseline and at each evaluated IOP threshold (P < .05). Broader adverse event data were not detailed in the abstract.

The authors conclude TRS01 may serve as an effective, steroid-free option addressing the unmet need for uveitis treatment without steroid-associated IOP elevation risk, though its inferior anti-inflammatory potency versus prednisolone warrants consideration in treatment selection.

Imagine waking up with a painful, red eye that makes light feel like a knife. You need drops to calm the swelling, but the standard treatment comes with a scary side effect: it can raise the pressure in your eye, putting you at risk for glaucoma and permanent vision loss.

For millions of people with uveitis, this is a daily worry. They need relief, but they also fear the cure.

Now, a new study offers a promising alternative. A steroid-free eye drop called dazdotuftide (TRS01) is showing it can reduce inflammation without the dangerous pressure spikes that steroids often cause.

Uveitis is swelling inside the eye. It can cause pain, redness, and blurry vision. If not treated, it can lead to serious problems like cataracts, glaucoma, and even blindness.

It affects people of all ages, including children. About 1 in 10 cases of uveitis are in kids.

The standard treatment is steroid eye drops. They work well to reduce swelling, but they have a major downside. Over time, steroids can raise the pressure inside the eye. This is called intraocular pressure (IOP). High IOP can damage the optic nerve, the cable that connects your eye to your brain.

For some patients, this means a tough choice: control the inflammation or protect their optic nerve.

The Old Way vs. The New Way

For decades, steroids have been the go-to treatment for noninfectious uveitis. They are effective, but their side effects are well-known.

Doctors often have to monitor patients closely, sometimes adding more medications to lower eye pressure. In some cases, patients need surgery.

But here’s the twist: what if a drug could calm inflammation without touching the pressure in your eye?

That’s the question researchers set out to answer with dazdotuftide. It’s a new type of anti-inflammatory drug. It is not a steroid. The hope is that it can provide the same relief without the same risks.

Think of inflammation in the eye like a fire. Steroids are like a fire hose—they put out the fire, but they can also flood the house and cause other problems.

Dazdotuftide is more like a targeted fire extinguisher. It aims to put out the fire without soaking everything else.

The drug works by blocking a specific pathway in the body’s immune system. This pathway is a key driver of inflammation. By targeting it directly, dazdotuftide can reduce swelling without the broad effects of steroids.

This targeted approach is why researchers think it might avoid raising eye pressure.

Researchers ran a large, high-quality clinical trial. They enrolled 136 adults and children with active uveitis. The patients were randomly assigned to use either dazdotuftide eye drops or standard steroid eye drops four times a day for 28 days.

The study was "double-masked," meaning neither the patients nor the doctors knew which drop was which. This helps remove bias. The trial was also "active-controlled," meaning it was compared against the current standard treatment, not a placebo.

The results showed a clear trade-off.

The steroid drops were better at completely clearing the inflammation from the front of the eye. On day 28, 68% of steroid users had zero cells in their eye, compared to 48% of dazdotuftide users.

But here’s where the story changes.

When it came to other important symptoms—like eye pain and flare (a measure of protein in the fluid)—dazdotuftide performed just as well as the steroids.

And the biggest difference was in eye pressure.

The pressure-safe advantage

Patients using dazdotuftide had a significantly lower risk of high eye pressure. In fact, the drug showed a superior safety profile for IOP compared to steroids.

For patients who did achieve complete clearance of inflammation with dazdotuftide, the safety benefits were even more pronounced. They had statistically better outcomes in eye pressure changes compared to those on steroids.

This suggests that for patients who are sensitive to steroid-induced pressure spikes, dazdotuftide could be a game-changer.

This doesn’t mean this treatment is available yet.

This study addresses a critical unmet need in ophthalmology. While steroids remain the most effective at clearing inflammation quickly, their side-effect profile limits their long-term use. A steroid-free option that offers comparable control of pain and flare, with a superior safety profile for eye pressure, could become a valuable tool for doctors. It may allow for longer-term management of uveitis without the constant fear of glaucoma.

If you or a loved one has uveitis and struggles with high eye pressure from steroids, this research is encouraging. However, dazdotuftide is still an investigational drug. It is not yet approved by the FDA or available at your pharmacy.

Do not stop your current medications. If you are concerned about the side effects of your treatment, talk to your ophthalmologist. They can help you weigh the risks and benefits of your current plan.

This study has some important limitations. It was a phase 3 trial, which is a late-stage study, but it was still relatively small with 136 patients. The treatment period was only 28 days, so we don’t know how well the drug works or how safe it is over many months or years.

Also, while dazdotuftide was not as good as steroids at completely clearing inflammation in this short trial, it still provided meaningful relief for many patients.

The next step is for the drug’s manufacturer to submit these results to regulatory agencies like the FDA for approval. If approved, dazdotuftide could become a new standard of care for certain patients with uveitis.

Research like this takes time, but it moves us closer to treatments that are both effective and safe. For patients living with uveitis, that future is looking brighter.

Study Details

Study typeRct
Sample sizen = 136
EvidenceLevel 2
Follow-up900.0 mo
PublishedApr 2026
View Original Abstract ↓
PURPOSE: To evaluate the safety and efficacy of dazdotuftide (TRS01 eye drops), a novel, steroid-free, anti-inflammatory drug in patients with active anterior noninfectious uveitis (NIU), following previous studies in which it had shown a favorable risk/benefit profile with regards to safety and specifically intraocular pressure (IOP) safety profile. DESIGN: A randomized, double-masked, multicenter, active-controlled phase 3 trial. PARTICIPANTS: Adults (≤75 years of age) and pediatric patients, with active anterior NIU, with or without uveitic glaucoma, on stable medical therapy for NIU or who had received no prior therapy, requiring further treatment for an active NIU flare-up. Patients eligible for inclusion had Anterior Chamber Cell (ACC) Grade 2 or Grade 3 on Visual Analog Scale in the study eye. METHODS: Patients were randomized 2:1 to topical TRS01 1% or prednisolone acetate 1% administered 4 times daily for 28 days. Key ocular assessments included slit-lamp examination, ocular pain, Best Corrected Visual Acuity, IOP and dilated ophthalmoscopy. MAIN OUTCOME MEASURES: Resolution of inflammation (ACC = 0), clinically meaningful improvement of ACC, ocular pain, flare, and IOP changes on Day 28. RESULTS: The Full Analysis Set included 136 patients; the mean age was 43 years in the TRS01 arm and 42 years in the prednisolone acetate arm. 48% of TRS01 vs 68% of prednisolone acetate patients achieved ACC Grade = 0 on Day 28 (95.1% Confidence Interval (CI): -0.37, -0.02; P = .0311) and 64% of TRS01 vs 89% prednisolone acetate patients experienced clinically meaningful improvement of ACC Grade = 0 or 1, ie, ≤5 cells (95.1% CI: -0.33, -0.06; P = .0049). While TRS01 was found to be inferior to topical steroids to control ACC, TRS01 was noninferior to topical steroids to control flare and ocular pain and exhibited a superior IOP safety compared to topical steroids. For patients who reached ACC = 0, TRS01-treated patients benefited from statistically significantly improved safety outcomes for IOP (including change from baseline and at each IOP threshold evaluated [P < .05]) versus steroid-treated patients. CONCLUSIONS: TRS01 offers the potential to serve as an effective and safe treatment option in NIU that meets the urgent need for a drug that controls inflammation without the steroids' associated risk of IOP elevation.
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