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| INDICATIONS |
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| PAVBLU® is indicated for the treatment of Neovascular (Wet) Age‑Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
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| PAVBLU® is not indicated for Retinopathy of Prematurity, for which Regeneron has marketing exclusivity. |
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| IMPORTANT SAFETY INFORMATION |
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| CONTRAINDICATIONS |
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PAVBLU® is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in PAVBLU®.
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| WARNINGS AND PRECAUTIONS |
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Intravitreal injections, including those with aflibercept products, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering PAVBLU®
. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
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Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with aflibercept products. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
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| Please see additional Important Safety Information below. |
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| PAVBLU® ACHIEVED ITS PRIMARY ENDPOINT BY DEMONSTRATING HIGHLY SIMILAR EFFICACY TO EYLEA® (aflibercept)3 |
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| Data from a comparative clinical double‑blind study in 576 patients with wet AMD demonstrated the similarity between PAVBLU® and EYLEA®. The primary endpoint was change from baseline in BCVA at week 8 (as measured by ETDRS letter score).3 |
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| Results from the sensitivity analyses for primary and secondary efficacy endpoints over the 52‑week study duration demonstrated similarity in clinical efficacy.3 |
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Neovascular (wet) AMD in the study eye with active treatment-naïve subfoveal CNV lesions secondary to neovascular (wet) AMD, including juxtafoveal lesions that affect the fovea as confirmed with SD OCT, FA, and/or FP in the study eye. |
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| Visual acuity observations in the 3-month follow-up period1,† |
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| AMONG EYES TRANSITIONED FROM PREVIOUS ANTI‑VEGF THERAPY: |
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| AMONG ANTI‑VEGF TREATMENT NAÏVE EYES: |
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Analyses of Best Recorded Visual Acuity (BRVA) outcomes focused on eyes with at least 84 days of follow-up after the index date. BRVA, recorded as Snellen visual acuity and converted to logMAR for analysis, was assessed at baseline and at ≥ 84 days of follow-up. Continuous variables were summarized using means and standard deviations or medians and interquartile ranges (IQRs), as appropriate.1 |
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Visual acuity unit conversion logMAR to Snellen (feet) and ETDRS letters.4 |
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| ADVERSE EVENTS OF SPECIAL INTEREST OBSERVED AMONG 3,730 INJECTIONS1 |
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Two confirmed AESIs, both uveitis (iritis), occurred and resolved
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No instances of vitreous cells, endophthalmitis, retinal detachment, retinal vasculitis, or vitreous hemorrhage observed
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| Defined AESIs were endophthalmitis, retinal vasculitis, iritis, vitreous cells, retinal detachment, and vitreous hemorrhage. The number of injections in the study is insufficient to estimate the rate of these adverse events of special interest.§ |
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Adverse events of special interest (AESIs), defined as adverse events occurring within 21 days of any PAVBLU® treatment, were identified in EMRs according to clinical and imaging findings and supported by ICD-10 codes, with manual chart reviews performed by investigating physicians to validate extracted data. Both cases of iritis resolved with topical steroid treatment. |
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| The APEX real‑world safety analysis of 52,374 PAVBLU® injections reported no new safety findings in this dataset; ocular adverse events reported included ocular hypertension, endophthalmitis, intraocular inflammation, retinal vasculitis, and retinal vascular occlusion. |
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| Important Considerations: The data were aggregated at the injection-level rather than patient‑level, meaning the severity, management, and clinical outcomes of ocular events could not be evaluated in detail. This descriptive study was not designed to compare PAVBLU with other anti-VEGF therapies, there was no concurrent comparator arm, and patients were not randomized. The reported cases of endophthalmitis were considered injection-related ocular adverse events, rather than drug-attributable adverse reactions.
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The data from the two real world studies described above provide initial insight into the use of PAVBLU® in routine clinical practice.
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| INDICATIONS |
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| PAVBLU® is indicated for the treatment of Neovascular (Wet) Age‑Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
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| PAVBLU® is not indicated for Retinopathy of Prematurity, for which Regeneron has marketing exclusivity. |
|
| IMPORTANT SAFETY INFORMATION |
|
| CONTRAINDICATIONS |
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| • |
PAVBLU® is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in PAVBLU®.
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| WARNINGS AND PRECAUTIONS |
|
| • |
Intravitreal injections, including those with aflibercept products, have been associated with
endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or
without occlusion. Proper aseptic injection technique must always be used when
administering PAVBLU®. Patients and/or caregivers should be instructed to report
any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or
retinal vasculitis without delay and should be managed appropriately.
|
|
| • |
Acute increases in intraocular pressure have been seen within 60 minutes of
intravitreal injection, including with aflibercept products. Sustained increases in intraocular
pressure have also been reported after repeated intravitreal dosing with VEGF
inhibitors. Intraocular pressure and the perfusion of the optic nerve head should
be monitored and managed appropriately.
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There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal
use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke,
nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
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The incidence of reported thromboembolic events in wet AMD studies during the
first year was 1.8% (32 out of 1824) in the combined group of patients treated
with aflibercept compared with 1.5% (9 out of 595) in patients treated with
ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the
aflibercept group compared with 3.2% (19 out of 595) in the ranibizumab group.
The incidence in the DME studies from baseline to week 52 was 3.3% (19 out
of 578) in the combined group of patients treated with aflibercept compared with
2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence
was 6.4% (37 out of 578) in the combined group of patients treated with aflibercept
compared with 4.2% (12 out of 287) in the control group. There were no reported
thromboembolic events in the patients treated with aflibercept in the first six months
of the RVO studies.
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| ADVERSE REACTIONS |
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Serious adverse reactions related to the injection procedure have occurred in
<0.1% of intravitreal injections with aflibercept including endophthalmitis and
retinal detachment.
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The most common adverse reactions (≥5%) reported in patients receiving
aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment,
vitreous floaters, and intraocular pressure increased.
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Patients may experience temporary visual disturbances after an intravitreal
injection with PAVBLU® and the associated eye examinations. Advise patients not
to drive or use machinery until visual function has recovered sufficiently.
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| Please see full Prescribing Information for PAVBLU®. |
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You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
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| References: 1. Servin AE, et al. Ophthalmol Ther. 2026. doi:10.1007/s40123-026-01400-6. 2. Sharma A, Khanani AM, Eichenbaum D, et al. Eye (Lond). Published online March 2, 2026:1‑4. 3. Data on file, Amgen.
[CSR 20170542]; 2024. 4. Gregori N, Feuer W, Rosenfeld P. Retina. 2010;30:1046-1050.
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