INDICATIONS

PAVBLU® (aflibercept-ayyh) 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).

PAVBLU® is not indicated for Retinopathy of Prematurity, for which Regeneron has marketing exclusivity.

PAVBLU® (aflibercept-ayyh) is indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration...Read more

PAVBLU® (aflibercept-ayyh) 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)...Read more

Indications Prescribing Information AmgenSupportPlus.com AmgenBiosimilars.com

PAVBLU®: THE FIRST available
AFLIBERCEPT BIOSIMILAR

PAVBLU® is highly similar to EYLEA® based on a totality of evidence, with no clinically meaningful differences in safety and efficacy1-4

FDA Requirements for Biosimilar Approval Totality of Evidence for PAVBLU®

Analytical characterization

Structural and functional characterization of molecular similarity5

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Comparative analytical similarity assessments demonstrated that PAVBLU® and EYLEA® have the same amino acid sequence and exhibit similar higher-order structure and biological activity.3

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Nonclinical studies

Demonstrating similar mechanism of action, potency, immunogenicity, and toxicity5

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Nonclinical assessments of pharmacology, pharmacokinetics, toxicokinetics, and safety for PAVBLU® were conducted to support similarity to EYLEA®.4

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Clinical pharmacology

Confirming biosimilarity with pharmacokinetics and pharmacodynamics5

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Results from a clinical pharmacology substudy demonstrated pharmacokinetic similarity between PAVBLU® and EYLEA®.2

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Comparative clinical study

Proving no clinically meaningful differences in safety, efficacy, or immunogenicity in a sensitive patient population5,*

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A randomized comparative clinical study in 576 subjects with neovascular (wet) age-related macular degeneration (AMD) demonstrated no clinically meaningful differences in efficacy, safety, and immunogenicity between PAVBLU® and EYLEA®.2

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Single-transition study

In the clinical study, half of patients in the EYLEA® arm were rerandomized to receive PAVBLU®. Results showed no clinically meaningful differences following transition.2

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*Adequately sensitive to detect clinically meaningful differences between the reference product and the proposed biosimilar, should they exist.

Study Design

A randomized comparative clinical study of PAVBLU® and EYLEA® in 576 patients with neovascular (wet) age-related macular degeneration (AMD)*

study design in clinical trial of patients treated with PAVBLU™ or Eylea®
  • Key inclusion criteria: Treatment-naïve neovascular (wet) AMD, age ≥ 50 years, BCVA between 34 and 73 ETDRS letters
  • Dosing: 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 injections, followed by once every 8 weeks
  • Primary endpoint: Change from baseline in BCVA at week 8 (as measured by ETDRS letter score)
    • Difference in mean BCVA change between the two groups was required to fall within a 90% confidence interval of (-3, 3) to establish similarity
  • Secondary efficacy endpoints included:
    • Proportion of patients who maintained vision at week 52 (< 15 in ETDRS letter score lost compared with baseline)
    • BCVA change from baseline through week 52 (ETDRS letter score)
    • Proportion of patients achieving a gain from baseline of ≥ 10 letters at week 8 and ≥ 15 letters at week 52, as measured by ETDRS letter score
    • CNV area (fluorescein angiography) and CST (SD-OCT) mean change from baseline through week 52
  • Secondary safety endpoints included:
    • Proportion of patients with treatment-emergent adverse events (TEAEs)
    • Proportion of patients developing binding antidrug antibodies (ADAs)

*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.

BCVA = best corrected visual acuity; CNV = choroidal neovascularization; CST = central subfield thickness; ETDRS = Early Treatment Diabetic Retinopathy Study; FA = fluorescein angiography; FP = fundus photography; IVT = intravitreal; SD OCT = spectral domain optical coherence tomography.

Patient characteristics were balanced between treatment arms

Selected Baseline
Patient Characteristics (mean) 		PAVBLU® (n = 288) EYLEA® (n = 288)
Age, years 76.0 76.0
Duration of disease, weeks 7.4 6.7
BCVA ETDRS letter score 58.9 57.6
CNV area size, mm2 8.5 9.3
CST, µm 438.4 448.8

BCVA = best corrected visual acuity; CNV = choroidal neovascularization; CST = central subfield thickness; ETDRS = Early Treatment Diabetic Retinopathy Study.

Video on Study DesignVideo on Study Design

Study Design

Watch as Dr. Awh and Dr. Sarraf review the study design of the phase 3 clinical study comparing PAVBLU® to EYLEA® in patients with neovascular (wet) AMD

Clinical Efficacy Results

PAVBLU® achieved its primary endpoint by demonstrating highly similar efficacy to EYLEA®

  • BCVA at Week 8
  • BCVA Through Week 52
  • Other Visual Acuity Endpoints
No clinically meaningful differences in mean change from baseline in BCVA
Primary Endpoint: Change in BCVA From Baseline at Week 8
BCVA improvements from baseline were maintained over time
Change in BCVA From Baseline Through Week 52
Similar proportions of patients gained and maintained vision at week 52

Proportion of subjects who maintained vision at week 52 (lost < 15 letters in ETDRS letter score compared with baseline)

Proportion of subjects who gained ≥ 10 letters of vision at week 8 (ETDRS letter score)

Proportion of subjects who gained ≥ 15 letters of vision at week 52 (ETDRS letter score)

*Estimated using ANCOVA model adjusted for the stratification factors, geographic region (East Asia, Europe, North America), and baseline BCVA as covariates.

BCVA (ETDRS letter score) data values provided for select endpoints: PAVBLU® (n = 273) mean change from baseline (59) at week 8 (+6.5) and week 52 (+7.6);  EYLEA® / PAVBLU® (n = 134) mean change from baseline (57.8) at week 8 (+5.6) and week 52 (+8.0); EYLEA® (n = 136) mean change from baseline (57.2) at week 8 (+7.6) and week 52 (+9.4).

†Half of patients in the EYLEA® arm were rerandomized to receive PAVBLU® at week 16 and the first assessment after rerandomization occurred at week 24. Patients who discontinued prior to the first assessment after rerandomization were not included in this secondary endpoint analysis.

PAVBLU® was similar to EYLEA® on all secondary endpoints

  • CST Through Week 52
  • CNV Through Week 52
PAVBLU® demonstrated no clinically meaningful differences vs EYLEA® in the reduction of retinal thickness
Mean Change in Central Subfield Thickness (CST) From Baseline
PAVBLU® demonstrated no clinically meaningful differences vs EYLEA® in the reduction of CNV area size
Mean Change in Choroidal Neovascularization (CNV) Area Size From Baseline

CST data values provided for select endpoints: PAVBLU® (n = 273) mean change from baseline (439.4) at week 8 (-145.9) and week 52 (-157.1);  EYLEA® / PAVBLU® (n = 134) mean change from baseline (458.8) at week 8 (-167.4) and week 52 (-177.4); EYLEA® (n = 136) mean change from baseline (440.3) at week 8 (-146.3) and week 52 (-159.1).

CNV area size data values provided for select endpoints: PAVBLU® (n = 273) mean change from baseline (8.6) at week 8 (-5.0) and week 52 (-6.3);  EYLEA® / PAVBLU® (n = 134) mean change from baseline (9.2) at week 8 (-5.2) and week 52 (-6.4); EYLEA® (n = 136) mean change from baseline (9.5) at week 8 (-5.5) and week 52 (-7.3).

†Half of patients in the EYLEA® arm were rerandomized to receive PAVBLU® at week 16 and the first assessment after rerandomization occurred at week 24. Patients who discontinued prior to the first assessment after rerandomization were not included in this secondary endpoint analysis.

‡Measured by spectral domain optical coherence tomography.

§Measured by fluorescein angiography.

ANCOVA = analysis of covariance; BCVA = best corrected visual acuity; CI = confidence interval; CNV = choroidal neovascularization; CST = central subfield thickness; ETDRS = Early Treatment Diabetic Retinopathy Study.

Video on Clinical Efficacy ResultsVideo on Clinical Efficacy Results

Clinical Efficacy Results

Watch as Dr. Sarraf and Dr. Awh review the clinical efficacy results from this study comparing PAVBLU® and EYLEA®

You can expect PAVBLU® to provide highly similar therapeutic benefits to EYLEA® for your patients

Clinical Safety Results

PAVBLU® demonstrated a similar safety profile to EYLEA®

Most common treatment-emergent adverse events (≥ 1%) THROUGH week 16
Treatment-Emergent Adverse Events* PAVBLU® (n = 288)% (n) EYLEA® (n = 288)% (n)
Conjunctival hemorrhage 4.2% (12) 3.8% (11)
Injection site pain 1.4% (4) 0.3% (1)
Conjunctival hyperemia 1.0% (3) 0.0% (0)
Intraocular injection complication 1.0% (3) 0.0% (0)
Posterior capsule opacification 1.0% (3) 1.0% (3)
Retinal hemorrhage 0.7% (2) 1.4% (4)
Retinal pigment epithelial tear 0.3% (1) 1.4% (4)
Visual acuity reduced 0.3% (1) 1.4% (4)
Dry eye 0.0% (0) 1.4% (4)
Vitreous detachment 0.0% (0) 1.0% (3)
Vitreous floaters 0.0% (0) 1.0% (3)
Observed THROUGH week 16
  • 1 patient (0.3%) on PAVBLU® developed antidrug antibodies compared to 4 patients (1.4%) on EYLEA®
  • The incidence of any event of interest (EOI) in the PAVBLU® and EYLEA® treatment groups was similar (6 [2.1%] and 3 [1.0%], respectively); the incidence, type, and severity of events within each of the individual EOIs was also similar between treatment groups†

Transitioning from EYLEA® to PAVBLU® did not
have a clinically meaningful impact on safety for patients

Most common treatment-emergent adverse events (≥ 1%) Post Week-16 rerandomization THROUGH WEEK 52
Treatment-Emergent Adverse Events* PAVBLU® (n = 273)% (n) Eylea®/PAVBLU® Eylea® / PAVBLU® (n = 133)% (n) Eylea® (n = 136)% (n)
Visual acuity reduced 2.9% (8) 3.8% (5) 0.7% (1)
Cataract 2.2% (6) 0.8% (1) 2.2% (3)
Retinal hemorrhage 1.8% (5) 3.0% (4) 0.7% (1)
Chalazion 1.1% (3) 0.0% (0) 0.0% (0)
Conjunctival hemorrhage 1.1% (3) 6.0% (8) 3.7% (5)
Macular fibrosis 1.1% (3) 0.0% (0) 0.7% (1)
Subretinal fluid 1.1% (3) 0.8% (1) 0.0% (0)
Vitreous detachment 1.1% (3) 0.8% (1) 0.0% (0)
Posterior Capsule Opacification 0.7% (2) 0.8% (1) 2.2% (3)
Visual Impairment 0.7% (2) 0.8% (1) 1.5% (2)
Vitreous floaters 0.7% (2) 1.5% (2) 1.5% (2)
Macular edema 0.4% (1) 1.5% (2) 0.7% (1)
Ocular hypertension 0.4% (1) 1.5% (2) 0.0% (0)
Ocular hyperemia 0.0% (0) 0.0% (0) 1.5% (2)
Injection site pain 1.1% (3) 0.8% (1) 0.0% (0)
Sensation of foreign body 0.4% (1) 0.8% (1) 1.5% (2)
Observed in the 52-week study
  • Overall and ocular adverse events, prespecified events of interest, and immunogenicity were similar between PAVBLU® and EYLEA®
  • No instances of retinal vasculitis or endophthalmitis
  • The incidence of intraocular inflammation was reported in < 1% of patients in all arms

Note: Only treatment-emergent adverse events were summarized. For each adverse event of interest, subjects were included only once, even if they experienced multiple events for that adverse event of interest.

*Adverse event of interest identified using MedDRA v25.1 terms.

†Adverse events of interest (EOI) prespecified for this study were endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events.

Video on Clinical Safety ResultsVideo on Clinical Safety Results

Clinical Safety Results

Watch as Dr. Sarraf and Dr. Awh review the clinical safety results from this comparative study

Comparable safety profile was demonstrated across
all treatment groups, including patients who transitioned
from EYLEA® to PAVBLU®

Initial real-world evidence from 1,000 eyes treated with PAVBLU®: Analysis of 3-month safety and vision outcomes1

Study design: A retrospective, observational study of 1,000 eyes treated with PAVBLU® using electronic medical records (EMRs) from retina practices in the United States to describe demographics, utilization, visual outcomes (best recorded visual acuity), and safety analysis (adverse events of special interest) among 989 adult patients diagnosed with nAMD, RVO, DME, or DR. Records from December 1, 2024, to October 31, 2025, were included in this interim analysis, focusing on eyes with ≥ 84 days of follow-up. Bilaterally treated eyes from the same patient were included and analyzed as independent study eyes. Data were extracted from EMRs of patients seen by 175 retina specialists at 146 locations across 24 states using Structured Query Language (SQL). The index date was defined for each eye as the date of the first documented PAVBLU® injection.

Important considerations: 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 planned primary assessment timepoint of ~ 3 months limits conclusions on longer-term visual outcomes, durability, and rare adverse events. Analysis of the full 12-month follow-up period is pending.

Patient Population
989 patients with nAMD, RVO, DME, DR
1,000 consecutively treated eyes
3,730 intravitreal injections of PAVBLU®
≥ 84 days follow-up from first injection
Disease Distribution (n = eyes)
Neovascular (wet) age-related macular degeneration (nAMD) (n = 578) 58%
Macular edema following retinal vein occlusion (RVO) (n = 193) 19%
Diabetic macular edema (DME) (n = 162) 16%
Diabetic retinopathy (DR) (n = 67) 7%

Visual acuity observations in the 3-month follow-up period*

Among eyes transitioned from previous anti-VEGF therapy:

91% of eyes (n = 906) transitioned from prior therapy
Median number of prior anti-VEGF injections = 21
(8-46 IQR range)
Best Recorded Visual Acuity (mean)
Baseline: 0.4 logMAR (~ 20/50)†
≥ 3 Months: 0.4 logMAR (~ 20/50)†
Among-eyes-transitioned
Among-eyes-transitioned

Among anti-VEGF treatment-naïve eyes:

9% of eyes (n = 94) were anti-VEGF treatment-naïve
Small sample sizes in subgroups limit interpretability
Best Recorded Visual Acuity (mean)
Baseline: 0.5 logMAR (~ 20/63)†
≥ 3 Months: 0.4 logMAR (~ 20/50)†
Among-anti-VEGF-treatment
Among-anti-VEGF-treatment

*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.

†Visual acuity unit conversion logMAR to Snellen (feet) and ETDRS letters.2

ADVERSE EVENTS OF SPECIAL INTEREST OBSERVED AMONG 3,730 INJECTIONS1
  • Two confirmed AESIs, both uveitis (iritis), occurred and resolved
  • No instances of vitreous cells, endophthalmitis, retinal detachment, retinal vasculitis, or vitreous hemorrhage observed

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.‡

‡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.

APEX Study: Real-World Safety Analysis Based on More Than 52,000 PAVBLU® (aflibercept-ayyh) Injections3

An investigator-led, observational analysis of a large safety dataset provides an assessment of real-world safety outcomes from 11,529 patients treated with PAVBLU® (aflibercept-ayyh) 2 mg intravitreal injections. The data from 15,143 eyes (including 4,070 eyes with > 6 months of follow-up) were collected from 4 retina centers in the United States and identified through manual and keyword search from a large database.

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.

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.

These real-world data provide initial insight into the use of PAVBLU® in routine clinical practice

Study Design

Important Safety Information

CONTRAINDICATIONS
  • 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.
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.
  • 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).
  • 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.
ADVERSE REACTIONS
  • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with aflibercept
    including endophthalmitis and retinal detachment.
  • 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.
  • 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.
Please see full Prescribing Information for PAVBLU.

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.

INDICATIONS

PAVBLU® (aflibercept-ayyh) 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).

PAVBLU® is not indicated for Retinopathy of Prematurity, for which Regeneron has marketing exclusivity.

Important Safety Information

CONTRAINDICATIONS
  • 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.

EYLEA® is a registered trademark of Regeneron Pharmaceuticals, Inc.

PAVBLU® is a registered trademark of Amgen Inc.

Reference: Friedman S, London N, Hamouz J, et al. Ophthalmol Retina. 2026;10:152-164.

Reference: Friedman S, London N, Hamouz J, et al. Ophthalmol Retina. 2026;10:152-164.

Reference: Data on file, Amgen. [CSR 20170542]; 2024.

References: 1.  PAVBLU® (aflibercept-ayyh) prescribing information, Amgen. 2. Friedman S, London N, Hamouz J, et al. Ophthalmol Retina. 2026;10:152-164. 3. Seo N, Guan Z, Wang T, et al. Ophthalmol Ther. 2024;13:1303-1320. 4. Seo N, Kuhns S, Andrews D, Colbert A, Chow V, Liu J. Ophthalmol Ther. 2025;14:85-101. 5. US Food and Drug Administration. www.fda.gov/media/82647/download. Accessed February 25, 2026.

References: 1. Servin AE, et al. Ophthalmol Ther. 2026. doi:10.1007/s40123-026-01400-6. 2. Gregori N, Feuer W, Rosenfeld P. Retina. 2010;30:1046-1050. 3. Sharma A, Khanani AM, Eichenbaum D, et al. Eye (Lond). Published online March 2, 2026:1-4. doi:10.1038/s41433-026-04327-1.