SPONSORED BY AMGEN

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.1,2

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®.

Please see below for additional Important Safety Information.

~150,000 UNITS OF PAVBLU® SHIPPED IN THE FIRST 6 MONTHS OF LAUNCH

~1,000 retina specialists across
600+ practices have adopted PAVBLU®4,†,‡

*Shipped to wholesalers from Amgen.
†Adopted defined as ordered or prescribed.
‡Within first 6 months of launch.

PAVBLU® is available in both single-dose vial and prefilled plastic syringe that is silicone oil-free

Consider PAVBLU® for your appropriate patients on their next scheduled dose of afl ibercept

Data from a phase 3 double-blind study in 576 patients with wet AMD demonstrated the similarity between PAVBLU® and EYLEA® . The primary endpoint was changed from baseline in BCVA at week 8 (as measured by ETDRS letter score). The difference in mean BCVA change between the two groups was required to fall within a 90% confidence interval of (-3, 3) to establish similarity. The subject incidences of AEs, grade 3 AEs, EOIs, serious AEs, and events leading to treatment discontinuation were similar between treatment groups over 52 weeks, demonstrating a similar safety profile for EYLEA® and PAVBLU®.6

AEs, adverse events; AMD, age-related macular degeneration; BCVA, best corrected visual acuity; ETDRS, early treatment diabetic retinopathy study; EOIs, events of interests.

IMPORTANT SAFETY INFORMATION (continued)

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 click here for 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.

References: 1. PAVBLU® (aflibercept-ayyh) Prescribing Information, Amgen. 2024. 2. EYLEA® (aflibercept) prescribing information, Regeneron Pharmaceuticals Inc. 2024. 3. Data on file, Amgen; [1]; 2025. 4. Data on file, Amgen; [2]; 2025. 5. Terumo Pharmaceuticals. Press release. Terumo Pharmaceutical Solutions offers pre-fillable syringe solutions for demanding low-dose applications such as ophthalmic drugs. May 17, 2022. www.terumomedical.com/news-and-events/news/terumo-offers-prefillable-syringe-solutions.html. Accessed July 3, 2025. 6. Data on file, Amgen. [CSR 20170542]; 2024. 7. Data on file, Amgen; [3]; 2025. 8. Data on file, Amgen; [4]; 2025.

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

PAVBLU® is a registered trademark of Amgen Inc.

Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
www.amgen.com

This content is sponsored by Amgen, and Specialty Practice Network has not independently reviewed or verified the information provided by Amgen.

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