Vabysmo Drug Information

Generic name: FARICIMAB

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Uses of Vabysmo

Neovascular (wet) Age-Related Macular

Degeneration (nAMD)

Diabetic Macular Edema (DME)

Macular Edema Following Retinal Vein Occlusion (RVO)

Dosage & Administration of Vabysmo

Preparation for Administration - Prefilled Syringe Image Image Image Image Image Image Image Figure A Figure B Figure C Figure D Figure E

Preparation for Administration - Vial

Injection Procedure

The intravitreal injection procedure must be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent), and the availability of sterile paracentesis equipment (if required). Adequate anesthesia and a broad-spectrum microbicide should be administered prior to the injection. Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.05 mL.

Note for the prefilled syringe: Do not recap or detach the injection filter needle from the syringe. Any unused drug product or waste material should be disposed of in accordance with local regulations. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.

Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. Following intravitreal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., vision loss, eye pain, redness of the eye, photophobia, blurring of vision) without delay.

Each syringe should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before VABYSMO is administered to the other eye.

Before you start
	Read all the instructions carefully before using VABYSMO.
The VABYSMO carton includes:
	A sterile prefilled syringe in a sealed tray. The prefilled syringe is for treatment of a single eye.
	A sterile injection filter needle (30-gauge × ½ inch, Extra Thin Wall) with an integrated filter in the hub. The injection filter needle is for single use only.
	Only use the provided injection filter needle for the administration.
	VABYSMO should be refrigerated at temperatures between 2°C to 8°C (36°F to 46°F). Do not freeze.
	Allow VABYSMO to reach room temperature, 20°C to 25°C (68°F to 77°F) before proceeding with the administration.
	Prior to use, keep the sealed tray in the original carton to protect the prefilled syringe from light. The prefilled syringe may be kept at room temperature in the original carton for up to 24 hours.
	VABYSMO should be inspected visually prior to administration.
	Do not use if the carton seals have been tampered with.
	Do not use if the packaging, prefilled syringe, injection filter needle is expired, damaged, or have been tampered with.
	Do not use if the injection filter needle is missing.
	Do not remove the finger grip from the syringe.
	Do not use if the syringe cap is detached from the Luer lock.
	Do not use if particulates, cloudiness, or discoloration are visible. VABYSMO is a clear to opalescent and colorless to brownish-yellow liquid solution.
Prefilled Syringe Description

	Figure A
Note: the dose must be set to the 0.05 mL dose mark.
Use aseptic technique to carry out the following preparation steps:
Open Tray and Remove Syringe Cap
1	Peel the lid off the syringe tray and aseptically remove the prefilled syringe.
2	Hold the syringe by the white collar; snap off the syringe cap ( see Figure B ).
	Do not twist off the cap.

	Figure B
Attach Injection Filter Needle
3	Aseptically remove the provided injection filter needle from its packaging.
4	Aseptically and firmly attach the injection filter needle onto the syringe Luer lock ( see Figure C ).

	Figure C
5	Carefully remove the needle cap by pulling it straight off.
Dislodge Air Bubbles
6	Hold the syringe with the injection filter needle pointing up. Check the syringe for air bubbles.
7	If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top ( see Figure D ).

	Figure D
Expel Air and Adjust the Dose
8	Hold the syringe at eye level and slowly push the plunger rod until the lower edge of the rubber stopper's dome is aligned with the 0.05 mL dose mark ( see Figure E ). This will expel the air and the excess solution and set the dose to 0.05 mL.
	Ensure that the injection is given immediately after preparation of the dose.

	Figure E

Before you start
	Read all the instructions carefully before using VABYSMO.
	The VABYSMO kit includes a glass vial and transfer filter needle. The glass vial is for a single dose only. The filter needle is for treatment of a single eye.
	VABYSMO should be stored refrigerated at temperatures between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake.
	Allow VABYSMO to reach room temperature, 20°C to 25°C (68°F to 77°F) before proceeding with the administration. Keep the vial in the original carton to protect from light.
	The VABYSMO vial may be kept at room temperature for up to 24 hours.
	The VABYSMO vial should be inspected visually for particulate matter and discoloration prior to administration. VABYSMO is a clear to opalescent and colorless to brownish-yellow liquid solution. Do not use if particulates, cloudiness, or discoloration are visible. Do not use if the packaging, vial and/or transfer filter needle are expired, damaged, or have been tampered with (see Figure F ).

	Figure F
Use aseptic technique to carry out the preparation of the intravitreal injection.
1	Gather the following supplies: One VABYSMO vial (included) One sterile 5-micron blunt transfer filter needle 18-gauge × 1½ inch (included) One sterile 1 mL Luer lock syringe with a 0.05 mL dose mark ( not included ) Note that a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles. One sterile injection needle 30-gauge × ½ inch ( not included ) Alcohol swab ( not included ).
2	To ensure all liquid settles at the bottom of the vial, place the vial upright on a flat surface (for about 1 minute) after removal from packaging (see Figure G ). Gently tap the vial with your finger (see Figure H ), as liquid may stick to the top of the vial.

	Figure G	Figure H
3	Remove the flip-off cap from the vial (see Figure I ) and wipe the vial septum with an alcohol swab (see Figure J ).

	Figure I	Figure J
4	Aseptically and firmly attach the included 18-gauge × 1½ inch transfer filter needle onto a 1 mL Luer lock syringe (see Figure K ).

	Figure K
5	Using aseptic technique, push the transfer filter needle into the center of the vial septum (see Figure L ), push it all the way in, then tilt the vial slightly so that the needle touches the bottom edge of the vial (see Figure M ).

	Figure L	Figure M
6	Hold the vial slightly inclined and slowly withdraw all the liquid from the vial (see Figure N ). Keep the bevel of the transfer filter needle submerged in the liquid, to avoid introduction of air.

	Figure N
7	Ensure that the plunger rod is drawn sufficiently back when emptying the vial, in order to completely empty the transfer filter needle (see Figure N ).
8	Disconnect the transfer filter needle from the syringe and dispose of it in accordance with local regulations.
	Do not use the transfer filter needle for the intravitreal injection.
9	Aseptically and firmly attach a 30-gauge × ½ inch injection needle onto the Luer lock syringe (see Figure O ).

	Figure O
10	Carefully remove the plastic needle shield from the needle by pulling it straight off.
11	To check for air bubbles, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure P ).

	Figure P
12	Carefully expel the air from the syringe and needle, and slowly depress the plunger to align the rubber stopper tip to the 0.05 mL dose mark. The syringe is ready for the injection (see Figure Q ). Ensure that the injection is given immediately after preparation of the dose.

	Figure Q

Side Effects of Vabysmo

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to VABYSMO in 2,567 patients, which constituted the safety population in six Phase 3 studies. Table 1: Common Less common adverse reactions reported in < 1% of the patients treated with VABYSMO were corneal abrasion, eye pruritus, ocular hyperemia, blurred vision, sensation of foreign body, endophthalmitis, conjunctival hyperaemia, visual acuity reduced, visual acuity reduced transiently, vitreous hemorrhage, retinal tear and rhegmatogenous retinal detachment.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of VABYSMO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye disorders: retinal vasculitis with or without retinal vascular occlusion.

Table 1: Common Adverse Reactions (≥ 1%)
Adverse Reactions	VABYSMO			Active Control (aflibercept)
Adverse Reactions	AMD N=664	DME N=1,262	RVO N=641	AMD N=662	DME N=625	RVO N=635
Cataract	3%	15%	< 1%	2%	12%	1%
Conjunctival hemorrhage	7%	8%	3%	8%	7%	4%
Vitreous detachment	3%	5%	2%	3%	4%	2%
Vitreous floaters	3%	4%	2%	2%	3%	2%
Retinal pigment epithelial tear AMD only	3%			1%
Intraocular pressure increased	3%	4%	1%	2%	3%	3%
Eye pain	3%	3%	< 1%	3%	3%	< 1%
Intraocular inflammation Including iridocyclitis, iritis, uveitis, vitritis	2%	1%	1%	1%	1%	< 1%
Eye irritation	1%	< 1%	< 1%	< 1%	1%	< 1%
Lacrimation increased	1%	1%	0	1%	< 1%	< 1%
Ocular discomfort	1%	1%	< 1%	< 1%	< 1%	< 1%

Warnings & Cautions for Vabysmo

Endophthalmitis and Retinal Detachments

Intravitreal injections, including Vabysmo, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering Vabysmo. Patients should be instructed to report any signs or symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure

Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with Vabysmo. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Vabysmo clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported ATEs in the RVO studies during the first 6 months was 1.1% (7 out of 641) in patients treated with Vabysmo compared with 1.4% (9 out of 635) in patients treated with aflibercept.

Retinal

Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo. Discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Pregnancy Safety for Vabysmo

Pregnancy Risk Summary There are no adequate and well-controlled studies of VABYSMO administration in pregnant women. Administration of VABYSMO to pregnant monkeys throughout the period of organogenesis resulted in an increased incidence of abortions at intravenous (IV) doses 158 times the human exposure (based on C max ) of the maximum recommended human dose. Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development.

VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. Data Animal Data An embryo fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. A non-dose dependent increase in pregnancy loss (abortions) was observed at both doses evaluated.

Serum exposure (C max ) in pregnant monkeys at the low dose of 1 mg/kg was 158 times the human exposure at the maximum recommended intravitreal dose of 6 mg once every 4 weeks. A no observed adverse effect level (NOAEL) was not identified in this study.

Pediatric Use of Vabysmo

Pediatric Use The safety and efficacy of VABYSMO in pediatric patients have not been established.

Contraindications for Vabysmo

Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections.

Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation.

Hypersensitivity VABYSMO is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Clinical Studies of Vabysmo

Neovascular (wet) Age-Related Macular

Degeneration (nAMD) The safety and efficacy of VABYSMO were assessed in two randomized, multi-center, double-masked, active comparator-controlled, 2-year studies (TENAYA – NCT03823287 and LUCERNE – NCT03823300) in patients with nAMD. A total of 1,329 newly diagnosed, treatment-naïve patients were enrolled in these studies, and 664 patients received at least one dose of VABYSMO. Patient ages ranged from 50 to 99 with a mean of 75.9 years.

The studies were identically designed two year studies. However, the utility of these criteria to guide dosing intervals has not been established. These percentages are reflective of what happened within the conduct of these trials and indicate that some patients did well on two doses spaced 16 weeks apart, or three doses spaced 12 weeks apart, but the percentages may not be generalizable to a broader nAMD population for a variety of reasons.

The inclusion/exclusion criteria limited enrollment to a select subset of treatment-naïve, newly diagnosed nAMD patients and there is no empirical data that a similar magnitude would be observed if eligibility criteria allowed for broader enrollment. The disease activity criteria, which was instrumental in determining dose frequency, is unvalidated. Stricter criteria would have changed how patients were treated resulting in different percentages of subjects in each dose interval cohort.

There was not a similarly dosed aflibercept arm for comparison, which makes the percentages difficult to interpret. Both studies demonstrated non-inferiority to the comparator control (aflibercept) at the primary endpoint, defined as the mean change from baseline in Best Corrected Visual Acuity (BCVA) when averaged over the week 40, 44, and 48 visits and measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter chart. The primary endpoint analysis was a non- inferiority comparison for the mean change in BCVA between the aflibercept and the VABYSMO arm.

The lower bound of the 95% confidence interval for the mean change in BCVA could not be lower than minus 4 letters to declare non-inferiority. In both studies, VABYSMO treated patients had a non-inferior mean change from baseline in BCVA compared to patients treated with aflibercept. Detailed results of both studies are shown in Table 2, Figure 1, and Figure 2 below.

The clinical efficacy for the second year of the study has not been reviewed. Figure 1 Figure 2

Diabetic Macular Edema (DME)

The safety and efficacy of VABYSMO were assessed in two randomized, multi-center, double-masked, active comparator-controlled 2-year studies (YOSEMITE – NCT03622580 and RHINE – NCT03622593) in patients with DME. A total of 1,891 diabetic patients were enrolled in the two studies with a total of 1,262 patients treated with at least one dose of VABYSMO. Patient ages ranged from 24 to 91 with a mean of 62.2 years.

The overall population included both anti-VEGF naïve patients (78%) and patients who had been previously treated with a VEGF inhibitor prior to study participation (22%). Patients were randomized in a 1:1:1 ratio to one of three treatment regimens: 1 aflibercept Q8W, patients received fixed aflibercept 2 mg administered every 8 weeks (Q8W) after the first five monthly doses; 2 VABYSMO Q8W, patients received fixed VABYSMO 6 mg administered Q8W after the first six monthly doses; and 3 VABYSMO Variable, patients received VABYSMO 6 mg administered every 4 weeks for at least 4 doses and until the central subfield thickness (CST) of the macula measured by optical coherence tomography was less than approximately 325 microns, then the interval of dosing was modified by up to 4 week interval extensions or reductions of up to 8 week interval increments based on CST and visual acuity disease activity criteria at study drug dosing visits. At Week 56, 32% of patients had completed at least one Q12W interval followed by one full Q16W interval.

Seventeen percent (17%) of patients were treated on Q8W and/or Q4W dosing intervals through Week 56 (7% only on Q4W). The disease activity criteria, which were instrumental in determining dose frequency, are unvalidated. Both studies demonstrated non-inferiority to the comparator control (aflibercept) at the primary endpoint, defined as the mean change from baseline in BCVA at year 1 (average of the Week 48, 52, and 56 visits), measured by the ETDRS Letter Score.

Detailed results of both studies are shown in Table 3, Figure 3, and Figure 4 below. Table 3: Efficacy Results at Figure 3: Mean Change in Visual Acuity from Baseline to Year 2 (Week 100) in YOSEMITE Figure 4: Mean Change in Visual Acuity from Baseline to Year 2 (Week 100) in RHINE Treatment effects in the subgroup of patients who were anti-VEGF naïve prior to study participation were similar to those observed in the overall population. Treatment effects in evaluable subgroups (e.g., by age, gender, race, baseline HbA1c, baseline visual acuity) in each study were generally consistent with the results in the overall population.

Figure 3 Figure 4

Macular Edema Following Retinal Vein Occlusion (RVO)

The safety and efficacy of VABYSMO were assessed in two randomized, multicenter, double-masked, studies (BALATON – NCT04740905 in patients with macular edema following branch retinal vein occlusion, and COMINO – NCT04740931 in patients with macular edema following central retinal vein occlusion/hemiretinal vein occlusion). Active comparator-controlled data are available through month 6. A total of 1,282 newly diagnosed, treatment-naïve patients were enrolled in these studies, of which 641 patients received at least one dose of VABYSMO through 6 months.

In both studies, the VABYSMO 6 mg Q4W arm demonstrated non-inferiority to the comparator control (aflibercept) arm for the primary endpoint, which was defined as the change from baseline in BCVA at week 24, measured by the ETDRS Letter Score. Detailed results for both BALATON and COMINO studies are shown in Table 4, Figure 5, and Figure 6 below.

Table 2: Primary Endpoint Results Average of weeks 40, 44 and 48 in the TENAYA and LUCERNE Studies
	TENAYA		LUCERNE
	VABYSMO N = 334	Aflibercept N = 337	VABYSMO N = 331	Aflibercept N = 327
BCVA: Best Corrected Visual Acuity
ETDRS: Early Treatment Diabetic Retinopathy Study
CI: Confidence Interval
LS: Least Square
Mean change in BCVA as measured by ETDRS letter score from baseline (95% CI)	5.8 (4.6, 7.1)	5.1 (3.9, 6.4)	6.6 (5.3, 7.8)	6.6 (5.3, 7.8)
Difference in LS mean (95% CI)	0.7 (-1.1, 2.5)		0.0 (-1.7, 1.8)

Table 4: Primary Endpoint Results at Week 24 in the BALATON and COMINO Studies
	BALATON		COMINO
	VABYSMO N = 276	Aflibercept N = 277	VABYSMO N = 366	Aflibercept N = 363
BCVA: Best Corrected Visual Acuity
ETDRS: Early Treatment Diabetic Retinopathy Study
CI: Confidence Interval
LS: Least Square
Mean change in BCVA as measured by ETDRS letter score from baseline (95% CI)	16.9 (15.7, 18.1)	17.5 (16.3, 18.6)	16.9 (15.4, 18.3)	17.3 (15.9, 18.8)
Difference in LS mean (95% CI)	-0.6 (-2.2, 1.1)		-0.4 (-2.5, 1.6)

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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