ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% Important Information
INDICATIONS AND USAGE
ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%
is an alpha-adrenergic receptor agonist indicated for the reduction of elevated
intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Neonates and Infants (under the age of 2 years): ALPHAGAN®
P is contraindicated in neonates and infants (under the age of 2 years).
Hypersensitivity Reactions: ALPHAGAN® P is contraindicated
in patients who have exhibited a hypersensitivity reaction to any component of this
medication in the past.
WARNINGS AND PRECAUTIONS
Potentiation of Vascular Insufficiency: ALPHAGAN®
P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN®
P should be used with caution in patients with depression, cerebral or coronary
insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis
obliterans.
Severe Cardiovascular Disease: Although brimonidine tartrate ophthalmic
solution had minimal effect on the blood pressure of patients in clinical studies,
caution should be exercised in treating patients with severe cardiovascular disease.
Contamination of Topical Ophthalmic Products After Use: There have
been reports of bacterial keratitis associated with the use of multiple-dose containers
of topical ophthalmic products. These containers had been inadvertently contaminated
by patients who, in most cases, had a concurrent corneal disease or a disruption
of the ocular epithelial surface.
DRUG INTERACTIONS
Antihypertensives/Cardiac Glycosides: Because ALPHAGAN®
P may reduce blood pressure, caution in using drugs such as antihypertensives and/or
cardiac glycosides with ALPHAGAN® P is advised.
CNS Depressants: Although specific drug interaction studies have
not been conducted with ALPHAGAN® P, the possibility of an additive
or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives,
or anesthetics) should be considered.
Tricyclic Antidepressants: Tricyclic antidepressants have been
reported to blunt the hypotensive effect of systemic clonidine. It is not known
whether the concurrent use of these agents with ALPHAGAN® P in humans
can lead to resulting interference with the IOP-lowering effect. Caution is advised
in patients taking tricyclic antidepressants, which can affect the metabolism and
uptake of circulating amines.
Monoamine Oxidase Inhibitors: Monoamine oxidase (MAO) inhibitors
may theoretically interfere with the metabolism of brimonidine and potentially result
in an increased systemic side effect such as hypotension. Caution is advised in
patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating
amines.
ADVERSE REACTIONS
Adverse reactions occurring in approximately 10% to 20% of the subjects receiving
brimonidine ophthalmic solution (0.1% to 0.2%) included: allergic conjunctivitis,
conjunctival hyperemia, and eye pruritus. Adverse reactions occurring in approximately
5% to 9% included: burning sensation, conjunctival folliculosis, hypertension, ocular
allergic reaction, oral dryness, and visual disturbance.
Please click here for the full Prescribing Information for ALPHAGAN®
P.
COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% Important Information
INDICATIONS AND USAGE
COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist
with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with
glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the
IOP-lowering of COMBIGAN® dosed twice a day was slightly less than that seen with the concomitant administration
of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed
three times per day.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
COMBIGAN® is contraindicated in patients with reactive airway disease including bronchial asthma; a history of
bronchial asthma; severe chronic obstructive pulmonary disease; in patients with sinus bradycardia; second or third degree
atrioventricular block; overt cardiac failure; in neonates and infants (aged 2 years and younger); in
patients with a hypersensitivity reaction to any component of COMBIGAN® in the past.
WARNINGS AND PRECAUTIONS
COMBIGAN® contains timolol maleate. COMBIGAN® is administered topically, but can be absorbed systemically.
The adverse reactions with systemic administration of beta-adrenergic blocking agents may occur with topical use (eg, severe
respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in
association with cardiac failure, have been reported with systemic or ophthalmic administration of timolol maleate). Ophthalmic
beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
Sympathetic stimulation may be essential to support the circulation in patients with diminished myocardial contractility,
and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In patients with no history
of cardiac failure, continued depression of the myocardium with beta-blocking agents over time can lead to cardiac failure.
Discontinue COMBIGAN® at the first sign or symptom of cardiac failure.
Patients with chronic obstructive pulmonary disease (eg, chronic bronchitis, emphysema) of mild or moderate severity,
bronchospastic disease, or a history of bronchospastic disease should not receive beta-blocking agents, including
COMBIGAN®.
COMBIGAN® may potentiate syndromes associated with vascular insufficiency. Use caution in patients with depression,
cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Patients taking beta-blockers with a history of atopy or severe anaphylactic reactions to a variety of allergens may be
more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be
unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
Beta-adrenergic blockade can potentiate muscle weakness with myasthenic symptoms (eg, diplopia, ptosis, and generalized
weakness). Although rare, timolol can increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia and clinical signs (eg,
tachycardia) of hyperthyroidism. Use caution in patients subject to spontaneous hypoglycemia or in diabetic patients
(especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Carefully manage patients
who may develop thyrotoxicosis to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid
storm.
Ocular hypersensitivity has occurred with brimonidine tartrate ophthalmic solutions 0.2% (eg, increase in IOP).
Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents due to impairment of
beta-adrenergically mediated reflexes during surgery. If necessary during surgery, the effects of beta-adrenergic blocking
agents may be reversed by sufficient doses of adrenergic agonists.
ADVERSE REACTIONS
The most frequent reactions with COMBIGAN® in about 5% to 15% of patients included: allergic conjunctivitis,
conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.
DRUG INTERACTIONS
COMBIGAN® may reduce blood pressure. Use caution in patients on antihypertensives and/or cardiac glycosides.
Observe patients receiving a beta-adrenergic blocking agent either orally or intravenously and COMBIGAN® for
additive effects of beta-blockade, both systemic and on intraocular pressure. Concomitant use of two topical beta-adrenergic
blocking agents is not recommended.
Use caution in the co-administration of beta-adrenergic blocking agents (eg, COMBIGAN®) and oral or intravenous
calcium antagonists due to possible atrioventricular conduction disturbances, left ventricular failure, and hypotension.
Avoid co-administration in patients with impaired cardiac function.
Observe patients closely when a beta-blocker is administered to patients receiving catecholamine-depleting drugs
(eg, reserpine) due to possible additive effects and the production of hypotension and/or marked bradycardia, which may
result in vertigo, syncope, or postural hypotension.
Specific drug interaction studies have not been conducted with COMBlGAN®, but consider the possibility of an
additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics).
Concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in
prolonging atrioventricular conduction time.
Potentiated systemic beta-blockade (eg, decreased heart rate, depression) has been reported with combined use of CYP2D6
inhibitors (eg, quinidine, SSRls) and timolol.
Tricyclic antidepressants (TCAs) can blunt the hypotensive effect of systemic clonidine. It is not known whether the
concurrent use of TCAs with COMBIGAN® in humans can interfere with the IOP-lowering effect. Caution is advised in
patients taking TCAs, which can affect the metabolism and uptake of circulating amines.
Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially increase
systemic side effects such as hypotension. Use caution in patients taking MAO inhibitors, which can affect the metabolism
and uptake of circulating amines.
Please click here for full Prescribing Information.
LASTACAFT® (alcaftadine ophthalmic solution) 0.25% Important Information
INDICATIONS AND USAGE
LASTACAFT® (alcaftadine ophthalmic solution) 0.25% is an H1
histamine receptor antagonist indicated for the prevention of itching associated
with allergic conjunctivitis.
MECHANISM OF ACTION
Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the
release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil
activation have also been demonstrated.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
To minimize contaminating the dropper tip and solution, care should be taken not
to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep
bottle tightly closed when not in use.
Patients should be advised not to wear a contact lens if their eye is red.
LASTACAFT® should not be used to treat contact lens-related irritation.
Remove contact lenses prior to instillation of LASTACAFT®. The preservative
in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact
lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT®.
LASTACAFT® is for topical ophthalmic use only.
ADVERSE REACTIONS
The most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT®
treated eyes, were eye irritation, burning and/or stinging upon instillation, eye
redness, and eye pruritus.
The most frequent non-ocular adverse reactions, occurring in < 3% of subjects
with LASTACAFT® treated eyes, were nasopharyngitis, headache, and
influenza. Some of these events were similar to the underlying disease being studied.
Please click here for the full Prescribing Information for LASTACAFT®.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
Indication
LATISSE® (bimatoprost ophthalmic solution) 0.03%
is indicated to treat hypotrichosis of the eyelashes by increasing their growth,
including length, thickness, and darkness.
Important Safety Information
Contraindications: LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.
Warnings and Precautions: In patients using LUMIGAN®
(bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment
of elevated intraocular pressure (IOP), the concomitant use of LATISSE®
may interfere with the desired reduction in IOP. Patients using prostaglandin analogs
including LUMIGAN® for IOP reduction should only
use LATISSE® after consulting with their physician
and should be monitored for changes to their intraocular pressure.
Increased iris pigmentation has occurred when bimatoprost solution was administered.
Patients should be advised about the potential for increased brown iris pigmentation,
which is likely to be permanent.
Bimatoprost has been reported to cause pigment changes (darkening) to periorbital
pigmented tissues and eyelashes. The pigmentation is expected to increase as long
as bimatoprost is administered, but has been reported to be reversible upon discontinuation
of bimatoprost in most patients.
There is the potential for hair growth to occur in areas where LATISSE®
solution comes in repeated contact with skin surfaces. Apply LATISSE®
only to the skin of the upper eyelid margin at the base of the eyelashes.
LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated. LATISSE® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Adverse Reactions: The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.
Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.
Please click here for full Prescribing Information for LATISSE®.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Important Information
INDICATION
LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
LUMIGAN® 0.01% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.
WARNINGS AND PRECAUTIONS
Pigmentation
Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term
effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. While treatment with LUMIGAN® 0.01% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
Eyelash Changes
LUMIGAN® 0.01% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation
Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis).
Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Use with Contact Lenses
LUMIGAN® 0.01% contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to instillation of LUMIGAN® 0.01% and may be reinserted 15 minutes following its administration.
ADVERSE REACTIONS
In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug reactions (reported in 1 to 4% of patients) with LUMIGAN® 0.01% in this study included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye
pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, and visual acuity reduced.
USE IN SPECIFIC POPULATIONS
Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended because of potential safety
concerns related to increased pigmentation following long-term chronic use.
Please click here for the full Prescribing Information for LUMIGAN®.
OZURDEX® (dexamethasone intravitreal implant) 0.7 mg Important Information
Indications and Usage
Diabetic Macular Edema
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment
of diabetic macular edema.
Retinal Vein Occlusion
OZURDEX® is a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.
Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out under controlled aseptic conditions.
Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis.
Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
IMPORTANT SAFETY INFORMATION
Contraindications
Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in
patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva,
including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal
diseases.
Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater
than 0.8.
Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens
capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic
patients is not a contraindication for OZURDEX® use.
Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components
of this product.
Warnings and Precautions
Intravitreal Injection‐related Effects: Intravitreal injections, including those with OZURDEX®, have been associated
with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly
following the injection.
Steroid‐related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts,
increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or
viruses.
Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for
reactivation of the viral infection.
Adverse Reactions
Diabetic Macular Edema:
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following
injection of OZURDEX® for diabetic macular edema include: cataract (68%), conjunctival hemorrhage (23%), visual acuity
reduced (9%), conjunctivitis (6%), vitreous floaters (5%), conjunctival edema (5%), dry eye (5%), vitreous detachment (4%), vitreous
opacities (3%), retinal aneurysm (3%), foreign body sensation (2%), corneal erosion (2%), keratitis (2%), anterior chamber inflammation
(2%), retinal tear (2%), eyelid ptosis (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include:
hypertension (13%) and bronchitis (5%).
Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 28% of
OZURDEX® patients versus 4% of sham patients. 42% of the patients who received OZURDEX® were subsequently
treated with IOP-lowering medications during the study versus 10% of sham patients.
The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles
(at the end of the 6-month period).
Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was
higher in the OZURDEX® group (68%) compared with Sham (21%). The median time of cataract being reported as an adverse event was
approximately 15 months in the OZURDEX® group and 12 months in the Sham group. Among these patients, 61% of OZURDEX® subjects
versus 8% of sham-controlled subjects underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for
OZURDEX® group and 20 for Sham) of the studies.
Retinal Vein Occlusion and Posterior Segment Uveitis:
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.
Please click here for full Prescribing Information for OZURDEX®.
RESTASIS® and RESTASIS MultiDose® Important Information
Indications and Usage
RESTASIS® and RESTASIS MultiDose® ophthalmic emulsion are indicated to increase tear production in patients whose tear production is presumed to be suppressed due to
ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently
taking topical anti-inflammatory drugs or using punctal plugs.
Important Safety Information
Contraindications
RESTASIS® and RESTASIS MultiDose® are contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
Warnings and Precautions
Potential for Eye Injury and Contamination: Be careful not to touch the container tip to your eye or other surfaces to avoid potential for eye injury and contamination.
Use With Contact Lenses: RESTASIS® and RESTASIS MultiDose® should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS® and RESTASIS MultiDose® ophthalmic emulsion.
Adverse Reactions
Diabetic Macular Edema
clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion 0.05% was ocular burning (upon instillation)—17%. Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
Please click here for full Product Information for RESTASIS® and RESTASIS MULTIDOSE®.
TRUETEAR® Important Information
INDICATION
TrueTear® provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not prescribe TrueTear® to patients with a cardiac demand pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device within head or neck; a known hypersensitivity to the hydrogel device material; or chronic or recurrent nosebleeds, or bleeding disorder/condition that can lead to increased bleeding.
WARNINGS
Do not apply stimulation around electronic monitoring equipment (eg, cardiac monitors, ECG alarms), in the bath/shower,
while driving, operating machinery, during activity in which sneezing/watery eyes may cause risk, areas other than the nose,
within 3 feet of shortwave or microwave therapy equipment, around flammable anesthetics mixture (air, oxygen or nitrous oxide).
Persistent use on irritated nasal tissue may cause injury. The device is limited only to the improvement in dry eye symptoms,
as the safety and effectiveness for neither the treatment of dry eye disease nor use for periods longer than 6 months has been
established. Safety not established in pregnancy, patients under 22 years of age, patients with nasal or sinus surgery
(including nasal cautery) or significant trauma; severe nasal airway obstruction or vascularized polyp; active, severe
systemic or chronic seasonal allergies; rhinitis or sinusitis requiring treatment; untreated nasal infection; and disabling
arthritis, neuropathy, severe dexterity impairment or limited motor coordination. Use only manufacturer’s supplied accessories.
PRECAUTIONS
Consult patients to discontinue use if pain, discomfort or numbness in the nose persists after adjusting for high
levels/long sessions; to remove studs, nose rings, or other nose jewelry before use; to not use prescription eye medications
or nasal sprays 30 minutes before or after using TrueTear®. Suspected or diagnosed heart disease patients should follow
doctor’s precautions. Keep away from children. Clean as directed. Failure to replace the tip as directed will cause the
device to not work properly.
ADVERSE EVENTS
Nasal pain, discomfort or burning (10.3%); transient electrical discomfort (5.2%); nosebleed (5.2%); nasal congestion (3.1%);
headaches (2.1%); trace blood, dot heme in nostril (2.1%); facial pain (2.1%); sore eye (1.0%); sinus pain (1.0%); periorbital
pain (1.0%); runny nose (1.0%); nasal ulcers (1.0%); and light-headedness (1.0%).
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Proper patient training on
use of the device is required before home use. For the full Directions for Use, please visit
www.allergan.com/truetear/usa.htm or call 1-800-678-1605.
Please call 1-800-433-8871 to report an adverse event.
XEN® Gel Stent Important Information
INDICATIONS
The XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector) is
indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed,
cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive
to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XEN® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened,
previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active
iris neovascularization, anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.
WARNINGS
XEN® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant
exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and
effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following
implantation of the XEN® Gel Stent to avoid the potential for implant damage.
PRECAUTIONS
Examine the XEN® Gel Stent and XEN® Injector in the operating room prior to use. Monitor
intraocular pressure (IOP) postoperatively and if not adequately maintained, manage appropriately. Stop the procedure
immediately if increased resistance is observed during implantation and use a new XEN® system. Safety
and effectiveness of more than a single implanted XEN® Gel Stent has not been studied.
ADVERSE EVENTS
The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%;
> 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were
associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from
baseline (21.5%), and needling procedure (32.3%).
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Please
click here
for the full Directions for Use. Please call 1-800-433-8871 to report an adverse event.