Harrow Health Announces Launch of IOPIDINE® 1% and MAXITROL® in the United States
“We are pleased to have completed the transfer of the NDAs for these workhorse products, allowing us to market and sell these well-known products under the Harrow umbrella,” said
Product orders for IOPIDINE 1% and
About IOPIDINE® (apraclonidine hydrochloride ophthalmic solution) 1%
IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha-adrenergic agonist, in a sterile isotonic solution for topical application to the eye.
INDICATIONS AND USAGE
IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in intraocular pressure (IOP) that occur in patients after argon laser trabeculoplasty, argon laser iridotomy, or Nd:YAG posterior capsulotomy.
IOPIDINE 1% Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine.
FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral ingestion.
Patients who develop exaggerated reductions in IOP should be closely monitored. Caution should be observed in treating patients with severe cardiovascular disease including hypertension. IOPIDINE 1% Ophthalmic Solution should also be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, chronic renal failure, Raynaud’s disease, or thromboangiitis obliterans.
The possibility of a vasovagal attack occurring during laser surgery should be considered and caution used in patients with a history of such episodes.
Information for Patients
Apraclonidine can cause dizziness and somnolence. Patients who engage in hazardous activities requiring mental alertness should be warned of the potential for a decrease in mental alertness on the day of surgery.
The following adverse events, occurring in less than 2% of patients, were reported in association with the use of IOPIDINE 1% Ophthalmic Solution in laser surgery: ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis.
About MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) 3.5mg/10,000 units/0.1%
MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.
MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
NOT FOR INJECTION. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. IOP should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
MAXITROL® is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye. Products containing neomycin sulfate may cause cutaneous sensitization. Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. The severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during the use of the product, treatment should be discontinued. Cross‑hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
The initial prescription and renewal of the medication order beyond 20 mL of MAXITROL® should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be reevaluated.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. Prolonged use of topical anti-bacterial agents may give rise to overgrowth of non-susceptible organisms including fungi.
Information for Patients
If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue the use of the medication and consult a physician.
This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep the bottle tightly closed when not in use. Keep out of reach of children.
Patients should be advised that their vision may be temporarily blurred following dosing with MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension). Care should be exercised in operating machinery or driving a motor vehicle.
The reactions due to the corticosteroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids.
Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome.
The following additional adverse reactions have been reported with dexamethasone use: Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.
About MOXEZA® (moxifloxacin ophthalmic solution) 0.5%
MOXEZA® (moxifloxacin ophthalmic solution) is a sterile solution for topical ophthalmic use.
INDICATIONS AND USAGE
MOXEZA is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis.*
*Efficacy for this organism was studied in fewer than 10 infections.
WARNINGS AND PRECAUTIONS
Corneal Endothelial Damage and Toxic Anterior Segment Syndrome
NOT FOR INTRACAMERAL USE OR INJECTION. MOXEZA will cause damage to the corneal endothelium if introduced directly into the anterior chamber of the eye.
Toxic Anterior Segment Syndrome (TASS) has been reported following intraocular administration of moxifloxacin. TASS is typically characterized by anterior chamber inflammatory reactions, such as fibrin, cell or flare and corneal edema, but other events, such as hypopyon, keratic precipitates or vitreous opacities may also occur.
In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Growth of Resistant Organisms With Prolonged Use
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit‑lamp biomicroscopy, and, where appropriate, fluorescein staining.
Avoidance of Contact Lens Wear
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Information for Patients
Avoid Contamination of the Product
Advise patients not to touch the dropper tip to any surface to avoid contaminating the contents.
Avoid Contact Lens Wear
Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Systemically administered quinolones, including moxifloxacin, have been associated with hypersensitivity reactions, even following a single dose. Advise patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction [see Warnings and Precautions].
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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to MOXEZA in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1% to 2% of patients.
This press release contains “forward-looking statements” within the meaning of the
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