Bridgewater, NJ – May 6, 2013 – Valeant Ophthalmics, a division of Valeant Pharmaceuticals North America LLC, now provides four established therapies designed to meet the needs of specific patient populations in dry eye, glaucoma and wet age-related macular degeneration.
Valeant Ophthalmics products currently include LACRISERT® (hydroxypropyl cellulose ophthalmic insert) for moderate to severe Dry Eye Syndromes; TIMOPTIC® (timolol maleate 0.5% ophthalmic solution) in OCUDOSE® (dispenser), a classic intraocular pressure (IOP) lowering medication available in a preservative-free form; MACUGEN® (pegaptanib sodium injection), approved to treat wet age-related macular degeneration (AMD); and VISUDYNE® (verteporfin for injection), used to treat abnormal growth of leaky blood vessels in the eye caused by wet age-related macular degeneration.
“Our four brands represent major areas of eye disease, providing ophthalmic therapies matched to individual patient needs,” explained Tage Ramakrishna, M.D., Chief Medical Officer of Valeant Pharmaceuticals International, Inc. “Our products support clinicians in refining ophthalmic therapies to provide an individualized approach in patient management for patient satisfaction.”
For example, TIMOPTIC in OCUDOSE provides glaucoma patients who are affected by preservative toxicity with a preservative-free option for lowering their IOP. LACRISERT delivers dry eye therapy in a formulation that can provide ongoing protection through the course of a day.
“Valeant Ophthalmics is part of a growing pharmaceutical company that will be able to bring greater resources than ever before and is committed to supporting ophthalmics,” added Dr. Ramakrishna.
Valeant Ophthalmics was created in 2010 through Valeant Pharmaceuticals’ acquisition of Aton Pharma, Inc., a specialty pharmaceutical company focused on ophthalmology and certain orphan drug indications. Aton’s products included LACRISERT and TIMOPTIC in OCUDOSE. Valeant added MACUGEN to its ophthalmic franchise through its acquisition in February 2012 of Eyetech Inc., a privately-owned ophthalmic biotechnology company dedicated to the treatment of sight-threatening diseases of the retina. The company acquired VISUDYNE® from QLT Inc. in September 2012.
Indications for LACRISERT
LACRISERT (hydroxypropyl cellulose ophthalmic insert) is indicated in patients with moderate to severe Dry Eye Syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with exposure keratitis, decreased corneal sensitivity and recurrent corneal erosions.
Important Safety Information About LACRISERT
LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose. Instructions for inserting and removing LACRISERT should be carefully followed. If improperly placed, LACRISERT may result in corneal abrasion. Because LACRISERT may cause transient blurred vision, patients should be instructed to exercise caution when driving or operating machinery. Patients should be cautioned against rubbing the eye(s) containing LACRISERT.
The most commonly reported adverse events were transient blurring of vision, ocular discomfort or irritation, matting or stickiness of eyelashes, photophobia, hypersensitivity, eyelid edema, and hyperemia.
Indications for TIMOPTIC in OCUDOSE
Preservative-free TIMOPTIC (timolol maleate 0.5% ophthalmic solution) in OCUDOSE (dispenser) is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free TIMOPTIC in OCUDOSE may be used when a patient is sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
Important Safety Information About TIMOPTIC in OCUDOSE
Timoptic is contraindicated in patients with: bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any component of this product.
This drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. Severe respiratory or cardiac reactions, including death, have been reported following systemic or ophthalmic administration of timolol maleate. TIMOPTIC should be used with caution in patients with cerebrovascular insufficiency. The most frequently reported adverse experiences have been burning and stinging upon instillation.
Indications for MACUGEN
MACUGEN (pegaptanib sodium injection) is approved to treat wet age-related macular degeneration. It is available by prescription only. Not all people respond the same to MACUGEN, so individual results may vary. The safety or efficacy of MACUGEN has not been proven beyond 2 years.
Important Safety Information About MACUGEN
With MACUGEN, you may have some side effects, mostly in the eye and due to the injection procedure. The most common side effects are burning sensation, eye pain, redness, light sensitivity, vision loss, blurred vision, visual disturbances, high blood pressure, and cataract. For a complete list of side effects, please ask your doctor or see the prescribing information.
You should not receive MACUGEN if you have an infection in or around your eye or if you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients. A serious eye infection can sometimes develop after an injection into the eye. Signs of a serious infection may include eye pain, light sensitivity, and/or vision changes. Check with a retinal physician immediately if you experience any of these symptoms, so you can be treated early if an infection occurs.
Eye injections like those with MACUGEN can increase eye pressure. This is something you would not notice; however, your retinal physician may do some extra tests after your injection to make sure there are no complications. In rare cases, allergic reactions have been known to occur. Tell your retinal physician about any known allergies.
You are encouraged to report side effects of prescription drugs to the FDA.
Indications for VISUDYNE
VISUDYNE (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE® for the treatment of predominantly occult subfoveal choroidal neovascularization.
Important Safety Information About VISUDYNE
VISUDYNE therapy is not for everyone. People who have an abnormal sensitivity to light (a condition called porphyria) and those with allergies to any of the ingredients should not receive VISUDYNE. (Your doctor has a list of ingredients in VISUDYNE.) Check with your doctor or healthcare professional to see if you might be allergic to any component of VISUDYNE therapy. Only your doctor can determine if VISUDYNE is right for you.
Between 1% and 5% of patients experienced a substantial decrease in vision in the first 7 days after treatment, though some patients achieved partial recovery. Patients who experience substantial vision loss should consult their ophthalmologist or retinal specialist immediately. The most commonly reported adverse events (10-30%) were injection site reactions, temporary back pain during injection, changes in vision, including blurring, decreased sharpness in vision, and gaps in vision.
Patients should avoid direct sunlight or bright indoor light for 5 days following therapy with VISUDYNE. Patients who have to go outdoors in daylight after treatment must protect all parts of their skin and eyes by wearing protective clothing and dark glasses. Ultraviolet (UV) sunscreens are not effective in protecting against photosensitivity reactions.
About Valeant Ophthalmics
Valeant Ophthalmics, a division of Valeant Pharmaceuticals North America LLC, is part of a growing pharmaceutical company that is committed to supporting ophthalmics. Valeant Ophthalmics provides clinicians with established therapies that are designed to meet the needs of specific patient populations. Our “Art and Science of Vision” theme reflects the company’s commitment to refining ophthalmic therapies to better match treatments to individual patient needs and to support eye care professionals in the art of patient management.