Alcon announced the FDA approval of Simbrinza Suspension, a new beta-blocker-free, fixed-combination therapy for patients with glaucoma.
The FDA has approved Bausch & Lomb's New Drug Application for Prolensa ophthalmic solution, which treats post-operative inflammation and reduces ocular pain in patients who have undergone cataract surgery. Bromfenac is a non-steroidal anti-inflammatory drug.
pSivida Corporation licensee Alimera Sciences has resubmitted its NDA in response to a second Complete Response Letter issued from the FDA for Iluvien, a possible treatment for chronic diabetic macular edema.
After reports surfaced of five intraocular infections at a physician's office, Clinical Specialties is undertaking a voluntary recall of Avastin unit dose syringes. The sterile syringes were being used solely for an off-label indication by an ophthalmologist for macular degeneration.
Bausch & Lomb has released Lotemax Gel 0.5%, a corticosteroid for the treatment of post-operative inflammation and pain following ocular surgery. Lotemax Gel 0.5% is sold as a 5g fill in a 10mL bottle; Ointment 0.5% and Suspension 0.5% are also available.
During its recently completed Phase 3 clinical trial of BromSite, InSite Vision achieved top-line results for the reduction of inflammation and pain after cataract surgery. BromSite is a combination of low dose (0.075%) bromfenac, a NSAID, and the company's DuraSite drug delivery technology.
Cytomegalovirus-associated posterior uveitis or panuveitis can develop in patients without HIV infection, most of whom have evidence of compromised immune function.
For pediatric patients undergoing hematopoietic stem cell transplantation (HSCT), complications are common, but are generally mild and self-limiting.
The American Academy of Ophthalmology (AAO) is participating in the Choosing Wisely campaign and has identified five tests and treatments that may be overused.
Sucampo announced that Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is now available.
The U.S. Preventive Services Task Force has reviewed the comparative evidence of medical, laser, and surgical treatments to inform their recommendations on screening for open-angle glaucoma.
Mobius Therapeutics announced that it is conducting a voluntary recall of two lots of Mitosol (mitomycin for solution), 0.2mg/vial Kit for Ophthalmic Use due to the possibility that the affected lots may be non-sterile.
The prevalence of open-angle glaucoma has increased more than 20% in the last 10 years and currently affects more than 2.7 million Americans aged ≥40 years.
Sucampo announced that it has received approval of an sNDA for Rescula (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
For patients with mild-to-moderate open-angle glaucoma, implantation of a nickel titanium microstent (Hydrus Microstent) is associated with significant reduction in intraocular pressure, which is maintained at one year.
Omeros reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.
The FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter (OTC) eye drops used to relieve redness and nasal decongestant sprays can result in serious and fatal adverse events.
SARcode Bioscience announced topline results from OPUS-1, a pivotal Phase 3 study of lifitegrast ophthalmic solution, 5%, vs. placebo for the treatment of dry eye disease.
The FDA has approved Jetrea (ocriplasmin; ThromboGeneics) for the treatment of symptomatic vitreomacular adhesion (VMA), a progressive sight threatening condition.
For patients undergoing radical prostatectomy, perioperative visual injury (POVI) increased from 2000-2009, with significantly increased rates for robotic-assisted vs. an open approach procedure.
Long-term aggressive treatment of patients with macular edema with ranibizumab during a third year correlates with reduced mean foveal thickness (FTH) and improved best-corrected visual acuity (BCVA).
There is a positive association between heavy coffee consumption and risk of exfoliation glaucoma or exfoliation glaucoma suspect (EG/EGS).
Regeneron announced that the FDA has approved Eylea (aflibercept injection) for the treatment of macular edema following central retinal vein occlusion (CRVO).
The Berkeley Rudimentary Vision Test (BRVT), a simplified visual task, is feasible for measuring visual acuity in patients with severe visual impairment.
ThromboGenics announced data from two Phase 3 clinical trials evaluating ocriplasmin for the treatment of vitreomacular traction (VMT) and macular holes.
A contact lens sensor (CLS) provides safe and tolerable 24-hour monitoring of intraocular pressure (IOP) patterns in patients with or suspected of having glaucoma.
Statin use, which is substantially higher in patients with type 2 diabetes, correlates with an increased risk of age-related (AR) cataracts.
Genentech announced that the FDA has approved Lucentis (ranibizumab injection 10mg/mL) for the treatment of diabetic macular edema (DME).
For patients with hepatitis C virus (HCV) treated with pegylated interferon alpha (PegIFNα) and ribavirin, retinopathy occurs frequently, especially in those with hypertension.
Elderly patients with cataract who receive cataract surgery have a reduced likelihood of subsequent hip fracture, compared with those who do not undergo surgery.
Increasing time spent outdoors may reduce the development or progression of myopia in children and adolescents.
ThromboGenics announced that the FDA has accepted for filing its Biologics License Application (BLA) for ocriplasmin intravitreal injection 2.5mg/mL and granted it priority review for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.
Over the past several decades there has been a significant decrease in the prevalence of self-reported visual impairment among older adults in the United States.
In patients with diabetes, with or without diabetic retinopathy, serum apolipoproteins (apos) are associated with markers of systemic and retinal microvascular dysfunction.
An ocular stent that's designed to reduce inner-eye pressure among people with mild or moderate open-angle glaucoma has been approved by the US Food and Drug Administration.
An eye test measuring ocular pulse amplitude (OPA) can be performed by ophthalmologists to detect severe carotid artery stenosis (CAS), a known risk factor for stroke.
For non-adherent patients with glaucoma, adherence measures are significantly improved for those assigned to an interactive, telephone-based communication intervention or usual care.
Cerebral damage and retinopathy of prematurity (ROP) are both independent risk factors for visual impairment in preschool children who were born extremely premature, with cerebral damage being the primary risk factor.
Cosopt PF (dorzolamide HCl 2%, timolol maleate 0.5% ophthalmic solution), the preservative-free formulation of Cosopt (contains benzalkonium chloride) has been made available by Merck.
Fera Pharmaceuticals announced that Methazolamide (marketed as Neptazane) tablets will commence shipping June 1, 2012.
The FDA is notifying all physicians and healthcare organizations of the recall of all sterile products sold by Franck's Compounding Pharmacy since November 2011 due to the possibility of lack of sterility.
Avastin (bevacizumab) and Lucentis (ranibizumab) have similar effects on visual acuity in age-related macular degeneration (AMD).
Franck's Compounding Pharmacy has recalled one additional lot of triamcinolone acetonide PF 80mg/mL.
Two genomic regions have been identified that are associated with normal-pressure glaucoma (NPG) and optic nerve disease in exfoliation-syndrome glaucoma (ESG), possibly through the transforming growth factor beta (TGF-beta) signaling pathway.
Staphylococcus aureus (S. aureus) and S. aureus-secreted enterotoxins (SE) are frequently found in patients with atopic keratoconjunctivitis (AKC), particularly in those with corneal ulceration.
The FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012.
ThromboGenics announced that it has resubmitted a Biologics License Application (BLA) with the FDA for ocriplasmin intravitreal injection 2.5mg/mL for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
Intravitreally administered injections of the selective vascular endothelial growth factor (VEGF)-165 inhibitor pegaptanib significantly reduces foveal thickness and improves visual acuity in patients with diabetes and macular edema.
At two years of follow-up, diabetes-related clinically significant macular edema (CSME) is more effectively improved by intravitreous bevacizumab than with macular laser therapy (MLT).
Omeros announced that patient enrollment has begun for its second Phase 3 trial for OMS302 in intraocular lens replacement (ILR) surgery.
MacuCLEAR, Inc. announced that it is beginning Phase 3 studies for MC-1101 for early-stage age-related macular degeneration (AMD).
Ocular tremors, which prevent eye stability while fixating on a target, are pervasive among patients with Parkinson's disease.
First-time users of oral bisphosphonates have an increased risk of both uveitis and scleritis compared with nonusers.
The FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries.
The presence of retinopathy in older women is associated with cognitive decline and greater ischemic brain volumes.
Although the overall impact of routine glaucoma screening of middle-aged African-Americans may be modest, it would likely reduce the lifetime prevalence of glaucoma and glaucoma-related visual impairment and blindness.
Omeros reported positive data from its Phase 3 clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery.
Avedro announced that it has submitted a New Drug Application (NDA) to the FDA for VibeX (riboflavin ophthalmic solution)/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery.
Although significantly increased in subjects with new diabetes, the rates of typical diabetic polyneuropathy (DPN), retinopathy, and nephropathy are not significantly different between subjects with and without impaired glycemia (IG).
Men with erectile dysfunction (ED) are almost three times more likely to have been previously diagnosed with glaucoma.
Generic topical prostaglandin analogs (PGAs) and treatment with laser trabeculoplasty (LTP) are both cost-effective for treatment of newly diagnosed mild open-angle glaucoma, with PGAs providing better quality of life relative to LTP.
Merck announced that the FDA has approved Zioptan (tafluprost ophthalmic solution) 0.0015%, a preservative-free prostaglandin analog ophthalmic solution, for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension.
For patients with a hereditary form of blindness previously treated with gene therapy in one eye, a second dose of gene therapy in the other eye is safe and improves vision even further.
Frequent use of aspirin in patients ≥65 years is associated with early aging macular disorder (AMD) and wet late AMD.
ThromboGenics announced that is has submitted a Biologics License Application (BLA) to the FDA for ocriplasmin intravitreal injection 2.5mg/mL for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
Avedro announced that the FDA has granted a second orphan drug designation for VibeX (riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for corneal cross-linking to treat corneal ectasia following refractive surgery, such as Lasik and photorefractive keratectomy.
Santen announced that the FDA has granted orphan drug designation for sirolimus (DE-109) for the treatment of chronic/refractory anterior non-infectious uveitis, non-infectious intermediate uveitis, non-infectious panuveitis, and non-infectious uveitis affecting the posterior segment of the eye.
Clermont Pharmaceuticals announced positive results from its Phase 3 study of non-preserved latanoprost for the treatment of glaucoma.
The FDA is alerting healthcare professionals that repackaged intravitreal injections of Avastin (bevacizumab; Genentech) have caused a cluster of serious eye infections in the Miami area.
ThromboGenics NV announced new data from its pivotal ocriplasmin Phase 3 program including six month outcomes for the treatment of symptomatic vitreomacular adhesion (VMA) including macular holes.
Fera Pharmaceuticals announced that it has launched four ophthalmic ointments: Neo-Polycin (neomycin and polymyxin B sulfates and bacitracin zinc), Neo-Polycin HC (neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone acetate), Polycin (bacitracin zinc and polymyxin B sulfates), and neomycin and polymyxin B sulfates with dexamethasone.
pSivida Corp. announced new data from its Phase 3 study of Iluvien (sustained release fluocinolone acetonide insert) for the treatment of diabetic macular edema.
OCuSOFT has made available the Ocudox Convenience Kit for the treatment of acute eyelid disease.
Regeneron and Bayer HealthCare announced positive results from their Phase 3 GALILEO study of VEGF Trap-Eye (aflibercept ophthalmic solution) for the treatment of patients with macular edema due to central retinal vein occlusion.
Omeros announced positive results from its Phase 2b study of OMS302 for the maintenance of mydriasis and reduction of postoperative ocular pain in patients undergoing cataract surgery.
InSite Vision announced results from its Phase 1/2 study of ISV-303 for the reduction of pain and inflammation associated with ocular surgery.
Allergan has made available Lastacaft (alcaftadine ophthalmic solution), an H1 histamine receptor antagonist, for the prevention of itching associated with allergic conjunctivitis.
Quark Pharmaceuticals announced the results from its Phase 2 trial of PF-04523655 (RTP801I-14) for the treatment of diabetic macular edema (DME).
Genentech announced positive results from a Phase 3 trial of monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME).
Amicus Therapeutics announced initiation of its Phase 2 study of Amigal (migalastat hydrochloride) with enzyme replacement therapy (ERT) for the treatment of Fabry disease.
pSivida Corporation announced top-line readout results from two Phase 3 studies of Iluvien (sustained release fluocinolone acetonide insert) for the treatment of diabetic macular edema (DME).
Fera announced that Puralube (white petrolatum and mineral oil), a preservative free ophthalmic ointment, is available again to relieve the symptoms of dry eye.
RegeneRx Biopharmaceuticals announced that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease.
Regeneron and Bayer HealthCare announced results from their Phase 3 program of VEGF Trap-Eye (aflibercept ophthalmic injection solution) in patients with the neovascular form of age-related macular degeneration (wet AMD).
OCuSOFT announced that Zytaze (zinc citrate and phytase) has been approved as a medical food to provide nutritional support to enhance the effectiveness of botulinum toxin injections in the treatment of blepharospasm, hemifacial spasm or facial cosmetic procedures.
Alcon announced that TobraDex ST (tobramycin and dexamethasone ophthalmic suspension) has been made available for the treatment of steroid-responsive inflammatory ocular conditions where superficial bacterial ocular infection or risk of infection exists.
Fera announced that it has launched a preservative-free formulation of Garamycin (gentamicin sulfate ophthalmic ointment).
The FDA has approved Bromday (bromfenac ophthalmic solution, from ISTA) 0.09%, a nonsteroidal antiinflammatory drug (NSAID), for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
The FDA has warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices.
Alcon announced that it has expanded its Systane product line with the launch of Systane Balance lubricant eye drops for evaporative dry eye in patients with Meibomian Gland Dysfunction (MGD).
Merz Pharmaceuticals has launched Xeomin (incobotulinumtoxinA) for the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients and blepharospasm in adults previously treated with onabotulinumtoxinA.
ISTA Pharmaceuticals announced the results from its Phase 2 trial of Remura (bromfenac ophthalmic solution) for the treatment of dry eye disease.
The FDA has approved Ozurdex (dexamethasone intravitreal implant, from Allergan) for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.
Promedior announced that it has initiated a Phase 2a clinical trial of PRM-151 for the prevention of post-surgical scarring in glaucoma patients.
Merz Pharmaceuticals announced that the FDA has approved Xeomin (incobotulinumtoxinA) for the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients and blepharospasm in adults previously treated with onabotulinumtoxinA.
Fera has made available Neptazane (methazolamide tablets) for the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.
The FDA has approved Lucentis (ranibizumab injection, from Genentech) for the treatment of macular edema following retinal vein occlusion (RVO).