News

Phase III trial shows FloraGlo lutein (OmniActive Health Technologies) fails to protect against AMD

A multicenter, randomized clinical trial that included people at high risk for progression to advanced Age-related Macular Degeneration (AMD), shows that adding lutein and zeaxanthin, and the omega-3 fatty acids DHA and EPA, as found in FloraGlo lutein from OmniActive Health Technologies, to a formulation of antioxidant vitamins and minerals (so-called AREDS formulation) that has shown effectiveness in reducing risk, ...

FDA Advisory Committee rejects Melblez Kit (Delcath) for Ocular melanioma metastatic to the Liver

Delcath Systems, Inc. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable Ocular melanoma metastatic to the Liver do not outweigh the risks associated with ...

Positive trial results for OMS 302 (Omeros Corporation) in Cataract surgery

Analyses of Phase II and Phase II clinical data show the favorable impact of OMS 302 (ketorolac and phenylephrine), from Omeros Corporation, on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement (ILR) surgery for Cataracts. In patients receiving standard-of-care preoperative mydriatic topical drops, OMS 302 reduces the occurrence of pupil constriction of 2.5 mm or more and ...

FDA approves Simbrinza (Alcon/Novartis) for Glaucoma and Ocular Hypertension treatment

The FDA has given approval for Simbrinza Suspension, from Alcon/Novartis, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle Glaucoma or Ocular Hypertension.Elevated IOP is the only modifiable risk factor for Glaucoma. Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible ...

Nice recommends Lucentis (Novartis) for Macular Oedema following RVO

NICE has issued final draft guidance recommending Lucentis (ranibizumab), from Novartis, as a treatment for sight problems caused by Macular Oedema following central retinal vein occlusion (CRVO), provided Novartis makes the drug available under an agreed patient access scheme (PAS). It also recommends it as a treatment option following branch retinal vein occlusion (BRVO) when standard treatment with laser photocoagulation ...

FDA recommends Trulign Toric (Bausch & Lomb) for Cataract surgery

The FDA's Ophthalmic Devices Panel voted 10-1 to recommend the approval of Bausch & Lomb Opthalmic's Trulign Toric intraocular lens to repair vision after Cataract surgery. The Trulign Toric intraocular lens is a multi-piece implant inserted into the capsular bag of the eye to correct problems stemming from cataract removal, restoring vision without spectacles.

The filing is based on a ...

FDA approves Prolensa (Ista/Bausch & Lomb) for postoperative Ocular Inflammation

The FDA has approved Prolensa (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, from Ista/Bausch & Lomb, for the treatment of postoperative Ocular Inflammation and reduction of Ocular pain in patients who have undergone cataract surgery. The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Twice as many patients as vehicle (46 ...

Shire acquires SARcode Bioscience and Phase III lifitegrast for Dry Eye Disease

Shire plc will acquire SARcode Bioscience Inc., which brings a new phase III compound – Lifitegrast – currently under development for the signs and symptoms of Dry Eye Disease, into Shire’s portfolio. Shire anticipates launching lifitegradt in the United States as early as 2016 pending a positive outcome of the phase III clinical development program and regulatory approvals. Shire is ...

BromSite(InSite Vision) success in Phase III trial for Cataract Surgery

InSite Vision Incorporated has announced top-line results from its recently completed Phase III clinical trial of BromSite(ISV-303) for the reduction of inflammation and pain after Cataract Surgery. BromSite achieved statistically significant superiority compared to vehicle in alleviating ocular pain and inflammation among patients following Cataract Surgery. InSite Vision plans to rapidly initiate the second Phase III trial of BromSite in ...

European Commission approves Jetrea (Alcon/Novartis) to treat Vitreomacular Traction

Alcon,a division of Novartis, has announced that the European Commission has approved Jetrea (intravitreal injection ocriplasmin) in the EU for the treatment of Vitreomacular Traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss, and is estimated to affect between ...

IQWiG rejects Eylea for treatment of "wet" Age Related Macular Degeneration

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) reported in a preliminary benefit assessment that Eylea (aflibercept) from BayerHealthCare has "no additional benefit" over Lucentis(ranibizumab), the comparator requested by Germany's Federal Joint Committee (G-BA) to treat wet age-related macular degeneration (AMD). The institute said the data Bayer submitted comparing Eylea and Lucentis were "not suitable" because Lucentis was ...

FDA approves Argus II Retinal Prosthesis System for Retinitis Pigmentosa

The FDA on 14 February 2013 approved the Argus II Retinal Prosthesis System from Second Sight Medical Products Inc., the first implanted device to treat adult patients with advanced Retinitis Pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces ...

EU approves Optisharp (DSM Nutritional Products) for nutritional use

The European Commission approved the use of nature-identical Optisharp (zeaxanthin), from DSM Nutritional Products, as an ingredient in food supplements as a way to improve visual performance. The decision follows a positive EFSA safety assessment delivered on September 13, 2012, which concluded that the use level for zeaxanthin does not raise safety concerns. Studies have suggested that high concentration of ...

Latanoprostene bunod (Bausch & Lomb) enters Phase III for Glaucoma and Ocular Hypertension

Bausch + Lomb, have announced that Bausch + Lomb has initiated its Phase III clinical program of latanoprostene bunod (previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure (IOP) in patients with Glaucoma or Ocular Hypertension. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2 alpha analog licensed by Nicox to Bausch + Lomb.

This pivotal Phase ...

CHMP recommends Jetrea (Alcon)for treatment of Vitreomacular Traction.

Alcon, the eye care division of Novartis, announces the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Jetrea (ocriplasmin), for the treatment of Vitreomacular Traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is an age-related progressive condition that ...

EMA rejects Raxone/Catena (Santhera) as a treatment for Leber's Hereditary Optic Neuropathy

Santhera Pharmaceuticals has announced that it has received a negative opinion on its Marketing Authorization Application (MAA) for Raxone (idebenone) as a potential therapy for Leber's Hereditary Optic Neuropathy (LHON). The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has notified Santhera that a narrow majority of CHMP members deemed Raxone not approvable at this time. Santhera ...

Study shows Anti-VEGF treatments could cause harmful side-effects in the eye

A new study reveals that increasingly aggressive therapies that block VEGF, such as VEGF TRAP-EYE, from Bayer HealthCare, could cause damage in treating eye diseases. Scientists discovered inhibiting anti-VEGF might have a harmful effect on the tissue responsible for producing the fluid that bathes the eye, medically termed the ciliary body. Investigators simulated the VEGF-A activity in adult mice and ...

FDA will review Procysbi (Raptor Pharma) in April 2013

Raptor Pharmaceutical Corp. announced that the FDA will require additional time to complete its review of the New Drug Application (NDA) for RP103 (Procysbi), for the potential treatment of Nephropathic Cystinosis. In a notice received from the FDA, the initial Prescription Drug User Fee Act (PDUFA) goal date has been extended from January 30, 2013 to April 30, 2013. The ...

Luveniq (Isotechnika) fails Phase III trial for treatment of Uveitis

Isotechnika Pharma Inc. announced that the Phase III clinical study using Luveniq (voclosporin) for the treatment of non-infectious Uveitis, conducted by Lux Biosciences, under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does ...

European Commission approves Elyea (Bayer) for treatment of "wet" AMD.

Bayer HealthCare announced that Eylea (aflibercept solution for injection), also known in the scientific literature as VEGF Trap-Eye, has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligrams (mg). Eylea treatment is initiated with one injection per month for three consecutive doses, followed ...

Positive results in Phase III trial of OMS 302 (Omeros Corporation) in patients undergoing Cataract Surgery

In the second of two pivotal Phase III clinical trials evaluating OMS 302, from Omeros Corporation, in patients undergoing intraocular lens replacement surgery for Cataracts, OMS 302 met its co-primary endpoints by demonstrating statistically significant maintenance of intraoperative mydriasis (pupil dilation) and statistically significant reduction of pain in the early postoperative period. Mydriasis is critical to the safety and surgical ...

Positive topline results for SAR 1118 (SARcode) for treating Dry Eye Disease

Topline results from OPUS-1, a pivotal Phase III study of SAR 1118 (lifitegrast ophthalmic solution), from SARcode, for the treatment of Dry Eye Disease demonstrate the drug is superior to placebo in the improvement of inferior and total corneal staining scores from baseline to week 12. Lifitegrast also significantly improved the most commonly reported symptoms of dry eye disease in ...

FDA approves Jetrea (Thrombogenics NV) for the treatment of Vitreomacular Adhesion

The FDA has approved Jetrea (ocriplasmin), from Thrombogenics NV, in the US for the treatment of symptomatic Vitreomacular Adhesion (VMA), a progressive sight threatening condition. Jetrea is the first pharmacological agent to be approved for this indication. The approval was based on the data from ThromboGenics' Phase III program where Jetrea was shown to be superior to placebo for the ...

NICE recommends Lucentis (Novartis) for Diabetic Macular Oedema

NICE will now recommend Lucentis (ranibizumab) from Novartis for the treatment of Diabetic Macular Oedema. This is a change from previous draft guidance, which recommended against using the drug for this condition, The new decision is made after after Novartis agreed to drop the price of its drug.

In draft guidance, Lucentis is now recommended as an option ...

FDA approves Eylea (Regeneron) for Macular Oedema following Central Retinal Vein Occlusion

The FDA has approved Eylea (aflibercept) Injection, from Regeneron, for the treatment of Macular Oedema following Central Retinal Vein Occlusion (CRVO). The recommended dose for Eylea is 2 milligrams (mg) every 4 weeks (monthly). The approval of Eylea for Macular Oedema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies.

In both studies, the ...

CHMP recommends Eylea (Bayer HealthCare) for wet AMD

On 20 September 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Eylea (aflibercept), 40 mg/ml, solution for injection intended for the treatment of Neovascular (wet) Age-related Macular Degeneration (AMD). The applicant for this medicinal product is Bayer Pharma AG. The active substance of ...

Ocriplasmin(Novartis/Thrombogenics) studies for Vitreomacular Adhesion published in NEJM

Novartis has announced the New England Journal of Medicine (NEJM) published the results of two Phase III studies, Studies 006 and 007, of the investigational eye treatment Jetrea ( ocriplasmin). The studies including 652 patients found that ocriplasmin, significantly resolved vitreomacular traction and closed macular holes compared to placebo in patients with vitreomacular adhesion.

Vitreomacular adhesion (VMA), including vitreomacular ...

FDA approves Lucentis (Genentech) for treatment of Diabetic Macular Edema

The FDA on 10 August 2012 approved Lucentis (ranibizumab injection) from Genentech for the treatment of Diabetic Macular Edema (DME), a sight-threatening eye disease that occurs in people with diabetes. An injection of the drug is administered once a month by a health care professional. Lucentis is intended to be used along with good diabetic blood sugar control. DME is ...

NICE rejects Iluvien(Alimera Sciences)for DME treatment

NICE (The National Institute for Health and Clinical Excellence) has now released a draft recommendation that does not back the use of the sustained-release intravitreal implant for the treatment of visual loss caused by chronic Diabetic Macular Edema (DME), NICE did not find the treatment cost-effective. This is a draft appraisal, and NICE expects to issue its final guidance in ...

FDA Advisory Committee recommends ocriplasmin(Thrombogenics) for treatment of Vitreomacular Adhesions

ThromboGenics NV announced that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion (VMA). The Committee voted 10 to 0 at its meeting that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweigh the potential risks.Symptomatic VMA is a progressive condition that if ...

FDA approves Healon EndoCoat OVD (Abbott Medical Optics) for use in Cataract extraction

The FDA has approved the use of Healon EndoCoat OVD, from Abbott Medical Optics, an ophthalmic viscosurgical device intended for use as a surgical aid in Cataract extraction and intraocular lens (IOL) implantation. This clear, viscous, protective gel formula is injected into a patient's eye to protect and coat the eye during surgery, reducing trauma to the inside layer of ...

FDA Advisory Committee recommends Lucentis (Genentech) for treatment of Diabetic Macular Edema

The FDA Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) from Genentech/Roche for treatment of Diabetic Macular Edema (DME). The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows ...

I-Stent (Glaukos Corporation) is FDA approved for Cataract Surgery

The iStent Trabecular Micro-Bypass Stent System, Model GTS100R/L, from Glaukos Corporation, was approved by the FDA on 26 June 2012. This is the first device approved for use in combination with cataract surgery to reduce pressure inside the eye (intraocular pressure) in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being treated with medication ...

FDA approves EnVista acrylic intraocular lens (Bausch & Lomb Ophthalmic) for Cataract Surgery

The FDA has approved the EnVista hydrophobic acrylic intraocular lens (IOL), from Bausch + Lomb Ophthalmic, for Cataract Surgery. The EnVista lens combines aspheric, aberration-free optics designed to deliver enhanced contrast sensitivity and better vision quality, with a clinically proven glistening-free material. Glistenings are fluid-filled microvacuoles that can form within an IOL, and are common in some hydrophobic acrylic IOLs. ...

Positive results for Optina (Ampio) in patients with Diabetic Macular Oedema

Ampio announces positive clinical trial results for the treatment of Diabetic Macular Oedema with orally administered Optina (danazol). The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT). The study included 32 patients with moderate to severe Diabetic Macular Oedema (range 316-707 microns) that were treated orally with either placebo or one ...

Early trial for Retinitis Pigmentosa using microchip from Retina Implant AG

Two patients in a UK trial of the retinal implant, from Retina Implant AG, to treat Retinitis Pigmentosa have regained partial eyesight. The multi-centre phase of this trial expanded in 2011 to include additional sites in Germany, Hong Kong and the UK. Sites in Italy and Hungary are also under agreement to participate. The UK trials will include 12 patients ...

CATT trial comparison Avastin and Lucentis for wet AMD

At two years, Avastin (bevacizumab) from Genentech/Roche and Lucentis (ranibizumab injection) developed by Roche and marketed by Novartis outside the USA are two widely used drugs to treat Age-related Macular Degeneration (AMD), improve vision when administered monthly or on an "as-needed" basis, although greater improvements in vision were seen with monthly administration for this common, debilitating eye disease, according to ...

FDA approves Femtosecond (Abbott Medical Optics) for Corneal Surgery

The FDA has approved use of the iFS Advanced Femtosecond Laser from Abbott Medical Optics, to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery. With this new clearance, the iFS Laser now gives surgeons the ability to make precise, bladeless arcuate incisions during surgery and customize the incision for each individual patient.Factors such as placement, length, ...

ThromboGenics resubmits BLA for ocriplasmin with the FDA

ThromboGenics has resubmitted a Biologics License Application with the FDA for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic Vitreomacular Adhesion including macular hole. In February 2012 the FDA indicated that it intended to assign a Priority Review designation to the original BLA submission for the same indication filed in December 2011. Today's re-submission will allow ThromboGenics to ...

Positive update from Phase II trial of Optina (Ampio Pharma) for Diabetic Macular Oedema

An interim review of the first 50% of patients enrolled in a Phase II trial of Optina (danzol), from Ampio Pharma, for Diabetic Macular Oedema has been completed. A preliminary assessment of the primary end point (as determined by optical coherence tomography) indicates a beneficial and consistent effect with the ultra-low dose of Optina at 4 and 12 weeks of ...

FDA approves first generic Lexapro for Depression and Anxiety Disorder

The FDA has approved the first generic version of Lexapro (escitalopram tablets) to treat Depression and generalised Anxiety Disorder in adults. The generic is produced by Teva Pharmaceutical Industries/IVAX Pharmaceuticals who will be marketing generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA ...

First Patient Treated in Phase III Study of RiaSTAP (CSL Behring) to Control Bleeding in Aortic Aneurysm Surgery

The first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of RiaSTAP (fibrinogen concentrate (Human)), from CSL Behring, in controlling microvascular bleeding during Aortic Aneurysm Surgery. The purpose of this study is to demonstrate that FCH can reduce intraoperative bleeding and, therefore, the volume of donor blood products (e.g., fresh ...

Omega-3 fatty acids study and brain aging

Trial data published in Neurology from 1500 dementia-free participants who underwent MRI scanning suggested that diet levels in omega-3 fatty acids could cause the brain to age faster and lose memory and thought abilities. Regular consumption of foods rich in omega-3 fatty acids can slow mental decline. People with DHA in the lowest quartile of the partipants had lower brain ...

Positive outcome to EU decentralized approval of Iluvien (Almeria Sciences) for DME

There has been a positive outcome of the Decentralized Procedure (DCP) for Iluvien (fluocinolone acetonide), from Alimera Sciences, in Europe for treatment of Diabetic Macular Oedema (DME). The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all ...

Regeneron files Eylea(VEGF TRAP-EYE) at FDA for CRVO

Based on the results of the GALILEO study and one otherstudy Regeneron Pharmaceuticals, has submitted a supplemental Biologics License Application (sBLA) in the US for the CRVO indication and has been granted an FDA action date of 23 September 2012....

FDA approves Zioptan (Merck Inc.)for Glaucoma and Ocular Hypertension

The FDA has approved Zioptan (tafluprost opthalmic solution) from Merck Inc. for reduction of elevated intraocular pressure in patients with open-angle Glaucoma or Ocular Hypertension. The drug is also approved in the UK, Spain and Italy....

Aganocide (Novabay Pharma) enters Phase IIb trial for Adenoviral Conjunctivitis

NovaBay Pharmaceuticals, Inc. is developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic treatment and prevention of infections.The company has announced that it has selected multiple organizations to manage the Company's Phase IIb clinical study of NVC-422 for the treatment of Adenoviral Conjunctivitis, a form of "pink eye." This global study is anticipated to enroll up to 450 patients ...

New device is FDA filed by Genentech to extend period of release of Lucentis

Lucentis(ranibizumab) from Genentech/Roche is approved in the USA for AMD and Macular Edema.The drug is administered by monthly injection into the eye. A new implantable ocular device from ForSight VISION 4 will release Lucentis over a period of months. Genetech/Roche have acquired rights to the device and Genentech has filed an application at the FDA...

Ocriplasmin (Thrombogenics) filed at FDA for Vitreomacular Adhesion.

Thrombogenics has submitted a biologics license application (BLA) to the FDA for ocriplasmin intravitreal injection 2.5mg/mL as a treatment for symptomatic Vitreomacular Adhesion, including macular hole, a progressive condition that if left untreated generally leads to significant visual distortion, deterioration in vision and in some cases central blindness. The condition affects about 500,000 people annually in the US and the ...

CHMP recommends Nevanac(Alcon/Novartis) for Diabetic Macular Oedema following Cataract Surgery

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on a new indication for Nevanac (nepafenac), from Alcon/Novartis, as follows: "Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients". Cystoid macular edema (CME) can occur following routine, uncomplicated cataract surgery. Because macular oedema is ...

FDA approves Eylea (Regeneron) for wet AMD

The FDA has approved Eylea (aflibercept ophthalmic solution), from Regeneron, to treat patients with wet (neovascular) Age-related Macular Degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older. There are two forms of AMD, a wet form and a dry form. The wet form of AMD includes the growth of abnormal blood vessels which ...

AzaSite and DexaSite (InSite Vision) enter Phase II for Blepharitis

InSite Vision Inc. commences a 900 patient Phase III trial (DOUBle study)for Azasite Plus ( dexamethasone plus azithromycin)-ISV 502 and DexaSite (dexamethasone)-ISV-305 both using its DuraSite drug delivery platform in the treatment of chronic Blepharitis (or lid margin disease). This condition is an inflammation of the eyelid for which there is no FDA approved treatment....

FDA requires two new trials for Iluvien(Alimera Sciences) for Diabetic Macular Oedema

The FDA now requires an additional two trials for Iluvien (fluocinolone acetonide) from Alimera Sciences before granting an approval for Diabetic Macular Oedema associated with Diabetic Retinopathy as the company has not provided sufficient data. This may mean a two year delay to American approval. Alimera Sciences plans to file in the UK this month....

First Implantable Miniature Telescope (VisionCare) used for patient with AMD

The first patient has received the FDA-approved Implantable Miniature Telescope, a visual prosthetic device from VisionCare, indicated to improve vision in patients with end-stage Age-related Macular Degeneration (AMD). The IMT was approved by the FDA in July 2010 and this first procedure marks the launch of VisionCare's CentraSight treatment program, a new patient care program utilizing the first-of-kind telescope implant ...

Luveniq is withdrawn from EMA for chronic non-infectious Uveitis

Lux Biosciences has withdrawn Luveniq (voclosporin oral) from the EMA as a treatment for chronic non-infectious Uveitis following a negative opinion from the CHMP which considered that the benefits of the drug did mnot outweight its risks....

Ocriplasmin for Vitromacular Adhesion is filed at EMA

The European Medicines Agency has accepted for review ocriplasmin (2.5 mg/ml, solution for injection) from Thrombogenics ,for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole. Ocriplasmin's MAA will be evaluated through the EMA's centralised procedure with an official start date of 19 October 2011 and, if approved, the product will gain marketing authorisation for all EU Member States ...