Développement en ophtalmologie
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NOVALIQ - crée une filiale américaine à Cambridge, dans le Massachusetts, pour consolider sa présence sur le marché en pleine croissance des soins oculaires aux États-Unis

NOVALIQ - crée une filiale américaine à Cambridge, dans le Massachusetts, pour consolider sa présence sur le marché en pleine croissance des soins oculaires aux États-Unis | Développement en ophtalmologie | Scoop.it
Novaliq GmbH, une société pharmaceutique spécialisée avec une plateforme disruptive d’administration médicamenteuse transformant des médicaments peu s
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NOVALIQ - annonce le recrutement du premier patient pour son essai SEECASE de Phase II portant sur le NOV03 dans le traitement de la sécheresse oculaire

NOVALIQ - annonce le recrutement du premier patient pour son essai SEECASE de Phase II portant sur le NOV03 dans le traitement de la sécheresse oculaire | Développement en ophtalmologie | Scoop.it

Novaliq GmbH, une société pharmaceutique spécialisée avec une plateforme disruptive d’administration médicamenteuse transformant des médicaments peu solubles en produits ophtalmologique

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KALVISTA PHARMACEUTICALS - Initiates Phase 2 Clinical Trial for KVD001 and Phase 1 Trial for KVD 900

KALVISTA PHARMACEUTICALS - Initiates Phase 2 Clinical Trial for KVD001 and Phase 1 Trial for KVD 900 | Développement en ophtalmologie | Scoop.it

KVD001 is a small molecule plasma kallikrein inhibitor administered by intravitreal injection for the potential treatment of DME. The Phase 2 trial will consist of approximately 123 patients in the United States who have discontinued treatment with anti-VEGF therapy, and who still have significant edema and reduced visual acuity. This sham-controlled, double-masked clinical trial will evaluate two dose levels of KVD001. Four intravitreal injections, or sham, will be administered over three months with a three month follow up period. Efficacy endpoints include best corrected visual acuity (BCVA), central subfield thickness (CST), and the diabetic retinopathy severity scale (DRSS). The safety and tolerability of monthly dosing of KVD001 will also be assessed. Top-line results are expected in the second half of 2019. 

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NIH discovery brings stem cell therapy for eye disease closer to the clinic

NIH discovery brings stem cell therapy for eye disease closer to the clinic | Développement en ophtalmologie | Scoop.it
Stem cell-derived retinal cells need primary cilia to support survival of light-sensing photoreceptors.
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MOLECULAR PARTNERS & ALLERGAN - Allergan exerce des options sur deux produits 

MOLECULAR PARTNERS & ALLERGAN - Allergan exerce des options sur deux produits  | Développement en ophtalmologie | Scoop.it
Allergan, partenaire de collaboration de Molecular Partners, va exercer deux options pour le développement et la commercialisation de produits candidats, a annoncé mercredi le... | 3 janvier 2018
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GLAUKOS - submits IDE application for iStent infinite three-stent system

GLAUKOS - submits IDE application for iStent infinite three-stent system | Développement en ophtalmologie | Scoop.it
Glaukos Corporation has submitted an investigational device exemption application to the FDA to study the iStent infinite trabecular micro-bypass system, a three-stent device designed to reduce IOP in cases of refractory glaucoma in a standalone procedure, according to a company press release.The company proposed to conduct a “prospective, multicenter, single-arm clinical trial to evaluate
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PROQR - Dystrophic EB Therapy QR-313 Granted Orphan Drug Status by EMA

PROQR - Dystrophic EB Therapy QR-313 Granted Orphan Drug Status by EMA | Développement en ophtalmologie | Scoop.it
The European Medicines Agency (EMA) granted orphan drug designation to ProQR’s QR-313 for the treatment of dystrophic epidermolysis bullosa.
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OMEROS - FDA approves Omidria for pediatric patients

OMEROS - FDA approves Omidria for pediatric patients | Développement en ophtalmologie | Scoop.it
The FDA has approved a supplemental new drug application from Omeros to expand the indication for Omidria for use in pediatric patients, according to a company press release.Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution) prevents intraoperative miosis and reduces postoperative pain during cataract surgery or IOL replacement.
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AERIE PHARMACEUTICALS - announces FDA approval of Rhopressa

AERIE PHARMACEUTICALS - announces FDA approval of Rhopressa | Développement en ophtalmologie | Scoop.it
Aerie Pharmaceuticals recently announced the FDA approval of Rhopressa, a first-in-class therapy for the treatment of patients with open-angle glaucoma and other diseases of the eye. Rhopressa (netarsudil ophthalmic solution 0.02%) is a once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. The drop was approved by the FDA ahead of the scheduled
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EYENOVIA - Eyenovia eyes $35M IPO to trial smart ocular delivery tech

EYENOVIA - Eyenovia eyes $35M IPO to trial smart ocular delivery tech | Développement en ophtalmologie | Scoop.it
Eyenovia has filed to raise up to $35 million in an IPO. The financing will support late-phase trials of candidates based on Eyenovia’s device, which uses inkjet printing technology to deliver small doses of drug to the eye.
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EYEGATE & VALEANT - EyeGate earns milestone payment based on EGP-437 trial enrollment

EYEGATE & VALEANT - EyeGate earns milestone payment based on EGP-437 trial enrollment | Développement en ophtalmologie | Scoop.it
By achieving 75% enrollment in the trial, EyeGate earned a milestone payment under a licensing agreement with a subsidiary of Valeant Pharmaceuticals.
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FFB - Benjamin Yerxa Named Foundation Fighting Blindness CEO

FFB - Benjamin Yerxa Named Foundation Fighting Blindness CEO | Développement en ophtalmologie | Scoop.it

The Foundation Fighting Blindness (FFB) today announced that it has selected Benjamin Yerxa, a biotechnology and drug development executive, as its Chief Executive Officer, effective immediately.

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TEVA - confirms plan to reduce workforce by 14,000 to save $3bn

TEVA - confirms plan to reduce workforce by 14,000 to save $3bn | Développement en ophtalmologie | Scoop.it
Teva Pharmaceutical Industries will reduce its workforce by 14,000, rejig its generics portfolio and speed up optimization of its plant network as part of a $3bn (€2.5bn) cost saving plan.
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KALA PHARMACEUTICALS - Announces Topline Results for Two Phase 3 Trials (STRIDE 1 and STRIDE 2) of KPI-121 0.25% in Dry Eye Disease

KALA PHARMACEUTICALS - Announces Topline Results for Two Phase 3 Trials (STRIDE 1 and STRIDE 2) of KPI-121 0.25% in Dry Eye Disease | Développement en ophtalmologie | Scoop.it
Kala Pharmaceuticals today announced topline results from its two Phase 3 clinical trials in patients with dry eye disease.
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ALLERGAN - supprime 1.000 emplois pour faire des économies

ALLERGAN - supprime 1.000 emplois pour faire des économies | Développement en ophtalmologie | Scoop.it

Allergan, a annoncé mercredi 3 janvier la suppression de 1.000 emplois, soit 5,55% de ses effectifs, dans le cadre d'un plan de restructuration visant à économiser jusqu'à 400 millions de dollars par an. Le laboratoire pharmaceutique va également fermer des usines et renoncer à recruter 400 personnes comme initialement prévu. Ces décisions visent à faire des économies et à compenser la perte d'exclusivité sur certains médicaments, affirme Allergan, ajoutant que les commerciaux allaient être les plus touchés. 

Restasis, le traitement d'Allergan contre les yeux secs, est soumis depuis peu à une forte concurrence. Ce médicament, qui a enregistré 1,5 milliard de dollars de ventes en 2016, est l'un des plus importants en termes de ventes pour le groupe, numéro 2 mondial dans l'ophtalmologie avec ses traitements du glaucome, de la sécheresse oculaire et des maladies de la rétine.

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MOMENTA & MYLAN - Momenta and Mylan Announce Clinical Trial of Proposed Aflibercept Biosimilar

MOMENTA & MYLAN - Momenta and Mylan Announce Clinical Trial of Proposed Aflibercept Biosimilar | Développement en ophtalmologie | Scoop.it
Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, a proposed biosimilar of the anti–vascular endothelial growth factor (anti-VEGF) therapy aflibercept, referenced on Eylea.
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OPHTHEA - Initiates OPT-302 Diabetic Macular Edema Clinical Trial 

OPHTHEA - Initiates OPT-302 Diabetic Macular Edema Clinical Trial  | Développement en ophtalmologie | Scoop.it

Opthea Limited, a late stage biopharmaceutical company developing novel biologic therapies to treat.

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PIXIUM VISION - reçoit l'autorisation de la FDA pour une étude clinique de son implant rétinien PRIMA aux Etats-Unis

PIXIUM VISION - reçoit l'autorisation de la FDA pour une étude clinique de son implant rétinien PRIMA aux Etats-Unis | Développement en ophtalmologie | Scoop.it
Pixium Vision reçoit l'autorisation de la FDA pour une étude clinique de son implant rétinien PRIMA aux Etats-Unis


L'étude de... | 4 janvier 2018
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NICOX - Dr. Tomas Navratil nommé Head of Development de Nicox

NICOX - Dr. Tomas Navratil nommé Head of Development de Nicox | Développement en ophtalmologie | Scoop.it

Nicox annonce la nomination du Dr. Tomas Navratil en qualité de Vice President et Head of Development, à compter du 1er janvier 2018. Dans le cadre de cette fonction nouvellement créée, le Dr. Navratil dirigera toutes les activités de développement cliniques et non cliniques de la Société et reportera au Dr. Michael Bergamini, Executive Vice President et Chief Scientific Officer de Nicox.

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B+L & VALEANT - Receives FDA Approval of LUMIFY™ - The Only Over-The-Counter Eye Drop With Low-Dose Brimonidine For The Treatment Of Eye Redness

B+L & VALEANT - Receives FDA Approval of LUMIFY™ - The Only Over-The-Counter Eye Drop With Low-Dose Brimonidine For The Treatment Of Eye Redness | Développement en ophtalmologie | Scoop.it
Bausch + Lomb and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., today announced that the FDA has approved LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%) as the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. Brimonidine, which was first approved by the FDA in 1996 for intraocular pressure (IOP) reduction in glaucoma patients, is available at higher doses in prescription eye care products.
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SPARK THERAPEUTICS - FDA approves Luxturna for inherited retinal dystrophy

SPARK THERAPEUTICS - FDA approves Luxturna for inherited retinal dystrophy | Développement en ophtalmologie | Scoop.it
The FDA announced the approval of Luxturna to treat children and adult patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.Luxturna (voretigene neparvovec, Spark Therapeutics) is the first directly administered gene therapy approved in the United States to target a disease caused by mutations in a specific gene, according to an FDA news release.
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SANTEN - Santen’s intravitreal sirolimus for noninfectious posterior segment uveitis not approved

SANTEN - Santen’s intravitreal sirolimus for noninfectious posterior segment uveitis not approved | Développement en ophtalmologie | Scoop.it
The FDA announced that it is unable to approve Santen Pharmaceutical’s new drug application for intravitreal sirolimus, an investigational treatment for noninfectious posterior segment uveitis, according to a company press release.
A complete response letter to the NDA “requests additional substantiating evidence to demonstrate the efficacy” of intravitreal sirolimus in treating
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Patient organization fights to preserve pharmaceutical tax credits for development of orphan therapies in ophthalmology

Patient organization fights to preserve pharmaceutical tax credits for development of orphan therapies in ophthalmology | Développement en ophtalmologie | Scoop.it
Foundation Fighting Blindness USA (FFB), a US patient organisation advocating supports and research for individuals with retinal diseases, has openly criticized plans by the Trump administration to cut tax credits designed to encourage the development of treatments for rare disorders. The Orphan Tax Credit, a part of the US Orphan Drug Act 1983, provides tax credits on the cost of clinical trials for drugs to treat rare disorders. The incentive acts as an encouragement for pharmaceutical companies to develop treatments for rare disorders which otherwise may not provide a sufficient level of profit to justify the expense and risk involved in drug development. The federal Orphan Drug Credit provides a tax credit of 50% of the “qualified clinical testing expenses”, as specified under the Federal Food, Drug and Cosmetic Act. A number of orphan treatments are under development for the treatment of retinal disorders, including therapies from Spark Therapeutics and AGTC.
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SCIFLUOR - Announces Positive Top-Line Results of Phase 1/2 Study of SF0166 Eye Drops to Treat Wet Age-Related Macular Degeneration

SCIFLUOR - Announces Positive Top-Line Results of Phase 1/2 Study of SF0166 Eye Drops to Treat Wet Age-Related Macular Degeneration | Développement en ophtalmologie | Scoop.it

Demonstrated safety with no drug-related serious adverse events Improvements in vision along with significant decreases in central retinal thickness and fluid levels reported

Preparation of Phase 2 trials underway

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ROCHE & GENENTECH - Twin lampalizumab trials fail to impact area of geographic atrophy

ROCHE & GENENTECH - Twin lampalizumab trials fail to impact area of geographic atrophy | Développement en ophtalmologie | Scoop.it
NEW ORLEANS — Lampalizumab failed to impact geographic area compared with sham treatment in two identically designed phase 3 studies — Chroma and Spectri, according to a speaker.Giving 48-week topline results of the Spectri trial of lampalizumab at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting, Jeffrey S. Heier, MD, said, “Lampalizumab did not
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