Wednesday, December 13, 2017| FDA Approval/Clearance, Intraocular Pressure, IOP, Omidria, Pattern Scanning Laser Trabeculoplasty (PSLT), Pediatric Ophthalmology, Regeneron Pharmaceuticals, Topcon Medical Systems, Wet AMD

EyewireTV -- PSLT on PASCAL Laser; Omidria Approved for Pediatric Patients

In this week’s EyewireTV, Topcon Medical Systems receives FDA clearance to offer Pattern Scanning Laser Trabeculoplasty (PSLT) for the reduction of IOP on its PASCAL Streamline Laser; and the FDA approves Omeros’ supplemental new drug application for Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% for use in pediatric patients. Also, Regeneron announces that the FDA has accepted for review the company's supplemental Biologics License Application for a 12-week dosing interval of Eylea in patients with wet AMD.

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Wednesday, December 06, 2017

EyewireTV - FDA Approves Light Adjustable Lens; MIPS Penalties

In this week's EyewireTV, the FDA approves RxSight's Light Adjustable Lens, the first IOL to enable refractive correction after cataract surgery; and Regeneron decides to end its clinical program of combination Eylea (aflibercept) and nesvacumab for the treatment of retinal diseases. Also, AAO warns that retina specialists and others who administer Medicare Part B drugs must act now to ensure they avoid paying penalties in 2019 due to CMS' Merit-Based Incentive Payment System (MIPS).

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Wednesday, November 29, 2017

EyewireTV - OIS Coverage Part 2: Ophthalmic Drugs

In this week's EyewireTV, executives of drug companies at the Ophthalmology Innovation Summit in New Orleans provide EyewireTV updates on their company's products and pipeline.

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Tuesday, November 21, 2017

EyewireTV — OIS Coverage Part 1: Ophthalmic Devices

In this week’s EyewireTV, executives of device companies at the Ophthalmology Innovation Summit in New Orleans provide EyewireTV updates on their company’s products and pipeline.

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Tuesday, November 07, 2017| Bausch+Lomb, FDA Approval/Clearance, Glaucoma, Hydrus™ Microstent, Ivantis, Nicox

EyewireTV - New Glaucoma Treatment Approved; PMA for Hydrus Microstent

In this week’s EyewireTV, Bausch + Lomb and Nicox receive FDA approval for glaucoma treatment Vyzulta (latanoprostene bunod 0.024%), and Ivantis submits its final premarket approval submission to the FDA for the Hydrus Microstent MIGS device.

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Wednesday, November 01, 2017| Alcon, Alcon, EyeQue, FDA Approval/Clearance, Inflammation, Kala Pharmaceuticals, Novartis, Visual Acuity

EyewireTV — Novartis Delays Alcon Decision; Kala Drug Candidate NDA

In this week’s EyewireTV, amid signs of a turnaround, Novartis delays a possible spinoff of Alcon until the first half of 2019; and Kala Pharmaceuticals submits a new drug application to the FDA for its postoperative ocular inflammation and pain treatment candidate Inveltys (KPI-121 1%). Also, EyeQue launches the EyeQue Insight visual acuity screener, a device that tests clarity of distance vision and tracks vision changes over time.

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