Wednesday, April 29, 2015

EyewireTV — Rhopressa Misses Phase 3 Endpoint, Shire CEO Interview

In this week's EyewireTV, Aerie Pharmaceuticals reports that its phase 3 trial of once-daily Rhopressa did not meet its primary efficacy endpoint of demonstrating noninferiority of IOP-lowering compared with twice-daily timolol; and the FDA clears the mVT Service, the first ophthalmic app designed to monitor AMD and diabetic retinopathy. In the feature, Flemming Ornskov, MD, chief executive officer of Shire, talks about the company’s increased focus on the ophthalmology market and the potential for lifitegrast to address an unmet need in the dry eye space. (2020 Views)

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Wednesday, April 22, 2015

EyewireTV — Industry News Roundup From the ASCRS Meeting in San Diego

In this week's EyewireTV, AcuFocus receives FDA approval for the Kamra inlay for the surgical correction of presbyopia; and Alcon releases a software upgrade for the LenSx laser system that allows for customized flap creation. Also, Abbott Medical Optics launches a new phaco system called the Compact Intuitiv. (3454 Views)

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Tuesday, April 14, 2015

EyewireTV — Lifitegrast Priority Review, Launch

In this week's EyewireTV, Shire achieves a key milestone as the FDA grants priority review designation for the company's dry eye treatment candidate, lifitegrast; and, an online marketplace designed to allow practitioners to learn, compare, rate, and purchase eye care technology, launches. Also, Ellex Medical introduces its multicolor scanning photocoagulator, Integre Pro Scan, in the United States. (1918 Views)

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Wednesday, April 08, 2015

EyewireTV — Omidria Launch, Phase 3 Postoperative Product Candidate Results

In this week's EyewireTV, Omeros announces the commercial launch in the United States of its lead eye drug Omidria (phenylephrine and ketorolac injection 1%/0.3%); and in a second phase 3 study, Ocular Therapeutix's product candidate, OTX-DP (sustained-release dexamethasone 0.4mg), meets the primary endpoint of absence of pain, but does not meet the primary endpoint of absence of inflammation. Also, Kala Pharmaceuticals announces positive top-line results from the phase 3 evaluation of its postoperative pain and inflammation drug candidate, KPI-121 (nanoparticle loteprednol etabonate MPP). (1961 Views)

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Wednesday, April 01, 2015

EyewireTV — Avedro CXL FDA Application Not Approved, Eylea New Indication

In this week's EyewireTV, the FDA decides not to approve Avedro’s new drug application for its corneal cross-linking platform, identifying areas of the application concerning the device that require additional information; and Lensar receives FDA clearance of five new performance upgrades, collectively called the Streamline advanced technology suite, to its Lensar Laser System. Also, the FDA expands the indication of Regeneron’s Eylea (aflibercept) to treat diabetic retinopathy in patients with diabetic macular edema. (2579 Views)

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Wednesday, March 25, 2015

EyewireTV — Actavis Completes Allergan Acqusition, EVA FDA Approval

In this week's EyewireTV, Actavis completes its acquisition of Allergan in a transaction valued at about $70.5 billion in cash and equity; and DORC receives FDA approval for the EVA integrated vitrectomy and phaco system. In the feature, leading ophthalmologists discuss how private practices and academic programs affect drug and product innovation. (2161 Views)

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Wednesday, March 18, 2015

New Clinical Findings for Cataract and Glaucoma Drug Candidates

In this week’s EyewireTV, Ocular Therapeutix announces positive topline data from a phase 3a clinical trial evaluating the safety and efficacy of its drug candidate, OTX-DP, for the treatment of ocular inflammation and pain following cataract surgery; and preclinical research by Aerie Pharmaceuticals shows that the company’s lead drug candidate, Rhopressa, has the potential to modify the course of glaucoma by arresting fibrosis. (1772 Views)

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Wednesday, March 11, 2015

EyewireTV - LessDrops Evaluation Results, US Drug Spending Soars

In this week's EyewireTV, Imprimis Pharmaceuticals and the Cleveland Eye Clinic announce preliminary results of an investigator-initiated evaluation examining the use of the company's proprietary LessDrops formulation; and Drug spending in the United States rose last year at the fastest rate in more than a decade, driven by soaring demand and price increases for specialty agents. Also, Carl Zeiss Meditec launches its next-generation perimetry system, the Humphrey Field Analyzer 3. (2584 Views)

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Wednesday, March 04, 2015

EyewireTV — Dry Eye Treatment NDA, AECOS Winter Symposium

In this week's EyewireTV, Shire submits a new drug application to the FDA for its investigational dry eye treatment lifitegrast; and following FDA approval, Alimera Sciences begins shipping its diabetic macular edema treatment Iluvien (fluocinolone acetonide). Also, physicians and industry members at the AECOS Winter Symposium in Aspen discuss the most significant takeaway messages from the meeting. (1888 Views)

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Wednesday, February 25, 2015

EyewireTV — FDA Advisory Committee Recommends Approval of Avedro's Cross-Linking Platform

In this week’s EyewireTV, a joint FDA advisory panel recommends approval of Avedro’s combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking; and Valeant agrees to acquire Salix Pharmaceuticals, a maker of gastrointestinal drugs, in anall cash deal valued at about $10.1 billion. Also, a large study shows that laser cataract surgery and standard phacoemulsification are equally safe procedures. (1868 Views)

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Thursday, February 19, 2015

EyewireTV — Protocol T Study Results, Avedro Cross-Linking FDA Hearing

Results of the government-sponsored Protocol T study show that three agents used to treat diabetic macular edema were effective and safe, however, the relative effect correlated with patients’ baseline visual acuities; and a date is set for an FDA advisory panel to review Avedro’s new drug application for its corneal cross-linking platform. (2551 Views)

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Wednesday, February 11, 2015

EyewireTV — Lucentis DR Approval, Caribbean Eye Highlights

In this week's EyewireTV, the FDA expands the approved use of Lucentis (ranibizumab) to treat diabetic retinopathy in patients with diabetic macular edema; and results of an international study show that the InnFocus MicroShunt implant lowered IOP and reduced reliance on glaucoma medication. Also, the annual Caribbean Eye meeting takes place in San Juan, Puerto Rico. Co-chair Dee Stephenson, MD, talks about the highlights of the meeting and what’s in store for next year. (1749 Views)

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