Wednesday, January 17, 2018

EyewireTV -- FDA Warns Imprimis Over Claims; New ASCRS Leader

In this week’s EyewireTV, the FDA issues a warning letter to Imprimis Pharmaceuticals, claiming the maker of compounded drugs made false or misleading claims about some of its formulations on the company’s website and Twitter account; and Bausch + Lomb receives CE Mark for the Stellaris Elite Vision Enhancement System, the company’s next-generation ophthalmic surgical platform. Also, the American Society of Cataract and Refractive Surgery names veteran industry executive Stephen Speares as its executive director.

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Wednesday, January 10, 2018

EyewireTV — Kala and Sun Provide Updates on DED Drug Candidates; Late-Stage AMD Candidate Fails

In this week’s EyewireTV, Kala Pharmaceuticals reports mixed results from two late-stage studies of its potential blockbuster dry eye disease candidate KPI-121 0.25%; and Sun Pharmaceutical submits a new drug application to the FDA for dry eye drug candidate OTX-101 (cyclosporine A, ophthalmic solution 0.09%). Also, Ohr Pharmaceutical suffers a major setback as its late-stage drug candidate for wet AMD fails to reach the primary efficacy endpoint.

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Wednesday, January 03, 2018

EyewireTV 2017 Year in Review - Part 2

In this week's EyewireTV, we take a look back at the major industry announcements and advancements in ophthalmology from the second half of 2017. The top stories include updated dry eye recommendations, the expanded commercialization of compounded drugs, femtosecond laser and OCT enhancements, manufacturing issues and setbacks of ophthalmic drug candidates, the first total solar eclipse in the United States in 37 years, the approval of the first IOL that enables refractive correction after cataract surgery, and the first gene therapy ever approved for an inherited disease.

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Wednesday, December 27, 2017

EyewireTV 2017 Year in Review — Part 1

We take a look back at the major industry announcements and advancements in ophthalmology in the first half of 2017. The top stories include a multi-billion-dollar acquisition of a major ophthalmic device maker, the approval of a new capsulotomy system, new indications for well-known anti-VEGF agents, the launch of an intranasal tear neurostimulator, and major advancements in IOL technology.

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Wednesday, December 13, 2017

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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