October 2016 Newsletter

October 27, 2016:

AAO Meeting Features New Refractive, Glaucoma, Dry Eye Technologies

Attendance fell short of 2015 conference in Las Vegas.

October 27, 2016:

EU Tightens Medical Device Regulatory Process

Manufacturers will have to apply for a new CE mark under proposed rules.

October 27, 2016:

Alcon Launches CyPass Micro-Stent for Mild to Moderate Glaucoma

The device gained FDA approval in July 2016, becoming the second MIGS implant available in the US market.

October 27, 2016:

Genentech’s Lucentis Prefilled Syringe Gains US FDA Approval

The product is approved to treat people with wet AMD and ME after RVO, similar to the Lucentis 0.5 mg vial.

October 27, 2016:

Ocular Therapeutix, Regeneron to Collaborate on Sustained-Release Form of Eylea for Retinal Disease

Agreement could be worth more than $300 million in licensing, milestone payments.

October 27, 2016:

Regeneron Combination Therapy Fails to Meet Endpoint in Phase II Wet AMD Study

The product candidate did not demonstrate improvement over Eylea monotherapy at 12 weeks.

October 27, 2016:

2016 AAO Meeting: Cataract Sessions Focus on Improved Visual Outcomes

One speaker discussed how Abbott’s Symfony IOL is driving patient demand.

October 27, 2016:

2016 AAO Meeting: Refractive Surgeons Discuss Role for SMILE in Treating Patients

In one small study, SMILE and topo-guided LASIK produced similar results.

October 27, 2016:

2016 AAO Meeting: Presbyopia Sessions Provide Updates on Early-Stage Therapies

Encore Vision’s topical drops are completing Phase I/II study in 75 patients.

October 27, 2016:

2016 AAO Meeting: Abbott Hides New Refractive Suite

The iVyence excimer laser is slightly smaller than the VISX STAR S4 laser.

October 27, 2016:

2016 AAO Meeting: Retina Sessions Discuss Instruments Pushing New Boundaries in Surgery

Products included Alcon’s NGENUITY heads-up display, Bausch + Lomb’s disposable AUTOINSERTER, and Katalyst’s 3-D printed retinal forceps grip.

October 27, 2016:

2016 AAO Meeting: OCT Angiography Module Among Diagnostic Technology Unveiled

Heidelberg joins Carl Zeiss Meditec and Optovue in this segment.

October 27, 2016:

2016 AAO Meeting: New Dry Eye Product Approval Reignites Interest in Treatments

Allergan awaits FDA approval of neurostimulator; TearScience presents results for LipiFlow treatment.

October 27, 2016:

2016 AAO Meeting: Glaucoma Sessions Light on Discussion of MIGS Technology

Much of the focus was on traditional glaucoma surgery treatments.

October 27, 2016:

2016 AAO Meeting: OIS Draws More than 900 Attendees

Allergan was selected as innovator of the year in a break with the group’s tradition of honoring an individual.

October 27, 2016:

Market Report: Retinal Pharma Market Continues to Climb; Competition Looms

The segment is expected to total $10.3 billion by 2021.

October 27, 2016:

Report: US Should Set Goal to Eliminate Correctable Vision Impairment by 2030

Authors say factors impeding vision health include segregation of eye care from the rest of medicine.

October 27, 2016:

Nicox’ AC-170 Fails to Gain FDA Approval Due to Concerns over Manufacturing

The France-based company said it has been contacting its suppliers to address the issue, and then it will resubmit its NDA.

October 27, 2016:

Gene-Editing Developer CRISPR Therapeutics Raises $56 Million in Initial Public Offering

The startup has partnered with Bayer to develop gene-editing cures for blindness and other diseases.

October 27, 2016:

FDA Workshop Looks at Study Design for Contact Lenses to Control Myopia

A panel that considered patient selection criteria concluded that subjects should be ages 7 to 12 with a refractive error of about -1.0D to -4.0D.

October 27, 2016:

Study: Use of Two iStents in Eye Shows Promise as Initial Treatment for Naive Glaucoma

Patients saw a 43 percent reduction in mean IOP—dropping from 25.5 mmHg to 14.6 mmHg—three years after implantation.

October 27, 2016:

Second Sight: First Human Implanted with Wireless Visual Cortex Stimulator

The patient was able to perceive individual spots of light with no significant adverse side effects.

October 27, 2016:

October 2016 News Briefs

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