CyPass recall tops 2018 ophthalmology news

Alcon voluntarily recalled the CyPass micro-stent in October, citing safety data from a 5-year study showing significant endothelial loss. The article was the most-read ophthalmology story of 2018 on Healio.com/OSN.

Here is the list of the year’s top 10 stories:

 

Alcon calls for surgeons to stop implanting CyPass micro-stent

The decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone. Read more.

 

ReVision Optics goes out of business

ReVision Optics, maker of the Raindrop near vision inlay, has folded. Read more.

 

FDA approves Oxervate, the first drug to treat neurotrophic keratitis

Oxervate, cenegermin, developed by Dompé farmaceutici SpA, is the first FDA approved drug for the rare disease, which can cause loss of corneal sensation and impair corneal health. Patients with neurotrophic keratitis can experience corneal thinning, ulceration, and perforation in severe cases. Read more.

 

Xelpros gains FDA approval for open-angle glaucoma, ocular hypertension

Xelpros, latanoprost ophthalmic solution 0.005%, is the first latanoprost product not formulated with the preservative benzalkonium chloride and was developed with SPARC’s Swollen Micelle Microemulsion technology. Read more.

 

Near VA improves with topical presbyopia treatment

The PRX ophthalmic solution from Presbyopia Therapies LLC demonstrated a statistically significant three line or greater improvement in monocular distance corrected near visual acuity in a phase 2b trial, meeting primary efficacy and safety endpoints. Read more.

 

FDA approves ReLEx SMILE for myopia with astigmatism

The procedure, which is performed with the VisuMax femtosecond laser, may be potentially less disruptive to corneal surface tissue due to a small entry incision. Read more.

 

Reimbursement changes far reaching in 2018

Changes in CMS reimbursement affected many of the ophthalmic subspecialties this year. Important for cataract surgery was the expiration of the pass-through status for Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros). Read more.

 

Hundreds of clinics in US offering stem cell therapies without FDA approval

A cross-sectional, clinical study of stem cell therapy clinics found 40 companies with 76 clinics across the United States offering patients non-FDA approved “cell therapy” for ocular conditions. Read more.

 

Early follow-up after Xen implantation needed

Nearly 80% of patients who received a Xen gel stent with IOP-lowering topical medication after surgery experienced an IOP of less than 18 mm Hg, but early interventions were needed in 20% of patients. Read more.

 

FDA approves Dexycu to treat cataract surgery inflammation

Icon Bioscience reported the FDA approved its new drug application for Dexycu, a dropless therapeutic designed to treat inflammation associated with cataract surgery. Read more.

Alcon voluntarily recalled the CyPass micro-stent in October, citing safety data from a 5-year study showing significant endothelial loss. The article was the most-read ophthalmology story of 2018 on Healio.com/OSN.

Here is the list of the year’s top 10 stories:

 

Alcon calls for surgeons to stop implanting CyPass micro-stent

The decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone. Read more.

 

ReVision Optics goes out of business

ReVision Optics, maker of the Raindrop near vision inlay, has folded. Read more.

 

FDA approves Oxervate, the first drug to treat neurotrophic keratitis

Oxervate, cenegermin, developed by Dompé farmaceutici SpA, is the first FDA approved drug for the rare disease, which can cause loss of corneal sensation and impair corneal health. Patients with neurotrophic keratitis can experience corneal thinning, ulceration, and perforation in severe cases. Read more.

 

Xelpros gains FDA approval for open-angle glaucoma, ocular hypertension

Xelpros, latanoprost ophthalmic solution 0.005%, is the first latanoprost product not formulated with the preservative benzalkonium chloride and was developed with SPARC’s Swollen Micelle Microemulsion technology. Read more.

 

Near VA improves with topical presbyopia treatment

The PRX ophthalmic solution from Presbyopia Therapies LLC demonstrated a statistically significant three line or greater improvement in monocular distance corrected near visual acuity in a phase 2b trial, meeting primary efficacy and safety endpoints. Read more.

 

FDA approves ReLEx SMILE for myopia with astigmatism

The procedure, which is performed with the VisuMax femtosecond laser, may be potentially less disruptive to corneal surface tissue due to a small entry incision. Read more.

 

Reimbursement changes far reaching in 2018

Changes in CMS reimbursement affected many of the ophthalmic subspecialties this year. Important for cataract surgery was the expiration of the pass-through status for Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros). Read more.

 

Hundreds of clinics in US offering stem cell therapies without FDA approval

A cross-sectional, clinical study of stem cell therapy clinics found 40 companies with 76 clinics across the United States offering patients non-FDA approved “cell therapy” for ocular conditions. Read more.

 

Early follow-up after Xen implantation needed

Nearly 80% of patients who received a Xen gel stent with IOP-lowering topical medication after surgery experienced an IOP of less than 18 mm Hg, but early interventions were needed in 20% of patients. Read more.

 

FDA approves Dexycu to treat cataract surgery inflammation

Icon Bioscience reported the FDA approved its new drug application for Dexycu, a dropless therapeutic designed to treat inflammation associated with cataract surgery. Read more.