Saturday, February 22, 2020

FDA Approves First Contact Lens Indicated to Slow Progression of Myopia in Children

The FDA approved the first contact lens indicated to slow the progression of myopia in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens made by CooperVision is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.
When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.
The trial showed that for the full 3-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. 
Three-year peer-reviewed results published in Optometry and Vision Science in August 2019 indicated that use of MiSight 1 day was shown to slow myopia progression 59%.
Generally, myopia first occurs in school-age children and progresses until about age 20.   41.9% of U.S. children ages 5-19 are myopic.9 This is due in part to changing lifestyles, with children spending less time outdoors and more time spent focusing on close objects such as digital screens.
MiSight 1 day will launch in the United States as part of a CooperVision myopia management initiative beginning in March 2020. 

FDA Approves First Treatment for Thyroid Eye Disease

The FDA approved Horizon Therapeutics’ Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease (TED). The approval represents the first drug approved for the treatment of thyroid eye disease.  
This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non‑surgical treatment option.
Tepezza is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions.
We expect the average net realized price for a 6-month course of therapy for Tepezza to be approximate $200,000. 
Tepezza was approved based on the results of two studies (Study 1 and 2) consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo. Of the patients who were administered Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2 millimeter reduction in proptosis (eye protrusion) as compared to 20% and 10% of subjects who received placebo, respectively.
The most common adverse reactions observed in patients treated with Tepezza are muscle spasm, nausea, alopecia (hair loss), diarrhea, fatigue, hyperglycemia (high blood sugar), hearing loss, dry skin, dysgeusia (altered sense of taste) and headache. Tepezza should not be used if pregnant.

affronEYE® Saffron Extract May Lower Risk of Glaucoma

A new animal study suggests affronEYE saffron could help prevent the onset of glaucoma. The antioxidant and anti-inflammatory characteristics of this potent saffron extract, developed by Pharmactive Biotech Products, S.L., demonstrated an ability to protect retinal cells from damage and death and reduce intraocular hypertension — a key aspect of glaucoma development. 
The study, published in the International Journal of Molecular Sciences on August 2019, demonstrated the neuroprotective and anti-inflammatory effects of Pharmactive’s proprietary hydrophilic saffron extract.
After treatment with AffronEYE, the number of living retinal ganglion cells in the treated group was significantly higher in comparison to the non-treated group. 
AffronEYE’s activities are attributed to its naturally occurring bioactive compounds, specifically crocinsand crocetins. These carotenoids are reported to possess a full spectrum of anti-inflammatory, antioxidative, and neuroprotective properties through their ability to scavenge free oxygen radicals, thus reducing retinal cell damage and cellular self-destruction.
 “Crocins significantly increase the blood flow in the retina,” Mr. Espinel said. “They are believed to improve oxygenation and nutrient supply to retinal structures, serving to slow or completely prevent the development of glaucoma.”


February 2020 - The FDA has granted CooperVision approval for its new Biofinity toric multifocal contact lenses. The product combines the optical designs of CooperVision’s Biofinity toric—the most prescribed toric lens on the market1—and Biofinity multifocal to provide patients with astigmatism and presbyopia vision correction. The company plans to make the lenses available to US eye care professionals later this year, followed by other markets. Lens parameters and other details regarding Biofinity toric multifocal will be made public in the coming months.
This is a huge deal!  Biofinity toric is considered the most stable toric contact lens.  And Biofinity Multifocal provides low, medium, and high adds in either a center distance or center near design.  This lens should be a game changer. 


Alcon announced that Pataday Once Daily Relief (olopatadine hydrochloride ophthalmic solution 0.2%) and Pataday Twice Daily Relief (olopatadine hydrochloride ophthalmic solution 0.1%) have been approved by the FDA for sale over-the-counter (OTC) in the United States. 
Pataday Once Daily Relief and Pataday Twice Daily Relief are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander for ages 2 and older. Pataday Twice Daily Relief is also indicated for the temporary relief of red eyes. Since 2008, over 40 million prescriptions have been written for olopatadine, the active ingredient in Pataday.
U.S. commercial availability of Pataday Once Daily Relief and Pataday Twice Daily Relief will begin March 2 in time for the start of spring allergy season, and will be available in all major drug, food and mass market retailers, as well as through online retailers.