FDA BRIEF: Week of July 11, 2016

FDA approved

 

EXABLATE NEURO

InSightec, Dallas, TX, USA

INDICATION FOR USE: In patients with essential tremor whose tremors cannot be treated using medication. Patients must be at least 22 years old. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the ExAblate device.

UNMET NEED:

  • Essential tremor, also called benign essential tremor, is the most common form of tremor
  • Several million Americans, usually those over age 40, are affected by the condition
  • If medications fail, treatment with surgery (thalamotomy) or deep brain stimulation to destroy thalamus that controls some involuntary movements.
  • Need for new treatment option that could help them to avoid more invasive surgical treatments

REG PATHWAY: PMA

DEVICE DESCRIPTION:

  • Magnetic resonance image-guided focused ultrasound (MRgFUS) system
  • Non-invasively destroys tiny areas of brain tissue
  • The ultrasound treatment applied in incremental increases in energy called sonications until  satisfactory result is achieved

EFFECTIVENESS:

  • Double-blind control trial (n=76) patients with essential tremor, not responded to medication therapy
  • ExAblate Neuro treatment vs. fake treatment (crossed over to treatment group after 3 mo.)
  •  3 mo post-procedure. : 50 % improvement tremors and motor function (composite tremor/motor function score) vs. no improvement/ slight worsening
  • 12 mo post-procedure : 40%  percent improvement compared to baseline.

SAFETY:

  • Adverse events consistent with thalamotomy surgery: Numbness/tingling of  fingers, headache, imbalance/unsteadiness, loss of control of body movements (ataxia) or gait disturbance
  • Other effects possibly related to MR-guided focused ultrasound treatment: Tissue damage in an area other than the treatment area, hemorrhage in the treated area requiring emergency treatment, skin burns with ulceration of the skin, skin retraction and scar formation and blood clots.

CONSUMER INFORMATION


XIIDRA (lifitegrast)  ophthalmic solution 

 Shire, Lexington, MA, USA

INDICATION:  Treatment of the signs and symptoms of dry eye disease (DED).

UNMET NEED:

  • DED  – Eye does not produce adequate tear volume or tears are not of correct consistency
  • ~ 5% population (age 30-40), 10-15% (age >65); more common in women
  • Can lead to pain, ulcers or scars in cornea
  • Need for new treatment option

REG PATHWAY: NDA, Standard review

MECHANISM OF ACTION:

  • Binds to the integrin lymphocyte function-associated antigen-1 (LFA-1) with cognate ligand intercellular adhesion molecule-1 (ICAM-1)
  • ICAM-1 may be overexpressed in DED

EFFICACY:

  • Four  12-week, randomized, multi-center, double-masked, vehicle-controlled studies (n=1181); minimal signs (i.e., Corneal Fluorescein Staining (CFS) and non-anesthetized Schirmer Tear Test (STT)) and symptoms (i.e., Eye Dryness Score (EDS) and Ocular Discomfort Score (ODS)) severity scores at baseline
  • DED Symptoms:  Eye dryness Score (EDS) using visual analogue scale (VAS);  larger EDS reduction with Xiidra
  • DED Signs:  Dry Eye Disease Inferior fluorescein corneal staining score (ICSS); larger reduction in ICSS favoring Xiidra

SAFETY: Most common side effects: Eye irritation, discomfort or blurred vision, unusual taste sensation (dysgeusia).

LABEL


TECNIS SYMFONY IntrOcular Lens (IOL)

Abbott Medical Optics, Santa Ana, CA, USA

INDICATION FOR USE: For  cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.

UNMET NEED:

  • >20 %  Americans will have cataracts by  age  65
  • IOLs mainstay of cataract treatment
  • Need for new option for better vision across a broader range of distances

DEVICE DESCRIPTION: 4 toric models, reduction of residual refractive astigmatism or imperfections in the curvature of the eye

EFFECTIVENESS:

  • Randomized clinical trial comparing (n=200) , Tecnis Symfony IOL vs.  monofocal IOL
  • Endpoints: Visual acuity at near, intermediate and far ranges, contrast sensitivity
  • Intermediate distance: 77 % with good vision (20/25) vs. 34%
  • Near distance : Read two additional, progressively smaller lines with Tecnis
  • Distance vision: Comparable

SAFETY: Worsening of or blurred vision, bleeding or infection.


HUMULIN R U-500 insulin dedicated SYRINGE

SUMMARY:

  • Humulin R U-500 insulin vial has been available with no dedicated device for delivery since 1994
  • Dedicated syringe for the administration of Humulin R U-500 insulin
  • Only device approved for use with U-500 insulin vial
  • Humulin R U-500 insulin vial label will be updated to remove the dose conversion information for U-100 and tuberculin syringes

 

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