For US Audiences Only
FOR U.S. HEALTHCARE PROFESSIONALS
FOR U.S. PATIENTS
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IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION | INSTRUCTIONS FOR USE

MEDICAL INFORMATION | REPORT AN ADVERSE EVENT

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CYSTADROPS DISSOLVES CYSTINE CRYSTALS ACROSS ALL LAYERS OF THE CORNEA

CYSTADROPS is the first and only viscous ophthalmic solution with practical, 4 times a day dosing for the depletion of corneal cystine crystals1

CYSTADROPS contains 0.37% of cysteamine (equivalent to 0.55% cysteamine hydrochloride). CYSTADROPS is formulated with carmellose sodium for greater viscosity.1

Viscous cysteamine coats the cornea allowing the active ingredient to penetrate the cornea cells. The cysteamine converts cystine to cysteine and cysteine-cysteamine mixed disulfides which can then exit the lysosome. As a result, corneal cystine crystal accumulation is reduced in all layers of the cornea with continued use.1,2

Cystadrops contains benzalonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.1


How CYSTADROPS Works

CYSTADROPS EFFICACY

CYSTADROPS DEMONSTRATED A SIGNIFICANT REDUCTION IN CORNEAL CYSTINE CRYSTAL DEPOSITS WITH 4X/DAY DOSING1,2

  • The average reduction in IVCM total score was 4.6 in the CYSTADROPS arm and 0.5 in the control arm,
    mean difference 3.8 (95% CI; p<0.0001)1,2

IVCM TOTAL SCORE REDUCTION FROM BASELINE2,5

Cystine eye drops clinical data

CYSTADROPS DECREASED CYSTINE CRYSTALS IN ALL LAYERS OF THE CORNEA AS MEASURED BY IVCM TOTAL SCORE1,2

IVCM SCORE IN EACH LAYER OF THE CORNEA AT DAY 1, DAY 30, AND DAY 902

Cystine eye drops clinical data

CRYSTAL DENSITY ASSESSMENT:

  • Each layer of the cornea was graded on a scale from 0 to 43
  • Higher scores designated larger amounts of crystal deposits; a decrease in IVCM total score indicated a reduction in corneal crystals3
  • IVCM score was assessed for each layer of the eye at day 1 (baseline), day 30, and day 902

CYSTADROPS MAINTAINED EFFICACY OVER 5 YEARS1,5

Cystine eye drops clinical data

CYSTADROPS SAFETY PROFILE1

The most common adverse reactions (≥ 10%) reported during clinical trials were:

  • Eye pain
  • Vision blurred
  • Eye irritation
  • Ocular hyperaemia
  • Instillation site discomfort
  • Eye pruritus
  • Lacrimation increased
  • Ocular deposits

CONTACT AN RRD REPRESENTATIVE

To learn more about CYSTADROPS, schedule an appointment with a Recordati Rare Diseases representative.

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Dosing & Administration

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Indications and Usage

CYSTADROPS (cysteamine ophthalmic solution) 0.37% is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

Important Safety Information

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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Important Safety Information

  • To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use.

References

  1. CYSTADROPS [Package Insert]. Lebanon, NJ: Recordati Rare Diseases; 2020
  2. Liang H, Labbé A, Le Mouhaer J, Plisson C, Baudouin C. A new viscous cysteamine eye drops treatment for ophthalmic cystinosis: an open-label randomized comparative phase III pivotal study. Invest Ophthalmol Vis Sci. 2017;58(4):2275-2283. doi: 10.1167/iovs.16-21080
  3. Liang H, Baudouin C, Hassani RTJ, Brignole-Baudouin F, Labbé A. Photophobia and corneal crystal density in nephropathic cystinosis: an in vivo confocal microscopy and anterior-segment optical coherence tomography study. Invest Ophthalmol Vis Sci. 2015:56(5):3218-3225. doi: 10.1167/iovs.15-16499
  4. Labbé A, Baudouin C, Deschenes G, Loirat C, Charbit M, Guest G, Niaudet P. A new gel formulation of topical cysteamine for the treatment of corneal cystine crystals in cystinosis: the Cystadrops OCT-1 study. Mol Genet Metab. 2014;111(3):314-320. doi: 10.1016/j.ymgme.2013.12.298
  5. Recordati Rare Diseases Inc., data on file, 2020