Eye performance for the treatment of cysteine deposition FDA approved the first cysteine eye drops.

Recordati Rare Diseases recently announced that the U.S. Food and Drug Administration (FDA) has approved Cystadrops (cysteine eye drops, 0.37 percent).
Cystadrops is a new viscous eye drop that consumes cysteine crystal deposits in the corneas of patients with cystinosis.
Cystadrops significantly reduces cysteine crystal deposition in the cornea of the eye and is the first and only FDA-approved cysteine eye dropr, given four times a day.
is a rare congenital disease that causes cysteine crystals to accumulate throughout the body, causing extensive tissue and organ damage and significant effects on the eyes.
, chief executive of Recordati, said: "People with cysteine storage and their caregivers manage multiple medications every day.
to ease their daily burden, Recordati is working to develop a new formula for viscous eyedrings for the treatment of corneal cysteine crystals.
We are pleased to bring Cystadrops products to patients in the United States, the first FDA-approved cysteine eye drops formula that is actually used four times a day to reduce corneal crystals.
Clinton Moore, president of the Cystinosis Research Network, said: "Cysteine storage is a complex disease and early detection and timely treatment are critical to slowing the development and progression of symptoms.
improvements in treatment for cysteine storage have led to an increase in life expectancy over the past few decades.
despite these advances, the eye manifestations of the disease are an ongoing struggle for patients.
people with cysteine storage are sensitive to light, eye discomfort and pain.
often wear sunglasses even indoors, trying to keep up with everyday activities such as school and work.
" Cystadrops is a sticky or viscous, cysteine-consuming eye solution used to treat corneal cysteine crystal deposition in adults and children with cysteine storage disorders.
is a complex and rare disease that requires patients and caregivers to use many different medications every day.
Cystadrops is the first and only FDA-approved cysteine eye drop formula to be used four times a day while awake.
Cystadrops can be stored at room temperature for up to 7 days after opening.
FDA's approval of Cystadrops was supported by data from two clinical trials.
patients in both clinical trials were treated with Cystadrops at a medium frequency of 4 times a day.
- In phase 3 open-label, randomized, controlled, two-arm multi-center trials, Cystadrops group had 15 patients who were studied using a living confocus microscope (IVCM) to assess the decrease in the crystal density of corneal cysteine.
data showed that the total IVCM score for all cornea layers was reduced by 40 percent in the Cystadrops group from baseline to day 90 of treatment.
- In phase 1/2a open-label, adaptive dose response clinical trials, 8 patients were treated with Cystadrops.
showed that the overall IVCM score of patients was reduced by 30% and could be maintained over a five-year study period.
safety of Cystadrops was evaluated in two clinical trials.
The most common adverse reactions are pain in the eyes (tingling), blurred vision, eye irritation (burning), redness of the eyes, discomfort with the eye drops (sticky eyes or sticky eyelids), itching of the eyes, watery eyes, eyelashes or drug deposits around the eyes.
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