Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)

Inclusion Criteria

• •Male and female subjects must have completed the last visit of Study RP103-03 and be willing to continue with RP103 treatment.
• •OR for patients who did not complete the RP103-03 study:
• •Male and female subjects must have cystinosis.
• •Subjects must be on a stable dose of Cystagon® at least 21 days prior to Screening.
• •Within the last 6 months, no clinically significant change from normal in liver function tests (i.e., alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], total bilirubin) and renal function (i.e., estimated glomerular filtration rate \[eGFR\]) at Screening as determined by the Investigator.
• •Subjects with an eGFR corrected for body surface area \> 30 mL/min/1.73m².
• •Sexually active female subjects of childbearing potential (i.e., not surgically sterile \[tubal ligation, hysterectomy, or bilateral oophorectomy\] or at least 2 years naturally postmenopausal) must agree to utilize the same acceptable form of contraception from Screening through completion of the study.
• •Subjects must be willing and able to comply with the study restrictions and requirements.
• •Subjects or their parent or guardian must provide written informed consent and assent (where applicable) prior to participation in the study.