Skip to main content

CYSTARAN

Generic: cysteamine hydrochloride

Verified·Apr 23, 2026
Manufacturer
Leadiant Biosciences
NDC
54482-020
RxCUI
1313780
Route
OPHTHALMIC
ICD-10 indication
E72.04

Affordability Check

How much will you actually pay for CYSTARAN?

In 30 seconds, see every legitimate way to afford CYSTARAN — Medicare copay, manufacturer copay card, Patient Assistance Program, grants, or cash.

Check my options →

About CYSTARAN

What is this medication?

Cystaran is a prescription ophthalmic solution used for the treatment of corneal cystine crystals in patients who have cystinosis. Cystinosis is a rare, life-long genetic disorder that leads to the buildup of the amino acid cystine in various organs and tissues, including the cornea of the eye. If these crystals are allowed to accumulate, they can cause significant eye pain, extreme sensitivity to light, and potential vision loss over time.

The medication contains the active ingredient cysteamine, which works by reducing the amount of cystine within the cells of the cornea. By lowering cystine levels, the drops help to dissolve existing crystals and prevent new ones from forming, thereby managing the ocular symptoms of the disease. Because the underlying condition is chronic, patients typically need to apply the drops frequently every day as part of a long-term treatment plan to maintain eye health.

Copay & patient assistance

  • Patient Copay Amount: Not Publicly Available
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Not Publicly Available
  • RxBIN, PCN, and Group numbers: Not Publicly Available

External links go directly to the manufacturer's portal. RxCopays does not receive compensation for referrals.

Compare pricing elsewhere

RxCopays doesn't sell drugs or take referral fees. Here are the transparent-pricing directories we recommend checking alongside your insurance formulary.

We deep-link because transparency helps patients. None of these partners pay RxCopays.

Prescribing information

From the FDA-approved label for CYSTARAN. Official source: DailyMed (NLM) · Label effective Apr 30, 2025

Indications and usage
1 INDICATIONS AND USAGE CYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. ( 1 )
Dosage and administration
2 DOSAGE AND ADMINISTRATION Instill one drop of CYSTARAN in each eye, every waking hour. Do not touch dropper tip to any surface, as this may contaminate the solution. Discard after 1 week of use. Instill one drop of CYSTARAN in each eye, every waking hour. ( 2 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Warnings and precautions
5 WARNINGS AND PRECAUTIONS To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. 5.2 Benign Intracranial Hypertension There have been reports of benign intracranial hypertension (or pseudotumor cerebri) associated with oral cysteamine treatment that has resolved with the addition of diuretic therapy. There have also been reports associated with ophthalmic use of cysteamine; however, all of these patients were on concurrent oral cysteamine. 5.3 Contact Lens Use CYSTARAN contains benzalkonium 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 [see Patient Counseling Information (17) ] . 5.4 Topical Ophthalmic Use CYSTARAN is for topical ophthalmic use.
Adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence approximately 10% or greater) are sensitivity to light, redness, eye pain/irritation, headache and visual field defects. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure in controlled clinical trials of six months to 19 years duration in approximately 300 patients. The most frequently reported ocular adverse reactions occurring in ≥10% of patients were sensitivity to light, redness, and eye pain/irritation, headache and visual field defects.
Use in pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well controlled studies of ophthalmic cysteamine in pregnant women to inform any drug associated risks. Oral administration of cysteamine to pregnant rats throughout the period of organogenesis was teratogenic at doses 86 to 345 times the recommended human ophthalmic dose (based on body surface area) [see Data ] . CYSTARAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data Teratology studies have been performed in rats at oral doses in the range of 37.5 mg/kg/day to 150 mg/kg/day (86 to 345 times the recommended human ophthalmic dose based on a body surface area) and have revealed cysteamine bitartrate to be teratogenic. Observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exencephaly, and growth deficits.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How CYSTARAN appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

70%

3,879 of 5,509 plans

Most common tier

Tier 5

On 83% of covering formularies

Prior authorization required

78%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)33
14%
Tier 2 (generic)2
1%
Tier 4 (non-preferred brand)4
2%
Tier 5 (specialty)195
83%
Tier 61
0%

Step therapy: 0% of formularies

Quantity limits: 37% of formularies

Coverage breadth: 235 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.

Rare-disease navigation (specialists, trials, patient communities)

CYSTARAN treats a rare condition. For in-depth disease pages on our sister site:

UniteRare.org is our sister site for rare-disease navigation — same editorial team, same accuracy standards.