Alocril®
nedocromil 2.0% · ophthalmic solution
Allergy
Approved uses
Ocular itching in allergic conjunctivitis
1 or 2 drops in each eye BID, continued through the allergen exposure period
Slower to act than an antihistamine, so it is dosed as maintenance rather than rescue for acute itch.
OFF-LABELNot in the FDA label for this product
Vernal keratoconjunctivitis
1 drop in each eye QID, above the labeled BID frequency; the trial ran 5 months
RCT · n=36 · single-masked
Investigator single-masked randomized trial in children aged 4 to 17 with mostly limbal disease, 18 per arm and 34 completing, against sodium cromoglycate 2% QID for 5 months. Effect came on faster, with significant separation for itching, grittiness, hyperemia, and keratitis by 6 weeks and superiority for hyperemia, keratitis, papillae, and pannus at 22 weeks; full control was recorded for 94% by patient opinion and 100% by clinician opinion versus 29% and 0% on cromoglycate. Weak design: small, no placebo arm, single-masked, and rescue dexamethasone was permitted.
Perennial allergic conjunctivitis at QID dosing
1 drop in each eye QID, above the labeled BID frequency
Pooled analysis · sponsor data
Pooled statistical overview of the manufacturer's double-masked placebo-controlled program: in perennial disease QID (n=146) outperformed BID (n=86), and QID controlled 72% of patients versus 47% on placebo (n=156, p<0.001), while BID was adequate for seasonal disease. Evidence is a sponsor overview of pooled European trials of the same 2% solution, not an independent randomized trial, so treat the QID escalation as reasonable rather than proven.
Contraindications
Hypersensitivity to nedocromil sodium or to any other ingredient in the formulation.
Available FormsOphthalmic solution, nedocromil sodium 2% (20 mg/mL), 5 mL fill in a 10 mL opaque LDPE dropper bottle
Mechanism of ActionMast cell stabilizer: inhibits release of mediators from cells involved in hypersensitivity reactions, and decreases eosinophil chemotaxis and activation. Benefit comes from preventing mediator release rather than blocking mediator already released, so it is prophylactic; the label directs dosing at regular intervals throughout allergen exposure even when symptoms are absent.
Warnings & Precautions
- Contact lenses: Should not be worn during treatment, or while signs and symptoms of allergic conjunctivitis are present; preserved with benzalkonium chloride 0.01%.
- Tip contamination: Keep the dropper tip off the eye, surrounding structures, fingers, and any other surface; contaminated solution has caused serious ocular damage and vision loss.
Common Side Effects
- Ocular: Burning, irritation, and stinging in 10% to 30%; eye redness, conjunctivitis, and photophobia in 1% to 10%, some overlapping with the underlying allergic disease.
- Systemic: Headache in about 40%, the most frequent event reported; unpleasant taste and nasal congestion in 10% to 30%; asthma and rhinitis in 1% to 10%.
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women; subcutaneous doses in mice, rats, and rabbits more than 1600 times the maximum human daily ocular dose showed no teratogenicity or fetal harm. Use only if clearly needed.
Lactation: Excreted in the milk of lactating rats after IV dosing; excretion in human milk is unknown.
Pediatric UseSafety and effectiveness below age 3 not established.