Background: Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis (ARC), but a lack of robust evidence has deterred its use in North America.Objective: To determine the efficacy and tolerability of standardized glycerinated short ragweed sublingual allergen immunotherapy liquid (RW-SAIL) extract in subjects with ragweed-related ARC.Methods: This phase 3, randomized, placebo-controlled trial was conducted in North America. Subjects (age range, 18-55 years) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed. Subjects self-administered the maximum tolerated dose of RW-SAIL (n 5 218) or placebo (n 5 211) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season. The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores (TCS).Results: During the entire season, there was a 43% decrease in TCS in subjects treated with RW-SAIL compared with placebo. Similar decreases were observed in TCS between the 2 groups during peak season (42%) and in daily symptom scores during the entire (42%) and peak (41%) seasons. The occurrence of adverse events was similar between the treatment groups; most were mild in severity. Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited. No anaphylaxis occurred.Conclusions: This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual standardized ragweed allergen immunotherapy liquid extract for the treatment of ARC.

In this 8-week open-label, prospective study, 30 patients with grass pollen allergy and ocular itching instilled nedocromil sodium 2% ophthalmic solution twice daily for a 5-day baseline period, followed by once-daily dosing thereafter. Physicians assessed clinical signs after the twice-daily period and after weeks 1 and 3 of the once-daily period; patients rated ocular symptoms daily. Use of specified rescue medication was permitted. Symptom scores for ocular itching, stinging, redness, swelling, burning, tearing, and light sensitivity did not differ significantly between the dosage periods. Scores for erythema, edema, conjunctival injection, and the entire conjunctiva decreased slightly during once-daily administration; discharge scores were unchanged. Of the 20 patients who used rescue medication, only 5 increased their usage by more than two doses per week during the once-daily period. Eighty-three percent of patients were willing to continue the once-daily regimen during the next allergy season. Physicians rated overall control of seasonal allergic conjunctivitis with once-daily administration as "good" or "moderate" in 100% of the patients; 93% of patients applied those ratings themselves. Nedocromil sodium 2% ophthalmic solution instilled once daily maintains control of symptoms in patients who are established on a twice-daily regimen.

To evaluate nedocromil sodium 2% ophthalmic solution for the treatment of seasonal allergic conjunctivitis, 24 golfers with documented ragweed-pollen allergy instilled eyedrops twice daily for 4 days prior to golf-course intervention and 15 minutes before playing a round of golf during peak ragweed season. Ocular symptoms were scored at baseline (7 days before golfing), prior to instillation on the day of golf, and 30 minutes, and 1, 4, 8, and 12 hours after tee-off. Physician assessment was performed prior to tee-off, before tee-off on the ninth hole, and at the end of the 18th hole. Itching, burning, grittiness, tearing, redness, and light sensitivity were significantly decreased after nedocromil administration, as were erythema, edema, conjunctival hyperemia, and overall findings in the conjunctiva. Symptom severity scores fell approximately 30 minutes after instillation, with improvements persisting 8 and 12 hours after treatment. Most patients (92%) rated the treatment moderately or completely effective, and 83% were willing to continue its use. Physician assessments of effectiveness agreed with those of the patients. In this open-label study, nedocromil sodium eyedrops relieved the ocular symptoms of seasonal allergic conjunctivitis for up to 12 hours, well beyond a usual round of golf.

In this 2-week, randomized, crossover study, ophthalmic solutions of nedocromil sodium 2% and olopatadine hydrochloride 0.1% were compared for effectiveness and acceptability in 28 patients with perennial allergic conjunctivitis and previous olopatadine experience. Patients received nedocromil twice daily or olopatadine twice daily for 1 week, then were crossed over to the alternate medication for 1 week. Outcome measures were patient satisfaction (questionnaire), severity of ocular symptoms (daily diary scores), clinical signs (physician assessments), quality of life (questionnaire), and global assessments of effectiveness. Both medications were well accepted. Of the 28 patients, 16 (57.1%) would request a nedocromil prescription, 10 (35.7%) an olopatadine prescription (P = .157); 22 patients (78.6%) would recommend nedocromil to other allergy sufferers, while 18 (64.3%) would recommend olopatadine (P = .480). Light sensitivity scores were significantly lower with nedocromil (P = .0125); other symptom scores were comparable between medications. Both drugs significantly (P < .01) and comparably decreased erythema, conjunctival injection, and overall conjunctival signs from baseline. Comparable improvement also occurred in quality-of-life scores. Both physicians and patients judged nedocromil and olopatadine to be similarly effective in preventing signs and symptoms. Nedocromil sodium 2% is an effective treatment for perennial allergic conjunctivitis. Patients receiving olopatadine can be switched to nedocromil with no loss in efficacy or satisfaction, but with a reduction in cost.

This double-masked, comparative, multicenter study was conducted to assess the onset of action and tolerability of nedocromil sodium 2% ophthalmic solution BID, 60-mg terfenadine tablets BID, and placebo in the treatment of seasonal allergic conjunctivitis. Two hundred sixty-eight patients in whom seasonal allergic conjunctivitis was diagnosed were assigned to 1 of 3 groups and administered study medication for 4 weeks. Patients' mean age was 33 years (range, 12 to 68 years); 57.8% (155 of 268) were female. Demographic characteristics were similar in all 3 groups. Although all 3 groups showed improvement in ocular symptoms, nedocromil sodium was associated with a statistically significantly faster onset of action than was terfenadine or placebo (P = 0.038). During the study, 29 nedocromil sodium-treated patients (36.7%) achieved control of symptoms in < or =2 minutes, and 61 (77.2%) achieved control in < or =15 minutes. The corresponding numbers were 21 (24.7%) and 50 (58.8%) in the terfenadine group and 25 (29.1%) and 48 (55.8%) in the placebo group. The frequency of adverse events was low and similar between groups (nedocromil sodium, 26; terfenadine, 32; placebo, 32). No severe treatment-related adverse events were reported. In conclusion, nedocromil sodium had a significantly faster onset of action than did terfenadine or placebo.