This article is more than 5 years old. Information may no longer be current.
Study: Alamast combats allergic conjunctivitis with little pain
Santen’s first new product in the United States, Alamast has shown results beyond expectations.
Click Here to Manage Email Alerts
FORT LAUDERDALE, Fla. — Santen Pharmaceutical’s (Osaka, Japan) first product released in the United States greatly exceeded the expectations of its designers and clinical investigators with its ability to quell and prevent allergic conjunctivitis.
Alamast, made up of 0.1% pemirolast potassium ophthalmic solution, is a mast cell stabilizer that works by inhibiting the in vivo type 1 immediate hypersensitivity reaction. It also inhibits the antigen-induced release of inflammatory mediators such as histamines and leukotrienes C4, D4 and E4 from human mast cells. Alamast also inhibits the chemotaxis of eosinophils.
“Allergic conjunctivitis is the most common form of ophthalmic allergy. Patients are usually frustrated with the chronic conditions of the allergy and the variety of medicinal approaches. Alamast is different because it’s preventative,” according to clinical investigator Gregg J. Berdy, MD, who presented findings at the annual meeting of the Association for Research and Vision in Ophthalmology.
Before and after allergy season
Alamast was tested in a double-masked, parallel group study that showed it was statistically significant when compared with a placebo. The groups consisted of 134 patients in the Alamast group and 131 in the placebo group. They were studied pre-allergy season, during the season and post-allergy season and were asked to keep daily journals where they rated itching and redness.
Patients chosen for the study had a history of allergic conjunctivitis, a positive skin prick response for ragweed and a positive bilateral response to a pre-season conjunctival allergen challenge test.
On day 0, the subjects were tested. Day 1 they were given their first drops, 10 days before the start of allergy season. For the next 12 to 17 weeks, the patients used the drops, and they also used them for 5 to 30 days after allergy season. The diary data was examined by 7-day and 14-day periods.
According Dr. Berdy, the Alamast study was helped by a very severe and extended allergy season. The study was done in the St. Louis area in 1997 during a particularly dry season.
During the post-season allergen challenge test, Alamast showed lower incidences of itching than the placebo. In all clinical trials with Alamast, there was only a 1% incidence of burning or stinging. “It’s a very comfortable drop,” Dr. Berdy said.
Alamast was not shown to be significantly different than the placebo for adverse events, visual acuity, biomicroscopy or intraocular pressure. The most commonly reported ocular adverse events were foreign body sensation (2%), burning/stinging (1%), dry eye (1%) and ocular discomfort (1%).
The clear future of Alamast
The company and investigators suggest that Alamast’s role in therapy will be for use with people suffering from chronic, recurring allergic symptoms, those needing prolonged treatment, those seeking a more comfortable alternative and for children as young as age 3.
According to Adrienne Graves, PhD, the most important aspects of the study was that it took place in a real-world environment. The study proved that it was effective as early as the first week, it had a sustained preventative aspect, it was safe and it offered superior comfort. “Comfort is very important to compliance and efficacy. If it hurts less, people will continue to take it.”
Dr. Berdy also pointed out that this is the first mast cell stabilizer approved for prevention.
Santen announced it has other products in the pipeline as well, including drugs for ocular infection, glaucoma and dry eye.
For Your Information:
- Gregg J. Berdy, MD, can be reached at 456 N. Ballas Rd., Ste. 386, Creve Coeur, MO 63141; (314) 993-5000; fax: (314) 993-5558. Dr. Berdy has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.
- Adrienne Graves, PhD, can be reached at Santen Inc., 555 Gateway Dr., Napa, CA 94558; (707) 254-1750; fax: (707) 254-3648. Dr. Graves is vice president of worldwide clinical development at Santen.