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Executive Summary

DEL LABS WILL REDESIGN SYTE YELLOW MERCURIC OXIDE BLEPHARITIS PROTOCOL and may include the use of "eyelid scrubs." Del agreed to redesign its September 1991 proposed protocol for a study of yellow mercuric oxide (YMO) 1% ophthalmic ointment as an OTC blepharitis (inflamed eyelids) treatment at the conclusion of an OTC "feedback" meeting with FDA on March 31. No final conclusions were reached by the company and FDA about what form the revised protocol will take and Del indicated that it may meet with the agency again for further feedback. Del's Commerce Drug Co. currently markets Stye (YMO 1%) ointment and is the only company actively pursuing the inclusion of YMO in the final monograph for OTC ophthalmic drug products, FDA said. Published March 4, 1988, the final monograph did not discuss ophthalmic anti-infectives due to "complex scientific issues" that had to be resolved, among them the efficacy of YMO ("The Pink Sheet" March 7, 1988, p. 6). Del first submitted data seeking YMO's approval for OTC blepharitis treatment in 1984. FDA told Del in August 1989 that three clinical trials submitted on YMO effectiveness against blepharitis were inadequate to support a Category I designation ("The Pink Sheet" March 12, 1990, T&G-16). A Jan. 27 letter from FDA Division of OTC Drug Evaluation Director William Gilbertson states: "For an ingredient to demonstrate safety and effectiveness for the treatment of blepharitis, it must be shown that the ingredient is better than treatment with eyelid scrubs plus placebo." Del's protocol called for a two-arm trial -- placebo and YMO -- but no scrubs. Scott Davis, president of Pharmaceutical Development Associates, which will perform the clinical trial for Del, noted that the protocol uses "scaling and exudation" of the eyelid as primary efficacy parameters. "If we use [a scrub] that mechanically removes those two things [from the blepharitic eyelid], you bias the study in such a way that it is impossible to show a statistically significant difference in those two parameters," he contended at the feedback meeting. Del also objected to using scrubs because they are "an active control you don't even know the efficacy of," outside counsel Nancy Buc (Washington, D.C. firm Weil, Gotshal & Manges) said. Buc wrote FDA Feb. 10 that the trial should reflect how the product will be used over the counter, arguing that "persons using the drug in real life will presumably not be under a physician's care ...and therefore will probably not be using eyelid scrubs." FDA Division of OTC Drug Evaluation Deputy Director Gerald Rachanow said: "The way we [the OTC Division] thought this product might eventually wind up on the OTC market was with a package with a lid scrub...It would be marketed with the type of labeling saying do not use this product unless recommended by a doctor... Sort of the same idea that the agency had in the treatment of products for vaginal yeast infections." Another argument for including eyelid scrubs in the trial design was raised by FDA Division of Medical Imaging, Surgical and Dental Products Director Wiley Chambers, MD. He said FDA is "concerned" that the vehicle used in a YMO ointment "is going to make the condition worse unless it is periodically removed." Del consultant Lewis Groden, MD, University of South Florida, said, "I don't think there is any article that says that." Chambers said his information was taken from confidential clinical trials, adding "I don't know if I have evidence that I can share with you." Chambers proposed that the company design a protocol with three arms: placebo with eyescrubs, YMO with eyescrubs, and YMO alone. He pointed out that if either the YMO with lidscrubs or the YMO alone was better than the placebo with lidscrubs, the trial could show the efficacy of YMO. "You have two different ways to beat this," he said. Davis said he had "concerns about being able to show efficacy" with this design. Buc noted that adding trial arms "gets more expensive and you need more patients." Del's proposed protocol involves 300 patients in a one-week treatment period followed by one week of follow-up.

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