ALLERGAN WILL RESUBMIT OCUFEN CYSTOID MACULAR EDEMA DATA TO FDA

ALLERGAN WILL RESUBMIT OCUFEN CYSTOID MACULAR EDEMA DATA TO FDA "within the next 30 to 45 days" following the completion of a new analysis of the data, Allergan President William Shepard told financial analysts at Hambrecht & Quist's Life Sciences Conference in San Francisco Jan. 12. The FDA Anti-Infective Drugs Advisory Committee's Subcommittee on Ophthalmic Drugs recommended against approval of Ocufen (flurbiprofen .03%) eye drops for the supplemental indication of prevention of postoperative cystoid macular edema on Oct. 27 ("The Pink Sheet" Nov. 2, 1992, p. 6). Committee members commented on Ocufen's effectiveness in preventing CME, but they asked for additional analysis of the 16.5% of patients who dropped out of the clinical trials. Shepard confirmed that Allergan had "received a turn down letter from the FDA" for the indication. However, he said that Allergan met with FDA Jan. 12 to discuss the status of the supplemental NDA for Ocufen and "we believe that data we currently have, with some additional analysis will suffice for the FDA." With over 1 mil. cataract operations performed every year, the added indication would provide a much larger market potential for Ocufen than its current approved indication for short-term use to reduce intraoperative myosis. The company's ophthalmic quinolone Ocuflox (ofloxacin eye drops), licensed from Daiichi and Santen, reached the "approvable" stage at FDA Dec. 30 "subject to a plant inspection" by the agency, Shepard told the investment conference. Allergan said it is in discussions with FDA over the exact indication for Ocuflox. The NDA for the anti-infective was submitted in January 1989. Updating analysts on Allergan's Acular (ketorolac eye drops), Shepard said the company is shipping the treatment for ocular itching due to seasonal allergic conjunctivitis "this month" and will begin detailing the product to doctors "the first of March." Allergan gained agency approval for the ophthalmic formulation of the nonsteroidal anti-inflammatory drug in November ("The Pink Sheet" Nov. 16, 1992, In Brief). The oral and IM injectable formulations of the drug are sold under the Toradol brand by Syntex with comarketing support from Roche. Other Allergan products pending approval at FDA are Botox (botulinum toxin A) for the treatment of spasmodic torticollis and Complete, a one-bottle contact lens care product. The PLA for Botox was filed in the first quarter of 1991. Botox is in Phase II trials for juvenile cerebral palsy, Shepard said: "What we are seeing in this study is that it [Botox] does relax the muscles, it does allow for normal growth." Allergan must perform trials for "an extended period of time," he noted, to show a lasting impact on the disease. The company plans to file for the indication late in 1994. Botox is also in Phase II for treatment of essential tremor and will enter Phase III trials "either at the end of this year or the beginning of next year," Shepard said. Allergan has several follow-on glaucoma treatment candidates in clinical development. A combination of the company's Betagan (levobunolol) and Propine (dipivefrin) for glaucoma has completed Phase III trials and an NDA will be filed "in the second quarter of this year," Shepard said. Allergan has initiated Phase III trials of the alpha[2] agonist brimonidine for glaucoma and intraocular pressure fluctuations following laser surgery. The firm also has two prostaglandin prodrugs in Phase II, which reduce ocular pressure "by increasing the outflow [of ocular fluid]," Shepard said. Allergan has completed one Phase III trial on its retinoid compound AGN 190168 for the treatment of acne and a second is under way, Shepard said. The first trial "has shown positive results," and Phase III studies of '168 for the treatment of psoriasis will begin "this month," Shepard said. The Phase II trials on two different dosages and two different strengths of the compound showed success rates of up to 63% after eight weeks of treatment, the Allergan exec reported. Eight weeks following treatment "there is virtually no reoccurrence of the disease." The pivotal trials for psoriasis will include longer treatment and follow-up periods.