EYET; there are other issues. Alcon expecting to launch RETAANE about mid-2005. It's a depot that only needs to be injected twice a year. Further, Pfizer has little or no presence in the opthalmic market, whereas Alcon is one of the guerillas. My guess is Alcon reps will outsell Pfizer reps. The drug reflux issue, though "controllable" seems to be a little fly in Alcon's ointment.
>>FORT WORTH, Texas – December 16, 2004 – Alcon, Inc. (NYSE:ACL) has submitted the third and final reviewable unit of its New Drug Application (NDA) for RETAANE® 15 mg (anecortave acetate for depot suspension) to the U.S. Food and Drug Administration (FDA). The application is subject to formal acceptance by the FDA, which could take up to 45 days from the date of submission. Alcon also has submitted its European Marketing Authorisation Application (MAA) for RETAANE® suspension. Alcon is seeking approval of the drug as a treatment for patients with subfoveal choroidal neovascularization due to age-related macular degeneration.
In the U.S., RETAANE® depot is being reviewed under the FDA’s new Pilot 1 Continuous Marketing Application (CMA) program for fast track designated products, which allows designated NDAs to be submitted in specified reviewable units as each is completed, with each one assigned its own six-month review target.
The FDA has completed its initial review of the RETAANE® depot Chemistry, Manufacturing and Controls unit, which was filed in 2003, and the Pre-Clinical unit, which was filed in March of 2004. Alcon has responded to all questions posed by the FDA to date. The FDA also has completed its pre-approval inspection of Alcon’s manufacturing facility, with no negative findings (no 483 observations).<<
>>NEW ORLEANS, Oct. 21 /PRNewswire-FirstCall/ -- Alcon, Inc. (NYSE: ACL - News) presented more details about its Phase III clinical study comparing Retaane® 15 mg Depot (anecortave acetate for depot suspension) to Visudyne® photodynamic therapy (PDT) in the treatment of wet age-related macular degeneration (AMD). Alcon presented this data to its Anecortave Acetate Clinical Study Group at the annual conference of the American Academy of Ophthalmology in New Orleans.
The presentation included general information about Retaane® Depot and a detailed summary of the design and results of the study. It also included analyses of the impact on visual acuity of treatment interval and drug reflux. In a press release on October 13, Alcon identified drug reflux and treatment interval as two controllable factors that negatively impacted the overall results of its study. Reflux occurs when a portion of the medication leaks out through the small incision in the conjunctiva during or immediately after application of the drug. The recommended treatment interval for patients in the study was once every six months.
Fifty percent of per protocol patients who did not have drug reflux during their second administration maintained vision compared to 39 percent for those who experienced such reflux (p=.105). As for treatment interval, 50 percent of per protocol patients who received their second dose of Retaane® Depot within 182 days maintained their vision compared to 33 percent for those who received it after 182 days (p=.021).
Alcon's presentation also included a per protocol analysis of the cumulative percentage of patients in the Retaane® Depot arm who maintained vision when treated within a clinically relevant date range, which is defined as six months plus 21 days. The analysis was done on all patients and on patients who did not experience drug reflux on re-administration. The cumulative analysis that was presented began at 175 days and ran for each day up to the maximum interval for any patient in the per protocol data set. A 182 day time point was specifically identified because it reflects a six-month treatment interval for Retaane® Depot.
For all patients treated per protocol in the study, 44 percent maintained vision when receiving their second treatment within 175 days, 50 percent when treated within 182 days and 45 percent when treated within the maximum per protocol timeframe for the second administration. For all patients treated per protocol in the study who experienced no reflux during their second administration, 54 percent maintained vision when receiving their second treatment within 175 days, 57 percent when treated within 182 days and 50 percent when treated within the maximum per protocol timeframe for the second administration. These results are compared to 49 percent of patients who maintained vision when treated with PDT. They indicate that Retaane® Depot is not statistically different from PDT, but because of the reduction in sample size due to reflux and treatment interval, they do not statistically demonstrate non-inferiority. Maintenance of vision is defined as less than a three line loss in logMAR visual acuity at month 12 of the study.
The presentations also provided detailed side effect data that confirmed there were no clinically relevant safety issues associated with Retaane® Depot or the posterior juxtascleral depot procedure during this course of the study.
Alcon reiterated to attendees at the meeting that it would continue to analyze all the data from this study and planned to submit its NDA for Retaane® Depot to the U.S. Food and Drug Administration (FDA) by the end of the year. With this information, and in light of the severity of the disease and the limited therapies available to treat wet AMD, the company is hopeful the FDA will consider the company's entire package of efficacy and safety data in making a risk versus benefit assessment of Retaane® Depot.
Alcon management will host a web cast on Friday, October 22, 2004 at 3:30pm Eastern Time to review the company's businesses and discuss the results of the study in more detail. The call can be accessed at alconinc.com .<<
snip
Lucentis, DNA's entry, is in PIII. The ANCHOR trial completed enrollment last quarter, so it won't be out till 2006, I'd guess.
Cheers, Tuck |
