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prised 82 patients. There were no grade IV adverse events reported, and only 16 patients discontinued use due to drug-related events. Dr. Slakter noted that for this study, there were two manufacturers used for the different dosages, and this skewed some of the results ini- tially. The material inside the cap- sule being used in the first iteration of the drug was "about 9 microns in size; the second version was about 30 microns," and this prevented the second formulation from being able to deliver the drug at the same level as the first formulation. Since dis- covering the differences, when ReVision moves ahead with its Phase III study, the first formulation will be followed, Dr. Slakter said. For the Phase IIb study, retinal lesion size was measured by color fundus photography, fundus auto- fluorescence, and fluorescein an- giography. Patients were also evaluated by contrast sensitivity, reading rate, visual acuity, optical coherence tomography, the inci- dence of choroidal neovasculariza- tion, and serum RBP levels. According to ReVision, this is the largest study to date of an oral thera- peutic agent for the treatment of GA. Results from the study found that 43% of the patients in the 300 mg group had a sustained RBP re- duction of at least 60% throughout the trial. Those patients had a me- dian lesion size growth of only 30% from baseline, compared to a me- dian lesion growth of about 50% in the placebo group. Even visual acu- ity loss in patients who experienced reduced lesion size growth was stabi- lized from 12 months to 24 months at six letters lost. On the other hand, the placebo group showed a progres- sive loss throughout the trial, aver- aging an 11-letter loss at 24 months. The incidence of choroidal neo- vascularization was about 13-14% in the fenretinide group (regardless of dosage); it was about 22% in the placebo group. Dry-to-wet AMD conversion ReVision plans on initiating a Phase III study this year and believes it will take about 1,000 subjects to enable the study to be powered correctly. At this point, plans are to have only two arms—a 300 mg fenretinide arm and a placebo arm, the company said. Based on the Phase IIb results, "we have essentially slowed down the deterioration of the cells in the back of the eye," Dr. Slakter said. However, the ability of fenretinide to achieve a level of RBP below the threshold needed to slow the pro- gression may not be sustainable in all people, he warned. An additional benefit of treating a chronic disease like AMD is that if the next phase proves successful, physicians can prescribe the medica- tion and, over the course of time, be able to determine patient compli- ance based on RBP levels. As an aside, Dr. Slakter said fenretinide might have the capabil- ity to reduce the development of choroidal neovascularization by af- fecting the production of vascular endothelial growth factor. "That's a completely separate ef- fect from reducing RBP," he said. "It means the compound might also work as a prevention drug, although we still need to confirm what we found initially." EW Editors' note: Dr. Slakter has financial interests with Digital Angiography Reading Center (New York) and ReVision Therapeutics. Contact information Slakter: 917-951-5659, jslakter@aol.com April 2011 2 9 7 5 B r o t h e r B l v d B a r t l e t t T N 3 8 1 3 3 8 8 8 . 9 0 5 . 7 7 7 0 o d y s s e y m e d . c o m © 2010 Odyssey Medical, Inc. All rights reser ved. †Market Scope Dr y Eye Report (June 2003) ‡McCabe, C. (2009). Punctal occlusion reduces dr y eye symptoms and improves vision. Review of Ophthalmolog y, 16(11), 55-58 *Some conditions apply; call for details. C A L L F O R A F R E E I N T R O D U C T O R Y T R I A L D E S I G N E D L I K E N O O T H E R . 92% # 1 ‡ AMONG ALL COMPETITORS † IN THE DRY EYE MARKET 92 % 0 O 1 0 © 2 u d e r . d e v r e s e s r t h g i l r l . A c n , I l a c i d e y M e s s y d 0 O † t ( r o p e e R y y E r e D p o c t S e k r a M ( 6 1 , y g o l o m l a h t h p f O w o e i v e R . n o i s i s v e v o r p m i d n s a m o t p m y s e y e y r d s e c u ) 3 0 0 e 2 n u J t ( ‡ n o i s u l c c l o a t c n u . P 9) 0 0 2 . ( , C e b a C c M . s l i a t e d r o l f l a ; c y l p p a s n o i t i d n o c e m o S * 8 5 - 5 5 , ) 1 1 ( Patients receiving the 300 mg dose of fenretinide showed significant reduction of retinol binding protein and reduced lesion growth from baseline when compared to placebo Source: ReVision Therapeutics

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