Ophthotech Announces Fovista® Phase 2b Independent Analysis Shows that Fovista® Anti-PDGF Therapy, Combined with Anti-VEGF Therapy, is Associated with a Reduction of Sub-retinal Fibrosis in Wet AMD Patients
- Presentation Will Occur at the 2014
This analysis will be presented on
-
Abstract PA092: "Dual Antagonism of Platelet Derived Growth Factor
(Fovista® 1.5 mg) and Vascular Endothelial Growth Factor
(Lucentis® 0.5 mg) Results in Reduced Sub-retinal Fibrosis
and Neovascular Growth," Authors: Dr.
U. Chakravarthy and Dr. G.J . Jaffe.
The abstract summarizing the analysis is published on the AAO website: https://secure.aao.org/apps/.
Highlights of the Abstract
The purpose of the retrospective analysis was to assess the evolution and severity of sub-retinal fibrosis in eyes with visual loss (n=70) treated with either the combination Fovista® (1.5 mg) and Lucentis® (0.5mg) or monotherapy Lucentis® (0.5mg). Certified and independent readers masked to drug and treatment regimen assessed the evolution and/or progression of fibrosis. Retinal images were graded on a 0 to 4 categorical scale of increasing severity of sub-retinal fibrosis.
The mean change in severity of sub-retinal fibrosis from baseline to the conclusion of the study at 24 weeks was 0.97 vs. 2.0 (P = 0.003), favoring the Fovista® (1.5mg) combination therapy group. At 24 weeks, approximately twice the number of patients on standard of care anti-VEGF monotherapy (54%) were noted to have progression of sub-retinal fibrosis compared to the Fovista® (1.5mg) combination therapy group (27%). In eyes without any sub-retinal fibrosis at baseline, sub-retinal fibrosis developed in 10% of patients receiving Fovista® (1.5mg) combination therapy group compared to 51% in the monotherapy Lucentis® group.
"We are very pleased that the
About Sub-retinal Fibrosis
Sub-retinal fibrosis is a pathological process in the evolution of wet AMD. The formation of fibrosis disrupts the retina and its architecture, which leads to irreversible visual loss. A large (1059 patients) National Eye Institute funded CATT Research Group Study showed that evolution of sub-retinal fibrosis was common in patients with wet AMD treated with monotherapy anti-VEGF therapy. Approximately 32% of patients at one year and 45% of patients at two years developed sub-retinal fibrosis in this CATT trial1.
About the Fovista® Phase 3 Program
Ophthotech's Fovista® Phase 3 program consists of three clinical trials to evaluate the safety and efficacy of Fovista® (anti-PDGF) therapy in combination with anti-VEGF drugs for the treatment of wet age-related macular degeneration (AMD). The Company expects to enroll approximately 1,866 patients in more than 225 centers worldwide. Initial topline data from the Fovista® Phase 3 clinical program are expected to be available in 2016.
About Wet AMD
Age-related macular degeneration is a disease characterized by progressive degenerative abnormalities in the macula of the eye, a small area in the central portion of the retina. Age-related macular degeneration (AMD) is classified into one of two general subgroups: the "dry" (non-neovascular) and the "wet" (exudative or neovascular) form of the disease. The "dry" form of AMD is characterized by a slow degeneration of the macula resulting in atrophy of the central retina, with gradual vision loss over a period of years. The "wet" form of AMD typically causes sudden, often substantial, loss of central vision and is responsible for most cases of severe loss of visual acuity in this disease. AMD is characteristically a disease of individuals aged 50 years or older, and is the leading cause of blindness in developed countries around the world in this age group.
About
Forward-looking Statements
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for
1 Daniel, E; Toth, CA; Grunwald, JE; Jaffe, GJ; Martin, DF;
Fine, SL; Huang, J; Ying, G-S;
OPHT-G
Investors
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
jarrod.aldom@smithsolve.com
Source:
News Provided by Acquire Media