Ophthotech Corporation (Nasdaq:OPHT) today announced that the Phase 2b study results of Fovista® (pegpleranib), the Company's anti-PDGF agent administered in combination with Lucentis® (ranibizumab) anti-VEGF therapy for the treatment of wet age-related macular degeneration (AMD), have been published online in Ophthalmology®, the journal of the American Academy of Ophthalmology.
The article in Ophthalmology from this prospective, randomized, controlled Phase 2b clinical trial of 449 patients with wet AMD, indicates that Ophthotech’s Fovista® (1.5 mg), administered in combination with Lucentis®, met the pre-specified primary efficacy endpoint of mean change in visual acuity. Patients receiving the combination of Fovista® (1.5 mg) and Lucentis® (0.5 mg) gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis® monotherapy (p=0.019). This represents a 62% additional benefit from baseline. No significant safety issues were observed for either treatment group in the trial.
The published article, “Dual Antagonism of PDGF and VEGF in Neovascular Age-related Macular Degeneration,” can be accessed under "Articles in Press" at: http://www.aaojournal.org/inpress.
“We are honored to have the findings of the Phase 2b Fovista® combination therapy study in wet AMD patients published in Ophthalmology, the journal of the American Academy of Ophthalmology, a highly-respected peer-review publication,” said Samir Patel, M.D., President and Vice-Chairman of the Board of Ophthotech. “The strength of results of this large trial represent the basis for our Fovista® in combination with anti-VEGF therapy Phase 3 registration program for the treatment of wet AMD.”
"We would like to thank all the participating physicians, patients and their staff for their splendid effort in this well conducted trial. We look forward to topline data from the two Phase 3 clinical trials of Fovista® in combination with Lucentis® in the fourth quarter of this year,” said David R. Guyer, M.D., Chief Executive Officer and Chairman of the Board of Ophthotech.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat back of the eye diseases, with a focus on developing innovative therapies for age-related macular degeneration (AMD). Ophthotech's most advanced product candidate, Fovista® anti-PDGF therapy, is in Phase 3 clinical trials for use in combination with anti-VEGF therapy that represents the current standard of care for the treatment of wet AMD. Ophthotech's second product candidate, Zimura®, an inhibitor of complement factor C5, is being developed for the treatment of geographic atrophy, a form of dry AMD, and in combination with anti-VEGF therapy in wet AMD patients. For more information, please visit www.ophthotech.com.
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 Ophthotech, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, Ophthotech’s forward looking statements include statements about the timing and progress of the Fovista ® Phase 3 clinical program. Such forward-looking statements involve substantial risks and uncertainties that could cause Ophthotech’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory approvals or other actions and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that Ophthotech files with the Securities and Exchange Commission. Any forward-looking statements represent Ophthotech’s views only as of the date of this press release. Ophthotech anticipates that subsequent events and developments will cause its views to change. While Ophthotech may elect to update these forward-looking statements at some point in the future, Ophthotech specifically disclaims any obligation to do so except as required by law.
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Last updated on: 31/10/2016
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