Ophthotech Corp (OPHT) Announces Publication of Strong Fovista Phase 2b Data in AMD
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Ophthotech Corporation (Nasdaq: OPHT) 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.
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