Health and Healthcare
Opthotech Craters on Missed Late-Stage Clinical Trial
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Opthotech Corp. (NASDAQ: OPHT) saw its shares crater on Monday after the company reported late-stage results for its treatment of wet age-related macular degeneration (AMD). The company announced that it did not reach the primary endpoints in its two pivotal Phase 3 clinical trials investigating the superiority of Fovista (pegpleranib) anti-PDGF therapy in combination with Lucentis (ranibizumab) anti-VEGF therapy compared to Lucentis monotherapy.
Essentially, the addition of Fovista to a monthly Lucentis regimen did not result in benefit as measured by the mean change in visual acuity at the 12 month time point.
The combined analysis from the two trials (OPH1002 and OPH1003) showed that patients receiving Fovista combination therapy gained a mean of 10.24 letters of vision on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardized chart at 12 months, compared to a mean gain of 10.01 ETDRS letters for patients receiving Lucentis monotherapy.
In the pooled analysis of pre-specified secondary endpoints from both trials, 24.2% of patients receiving Fovista combination therapy gained 20 or more ETDRS letters from baseline at month 12, compared to 22.1% of patients receiving Lucentis monotherapy.
Based on a preliminary analysis of the safety data from these two trials, Fovista combination therapy and Lucentis monotherapy were generally well tolerated after one year of treatment. The ocular adverse events more frequently reported in the Fovista combination therapy group compared to the Lucentis monotherapy group were mainly related to the injection procedure.
David R. Guyer, M.D., CEO of Ophthotech, commented:
We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD. We are thankful to the patients and clinical investigators and their staff for participating in the trials. We will continue to analyze the data from these two studies to better understand the trial results.
Shares of Opthotech were last trading down about 85% at $5.59, with a consensus analyst price target of $90.18 and a 52-week trading range of $5.56 to $80.00.
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