December 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Ophthotech Corporation is cutting between 125 and 135 jobs following the failure of its two Phase III clinical trials combining the company’s Fovista and Genentech’s Lucentis to treat neovascular age-related macular degeneration.
The company announced the layoffs in a Dec. 16 filing with the U.S. Securities and Exchange Commission. In the 8-K filing, Ophthotech said it expects to establish a severance program for the terminated employees. The layoffs are expected to be complete by the second quarter of 2017, the company said. The job cuts will leave the company with 20 to 30 employees, Ophthotech said in its filing.
Shares of Ophthotech were on a bit of a roller coaster ride in aftermarket trading, climbing to $5.03 per share before dropping back to $4.82. This morning the stock is up, trading at $4.92 per share as of 9:30 a.m.
In addition to the layoffs, Ophthotech said it will stop treating patients who are in the second 12 month period of treatment in the two Phase III trials. The company also said it has determined to stop treating patients in its “Fovista Expansion Studies,” trials evaluating the potential additional benefits of Fovista administered in combination with anti-vascular endothelial growth factor, or VEGF, drugs in wet AMD patients.
On Dec. 12, shares of Ophthotech plunged more than 80 percent after trial results showed the combination therapy failed to meet the primary endpoint of superiority for the Fovista and Lucentis combination therapy. The endpoints measured as best corrected visual acuity (BCVA) in terms of additional letter gains over Fovista (ranibizumab) monotherapy. The company said patients treated in one of the combination trials actually fared worse than patients treated with Lucentis alone. The primary efficacy endpoint in both studies was defined as mean change in best corrected visual acuity (BCVA) from baseline at 12 months.
In its report, Ophthotech said after 12 months, patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement. Patients treated with Lucentis (ranibizumab) alone showed a 9.82 letter BCVA improvement, the company said.
While the company has abandoned the Fovista and Lucentis combination, Ophthotech said Fovista was still being tested in combination with other drugs, including Regeneron ’s Eylea and Genentech ’s Avastin. In its 8-K filing, Ophthotech said Phase III trials testing those combinations to treat Wet AMD were ongoing.
In addition to the layoffs, Ophthotech said management was updating the company’s business plan as a result of the failed studies. Regarding the financial impact of the layoffs, Ophthotech said it was unable to “make a good faith estimate” on the expense the company will incur as a result of the job cuts. Ophthotech said it will file an amended 8-K form when it has a grasp on the dollar amount.
