Fallimenti a catena
Eleven Bio Releases Latest in String of Disappointing Results
When Eleven Biotherapeutics’ stock plunged almost 70% on Monday after the company announced disappointing results from its Phase 3 study of EBI-005 for treatment of dry eye, it was the fourth time this year an ophthalmic biotech stock did a one-day tank after the company announced disappointing clinical trail results.
Before the market opened Monday, Eleven Biotherapeutics President and CEO Abbie Celniker, PhD, said in a conference call that the EBI-005 did not show any difference in ocular pain and discomfort when compared to the vehicle control group. “Based on these top-line results, the company does not see an immediate path forward for EBI-005 in dry eye disease, and we will not be initiating the second Phase 3 study of EBI-005 in dry eye disease that we had planned to start in the second half of this year,” Dr. Celniker said.
Now, Eleven Biotherapeutics (NASDAQ:EBIO) will focus development of EBI-005 on treatment of allergic conjunctivitis based on its Phase 2 data. The stock closed at $3.69 on Monday, down from $11.97 at its close on Friday, May 15. The stock did rebound some from its $2.90 opening on Monday.
Among other seismic shifts in stock prices this year are:
Aerie Pharmaceuticals ($11.22 at Monday close; NASDAQ:AERI) announced after the market closed on April 23, that the early Phase 3 results of its Rhopressa one-day eyedrop for lowering intraocular pressure failed to meet its primary endpoint of showing comparable efficacy to twice-daily timolol. Aerie stock dropped 60% from $35.39 to $12.87 on the day after the announcement. On Monday, a Philadelphia area law firm announced it had filed a class action suit alleging that Aerie executives had made misleading statements about the company’s prospects.
Ocular Therapeutix ($26.43 at Monday close; NASDAQ:OCUL) announced on April 6, that topline data from the second of two Phase 3 clinical trials of OTX-DP sustained-release dexamethasone (0.4 mg) punctum plug for ocular inflammation and pain following cataract surgery met only one of two primary efficacy endpoints—absence of pain vs. placebo; whereas results of efficacy for treatment of inflammation were not statistically significant from placebo. Ocular Therapeutix’s stock fell 19%, from $38.30 to $31.05, the day after the announcement, but had fallen a third through the week of the announcement. Last week Ocular Therapeutix said it plans to submit a New Drug Application (NDA) for OTX-DP for the treatment of post-surgical ocular pain, based on a meeting with the Food and Drug Administration (FDA) in April 2015.
On March 27, shares of Ohr Pharmaceutical ($2.77 at Monday close; NASDAQ: OHRP) plunged 69% when the company announced the topline results from the exploratory Phase II IMPACT study evaluating OHR-102 (0.2% squalamine lactate ophthalmic solution) combination therapy for the treatment of the wet form of age-related macular degeneration (wet-AMD). The results showed that while OHR-102 combination therapy with Lucentis showed greater vision gains than Lucentis monotherapy, the primary study endpoints—mean number of injections between the OHR-102-Lucentis combination therapy group and Lucentis monotherapy groups—were not meaningfully different.
Overall, stock prices of companies that went public in recent years held steady, suggesting that investors don’t have broader concerns about the sector. After all, the ophthalmology sector is generating positive news as well.
MIGs leader Glaukos Corp. last week filed to go public based upon its strong commercial success of its iStent Trabecular Micro-Bypass Stent.
Meanwhile, privately held Transcend Medical, Inc. announced its plans to file a premarket approval (PMA) application for its CyPass Micro-Stent following the positive outcome of its COMPASS pivotal trial evaluating the device.
While the sector celebrates some successes, public investors clearly are ready to punish any company bringing forth disappointing clinical trial results.
