|Ocular's hydrogel platform--Courtesy of Ocular Therapeutix|
Ocular Therapeutix ($OCUL) watched its share price fall nearly 40% on Friday after a pair of clinical trials came up short of success, clouding the future for two pipeline therapies.
The company's most advanced asset, a sustained-release formulation of the anti-inflammatory dexamethasone, came through with mixed results in a Phase III study on allergic conjunctivitis. The hydrogel drug, branded as Dextenza, met its first primary endpoint of relieving ocular itching related to conjunctivitis but missed the mark on its co-primary goal reducing redness, Ocular Therapeutix said. The company was quick to note that redness reduction has never been a requirement for FDA approval in allergic conjunctivitis, and it's not changing its plans for a second Phase III study later this year.
Separately, the company's treatment for glaucoma and ocular hypertension performed worse than the generic eye drop timolol in a Phase IIb study. After 60 days, Ocular Therapeutix's drug, OTX-TP, lowered intraocular pressure by an average of 4.8 mmHg, while timolol brought it down by 6.4 mmHg. At 90 days, the disparity was even greater, the company said. The study was not powered to compare the two treatment groups but rather to inform further development of OTX-TP, Ocular Therapeutix said, and the company is still planning to get its drug into Phase III in the second half of next year after "some minor modification."
The company's explanations for each result failed to resonate with investors, however, as Ocular Therapeutix shares fell to an all-time low on Friday morning.
The latest setbacks come on the heels of a prior Phase III misstep for Dextenza, formerly OTX-DP, in its post-operative pain and inflammation program. In March, Ocular Therapeutix disclosed that the topical treatment met only one of its two primary efficacy endpoints, dimming its prospects for approval. Undaunted, the company submitted Dextenza for FDA review in September, seeking a nod for pain alone, at the same time launching another Phase III trial to prove the drug's worth in inflammation. If all goes according to plan, Ocular Therapeutix expects to win approval in the first indication and later expand Dextenza's label on the strength of the inflammation study.
- read the Dextenza statement
- here's the OTX-TP release