Inspire studies glaucoma drug; epinastine formulation is patented

Durham, NC-Inspire Pharmaceuticals Inc. has initiated a phase I clinical trial of INS117548 ophthalmic solution for the treatment of glaucoma. The placebo-controlled, dose-escalating trial is designed to evaluate the safety, tolerability, and IOP-lowering effects of the drop in approximately 60 subjects with early-stage glaucoma or ocular hypertension.

INS117548 is a Rho kinase inhibitor designed to lower IOP by disrupting the actin cytoskeleton of the trabecular meshwork. The company also has a Latrunculin B compound, INS115644, related to this platform that is in phase I clinical testing.

“We are pleased to begin clinical testing of INS117548 since it represents a novel approach to lowering IOP,” said R. Kim Brazzell, PhD, Inspire’s senior vice president of ophthalmic research and development. “This is an important milestone for Inspire, as it strengthens our ophthalmic pipeline in disease states with unmet medical need such as glaucoma, which is the second-leading cause of blindness in the United States.”

In other news, the company announced that the U.S. Patent and Trademark Office has issued a method-of-treatment patent related to epinastine HCl ophthalmic solution 0.05% (Elestat) for allergic conjunctivitis. The patent was issued to Boehringer Ingelheim International GmbH, the developer of the drug, and expires Nov. 29, 2020.

Epinastine HCl ophthalmic solution 0.05% is a topical antihistamine with mast-cell stabilizing and anti-inflammatory activity. Inspire licenses it from Boehringer Ingelheim. Allergan Inc. developed the drug to address ocular itching associated with ocular allergies. After the drug was approved in 2003, Allergan entered into a co-promotion agreement with Inspire through which the latter company gained primary responsibility for selling, promoting, and marketing the drop in the United States.

“As [epinastine HCl ophthalmic solution 0.05%] is an important product for Inspire, we are pleased to have patent coverage . . . that extends beyond the exclusivity period granted under the Hatch-Waxman Act,” said Christy L. Shaffer, PhD, president and chief executive officer of Inspire.