Inspire Pharmaceuticals (Nasdaq: ISPH) reported encouraging results of a Phase I/II clinical trial for its drug INS37217 Ophthalmic which is for use in patients with rhegmatogenous retinal detachment.

Inspire says INS37217 Ophthalmic, delivered as a single-dose injection into the eye, was well tolerated at all doses tested, with no drug-related serious adverse events reported.

Retinal detachment is a potentially blinding condition that occurs when the retina is separated from the underlying retinal pigment epithelium (RPE). Rhegmatogenous retinal detachment is the most common form of retinal detachment, and occurs as a result of retinal breaks that allow fluid to accumulate in the space between the retina and the RPE.

INS37217 Ophthalmic has been shown to stimulate the removal of accumulated fluid in the sub-retinal space, Inspire says. Removal of the sub-retinal fluid is critical for retinal re-attachment.

Although assessment of safety and tolerability was the primary objective of the study, effect on extent of retinal detachment was also evaluated. This evaluation included the use of two independent, quantitative measures to determine the change in the extent, or surface area, of the retinal detachment. Patients treated with INS37217 Ophthalmic showed improvement in the extent of retinal re-attachment as determined by both objective measures. Patients treated with placebo showed no improvement as determined by the same two measures.

The study was a randomized, placebo-controlled, double-masked dose-escalation comparison of INS37217 Ophthalmic solution to placebo. INS37217 Ophthalmic and placebo were both delivered by injection into the eye (intravitreal). There were 14 patients enrolled into the study at two investigational sites.

“This study was conducted in a small number of patients to determine the safety and tolerability of INS37217 delivered by intravitreal injection,” Christy Shaffer, chief executive officer of Inspire, said in a statement. “We have established that intravitreal delivery of INS37217 is well tolerated, and have in addition seen promising results in the extent of retinal re-attachment in patients treated with INS37217 Ophthalmic. Our next step in the program is the planning of a definitive Phase II trial. If successful, this program would allow us to further expand our presence in ophthalmology.”

Inspire Pharmaceuticals: www.inspirepharm.com