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Safety, Efficacy Study Gets Underway for Denufosol Tetrasodium, Treatment for Retinal Detachment

DURHAM, NORTH CAROLINA - April 21, 2004 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today announced the launch of a Phase II clinical trial for INS37217 Ophthalmic (denufosol tetrasodium) for the treatment of rhegmatogenous retinal detachment (RRD). Retinal detachment is a potentially blinding condition that occurs when the retina, a layer of sensory tissue that captures and processes visual information, is separated from the underlying retinal pigment epithelium (RPE). Current first-line therapy for RRD is surgical intervention. Inspire is investigating INS37217 Ophthalmic as the first pharmaceutical treatment for this debilitating condition.

The double-masked, randomized, placebo-controlled, parallel-dose study is designed to compare the safety and efficacy of INS37217 Ophthalmic to placebo as a first-line therapy in patients with RRD. The study will enroll approximately 160 patients in 25 centers across the United States. INS37217 Ophthalmic is formulated as a sterile solution and delivered by intravitreal injection. The study design provides for a single injection of INS37217 Ophthalmic or placebo, and allows for up to two additional consecutive daily injections in patients who show signs of improvement following the previous injection. This study design was discussed in detail at a meeting with the Food and Drug Administration in January 2004.

Commenting on Inspire's progress, Henry Hudson, M.D., F.A.C.S., Principal Investigator, Retina Centers, P.C., Tucson, stated, "This investigational drug is exciting because it has the potential to significantly improve the management of rhegmatogenous retinal detachments. If effective, INS37217 Ophthalmic would provide vitreo-retinal surgeons with a novel pharmaceutical approach to treating patients with this sight-threatening condition."

Christy L. Shaffer, Ph.D., Inspire's CEO, added, "The activation of P2Y2 receptors in the back of the eye to remove pathological fluid is an approach that could potentially provide benefit for patients with RRD, as well as for patients with other sight-threatening diseases that involve fluid accumulation in or around the retina. Plans are ongoing to develop INS37217 Ophthalmic for chronic conditions such as macular edema associated with diabetes, uveitis, and age-related macular degeneration (AMD). Inspire is committed to developing novel ophthalmic products and to exploring the multiple opportunities for P2 receptor-based therapies."

About Rhegmatogenous Retinal Detachment (RRD)
RRD is the most common form of retinal detachment. It is an acute and often chronic sight-threatening condition. RRD occurs as a result of retinal breaks or tears that allow fluid from the vitreous to accumulate in the sub-retinal space - the space between the retina and the RPE. INS37217 Ophthalmic is a P2Y2 receptor agonist that has been shown to stimulate the removal of accumulated fluid in the sub-retinal space. Removal of the sub-retinal fluid is critical for retinal reattachment. Current first-line therapies for RRD include three commonly employed surgical techniques: scleral buckle, vitrectomy and pneumatic retinopexy. These surgeries often involve significant pain and discomfort, protracted recovery periods and frequent post-surgical complications. INS37217 Ophthalmic, if effective, could reduce the need for these surgical interventions.

Source: Inspire Pharmaceuticals

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