Lpath Completes Enrollment Of Patients In ISONEPTM Phase 1 Clinical Trial

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Aug 2009 - 2:00 PDT

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Lpath, Inc. (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, has completed the enrollment and dosing of 15 wet AMD patients in a multi-center, open label, single-arm Phase 1 study of iSONEP administered as a single intravitreal injection to the study eye.

The drug was well tolerated in all 15 patients, and there were no drug-related serious adverse events reported at any of the five dose levels (0.2 mg/eye to 1.8 mg/eye).

In addition, several patients showed a reduction in retinal thickness and regression of lesion size, the two primary efficacy-related endpoints in a single-dose Phase 1 trial. All of these patients had received prior treatments that included at least two doses of Lucentis® and/or Avastin®, the two leading treatment options for wet AMD patients, but were not responding well to these treatments, implying that their lesions were challenging from a treatment perspective.

The company is expected to release a complete analysis of efficacy when all the data is available later this quarter.

Scott Pancoast, Lpath's president and chief executive officer, stated, "The excellent safety record from our Phase 1 study, combined with the efficacy signal from several of the patients, warrants further investigation of the safety and efficacy of iSONEP in one or more Phase 2 trials."

Source
Lpath

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