Health and Healthcare

pSivida Soars on Positive Late Stage Results

Chris Lange

Published: December 22, 2015 11:45 am

Last Updated: January 13, 2020 3:48 pm

pSivida Corp. (NASDAQ: PSDV) was leading the bulls in Tuesday’s session on positive results from a late stage trial. The company announced positive top-line results from its first Phase 3 clinical trial evaluating the safety and efficacy of Medidur for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis).

The primary endpoint of pSivida’s Phase 3 trial was prevention of recurrence of disease at six months.

The safety results from the trial were positive. Only 10.9% more Medidur-treated eyes than control eyes experienced an increase in intraocular pressure above 21 mmHg through six months, which was reduced to 6.1% through the most recent follow-up visits (some as long as 24 months). In the Medidur trial, 87 eyes were treated with Medidur, and 42 eyes were randomized to control and received a sham injection.

Dr. Glenn Jaffe, Duke University Robert Machemer Professor of Ophthalmology and chief of the Division of Retinal Ophthalmology, as well as principal investigator for this trial, commented:

The results of this Phase 3 trial are extraordinary. With a single injection, Medidur showed the ability to control the recurrence of posterior uveitis, improve visual acuity and prevent vision loss. The high level of statistical significance achieved in this trial is dramatic and, along with the compelling benefit-risk ratio, suggests an important treatment option for patients who are typically treated with repeated systemic steroids, immuno-suppressants or biologics, often facing recurring attacks of the disease as well as systemic side effects.

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Dr. Charles Foster, Clinical Professor of Ophthalmology at Harvard Medical School and founder and president of the Massachusetts Eye Research and Surgery Institution, added:

The results from this Phase 3 trial indicate that Medidur has the opportunity to be an effective, safe and convenient treatment for this blinding eye disease, avoiding the potentially serious side-effects and administration compliance challenges of the cycles of systemic steroids, immuno-suppressants and biologics now used to treat the disease. The ability to administer a three-year course of Medidur therapy for posterior uveitis in a single, in-office injection could allow many patients to significantly improve treatment outcomes and vision, reduce side effects and drastically simplify patient compliance as compared to current treatment alternatives.

Shares of pSivida were trading up over 29% at $4.80 late Tuesday morning, with a consensus analyst price target of $7.63 and a 52-week trading range of $3.23 to $5.80.