pSivida (PSDV) Misses Q2 EPS by 3c

pSivida (NASDAQ: PSDV) reported Q2 EPS of ($0.18), $0.03 worse than the analyst estimate of ($0.15). Revenue for the quarter came in at $526 thousand versus the consensus estimate of $980 thousand.

Highlighting the quarter were the positive topline results reported from the first of two Phase 3 trials of the Company’s lead product candidate Medidur™ for posterior uveitis. The 129 patient, multi-center, randomized and double-masked trial met its primary efficacy endpoint of prevention of recurrence of disease at six months with high statistical significance (p less than 0.00000001; intent to treat analysis). Safety results were also positive. Only 10.9% more Medidur-treated eyes than control eyes experienced an increase in intraocular pressure (IOP) 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). Exploratory analyses of Medidur-treated eyes relative to control through six months also showed statistical significance for improvement in visual acuity (gain of 15 or more letters on the ETDRS Eye Chart), prevention of vision loss (loss of 15 or more letters) and reduction in systemic therapy.

As a result of the high statistical significance achieved in the trial results, pSivida intends to file for European Union (EU) marketing approval based on data from the single Phase 3 trial. The U.K. Medicines and Healthcare Products Regulatory Agency earlier advised pSivida that, consistent with published EU regulatory guidance, an application for a product treating a condition like posterior uveitis could be based on statistically compelling and clinically relevant results from just one pivotal trial.

“We believe that the level of statistical significance achieved in our first Phase 3 trial results should permit us to file our EU marketing approval application based on those results, accelerating the timing of planned submission toward the end of this year, rather than in 2017 as was originally planned,” said Paul Ashton, Ph.D., president and CEO of pSivida.

“We have also requested a meeting with the U.S. Food and Drug Administration (FDA) to confirm, in light of our first Phase 3 trial results, that data from two trials will continue to be required for our U.S. New Drug Application (NDA), currently planned for the first half of calendar 2017,” continued Dr. Ashton.

Following announcement of the trial results, pSivida completed a $17.8 million underwritten public offering of common stock. “With the addition of approximately $16.4 million of net proceeds from the offering, we believe we are in a position to continue our planned operations past the planned Medidur NDA filing and into the fourth quarter of calendar 2017,” said Dr. Ashton.

pSivida and Hospital for Special Surgery, the leading specialty hospital for orthopedics and rheumatology, have collaborated to develop a Durasert™ implant to provide sustained treatment of pain associated with severe knee osteoarthritis (OA) with a goal of delaying or eliminating the need for knee replacement surgery. An investigational new drug application (IND) for an investigator-sponsored, six-month open label study of the implant was submitted to the FDA in the fourth quarter of calendar 2015. The FDA advised the principal investigator that stability data for the implants to be used in the study will be required prior to initiating the study. “The data requested by the FDA should not be difficult to develop, but will take time. We understand that HSS expects the study to commence this summer. Severe knee OA, the first use of our Durasert technology outside ophthalmology, could be a significant opportunity, with over 700,000 knee replacement surgeries from the disease in the US alone each year,” said Dr. Ashton.

pSivida continued to advance its pre-clinical programs evaluating the use of Durasert to deliver off-patent or soon-to-be off-patent anti-cancer drugs that inhibit VEGF and PDGF to treat wet and dry age-related macular degeneration and Tethadur™ to deliver antibodies.

For earnings history and earnings-related data on pSivida (PSDV) click here.

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