pSivida: Sustained-Release Therapies

CHICAGO—pSivida has created a business model to solely concentrate on preventing blindness through proprietary sustained-release drug technologies, said newly appointed president and CEO Nancy Lurker. She spoke here during the Ophthalmology Innovation Summit.

The company has already developed three of the four FDA-approved sustained-release products in the retina space, she said, adding that the technology has been licensed to both Bausch + Lomb and Alimera Sciences.

Lurker said pSivida is now concentrating on two “highly attractive programs”: uveitis and wet age-related macular degeneration (AMD), the former with its Medidur technology.

“The prevalence of posterior segment uveitis is 175,000 cases in the US,” she said, giving the Medidur program the potential to exceed $100 million in annual revenue within the first five years of commercialization. In the first of two Phase III studies (n = 129 in the first), Medidur reached the primary endpoint of preventing uveitis recurrence 3.9 times more than sham eyes at 6 months, and 5.1 times more than sham eyes at 12 months (18.4% vs. 78.6% at 6 months and 27.6% vs. 85.7% at 12 months, respectively; p < 0.001). At 6 months, 22.9% of the Medidur eyes gained at least 15 letters (compared with 7.3% of the sham eyes); the results for Medidur held through 12 months, suggesting the treatment quickly returns vision and can maintain stabilization. Additionally, Medidur had a significant systemic sparing medication effect, with only 18.2% of patients still on a systemic medication at six and 12 months, compared with 52.4% of the sham eyes.

A second study enrolling 150 patients is expected to complete enrollment by the end of the year, Lurker said.

pSivida plans to file for marketing authorization in the first quarter of next year and to submit a New Drug Application during the second half of 2017.

Durasert is also being investigated for wet AMD. Tyrosine kinase inhibitors have been shown to inhibit two leading factors involved in wet AMD, and IND-enabling studies with bioerodable Durasert are underway.

Finally, the company is sitting on $29 million in cash and has no debt. By the end of the year, it will have a clear operating plan, and will have established a three-year strategic plan.

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