Japes, there have two going, one for Macular Degeneration adn on...

Japes, there have two going, one for Macular Degeneration adn on for Diabetic Macular Edema.

Here a brief summary from Silence Therapeutics website:

PF-'655 in Age-related macular degeneration (AMD)

Market opportunity
Age-related macular degeneration (AMD) is the leading cause of in the elderly. AMD affects 1.7% of people in the US with 200,000 new cases diagnosed there each year. The market for AMD treatments is predicted to reach $2.9bn by 2016 (Source: Credit Suisse).

Current clinical studies
Quark and Pfizer recently completed a phase II trial in 152 with AMD. The trial compared intravitreal injection of Lucentis (Roche/Novartis), the current standard of care, alone, in combination with PF-'655, and sequentially with PF-'655 intravitreal injections. The results of this study have not been announced yet.

Earlier studies:
Quark completed a dose-escalation trial (phase I) with PF-'655 in 2010 (in doses up to 3mg). This study assessed the safety and tolerability of PF-‘655 for the patients enrolled over a 24-Month Period. No drug-related adverse events were observed. Anatomical changes in the retina and choroid were described 14 days after injection of PF-'655. Changes in the visual acuity ETDRS chart were determined 14 days after a single intravitreal injection of the siRNA. More than three quarter of the patients showed improved or stable vision 14 days after a single injection of the siRNA. Moreover, some of the patients (18 of the 27 patients enrolled) showed an improvement on a visual acuity test (mean improvement of 4 letters) after a single injection of the siRNA. While the study was designed to test for safety, and not to assess PF-‘655’s efficacy, these changes were presented as clinically meaningful.
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Products Partners Target
Tissue/Organ Delivery
Method Market
Size ($) Discovery Pre-
clinical Phase I Phase II Delivery Method / Stage
PF-04523655
Diabetic Macular Edema Local Delivery to the Eye Naked siRNA 1.00bn -
potential Naked siRNA / Phase II
PF-'655 in Diabetic Macular Oedema (DME)
Market opportunity
Diabetic macular Oedema is the major cause of blindness in diabetic patients and is a common complication of diabetic retinopathy. DME affects up to 10% of all patients with diabetes with almost one million people affected globally. In the US alone, 75,000 new cases of DME are diagnosed annually. The market for DME treatments is expected to reach $2.6bn by 2016 (Source: Credit Suisse)

Current clinical studies
Quark has initiated a multicentre double blind Phase IIb trial in 264 patient comparing both single and monthly intravitreal injections of PF-'655 to monthly intravitreal injections of Lucentis (Roche/Novartis), the current standard of care in DME. The trial will also compare PF-‘655 in combination with Lucentis to Lucentis alone.


Earlier studies:
In March 2011, Quark announced results of a randomised controlled Phase II clinical trial designed to evaluated the safety and efficacy of PF-'655 in184 patient with DME. Following 12 months of treatment with PF-'655, a dose dependent improvement in visual acuity was observed with the best results achieved at the 3mg dose level. At this dose, the mean improvement from baseline on a visual acuity test was 5.8 letters for all patients enrolled in this dose group while in patients treated with laser photocoagulation control visual acuity improved by only 2.4 letters on average (p=0.08). Furthermore, in a separate secondary analysis of the 111 patients who completed the 12 month follow up visit, the mean improvement from baseline on a visual acuity test in the 3mg group was 9.1 letters while in patients treated with laser photocoagulation control visual acuity improved by only 3.2 letters on average (p<0.01).