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Re: DewDiligence post# 197830

Wednesday, 12/23/2015 11:19:22 PM

Wednesday, December 23, 2015 11:19:22 PM

Post# of 252179
OPHT > I did not listen to entire CC.. I'm slightly hearing impaired and had a hard time making out what was being said however this Citi research note summarizes the Ph2 data presented...

Getting Even More Bullish – Fovista May Be Next Big Weapon in
wAMD – Raising PT ($128, +$26)

New Ph2 data disclosed at Ophthotech's 12/3 R&D Day suggest Fovista may offer an unprecedented level of efficacy in hard-to-treat wAMD patients. We believe the new findings in challenging wAMD pts (see below/inside) may begin to change the perception of Fovista from a drug with solid potential in certain wAMD pts on anti-VEGFs (we have historically modeled ~25% peak share) to a drug that could eventually see deeper adoption across multiple lines of therapy (i.e. newly diagnosed to anti-VEGF refractory). Thus, we are raising our peak Fovista share in wAMD to ~30%, driving higher peak US Fovista revs of ~$3.1B (vs. ~$2.5B) and moving our PT up to $128 (from $102).

The efficacy picture emerging for the "real-world" pts enrolled in the antifibrosis trial (OPH1005) suggest Fovista may be achieving a level of benefit not typically seen in clinical practice for anti-VEGF monotherapy. OPH1005 enrolled pts where >50% of their CNV lesions contained scar/fibrosis/atrophy, subretinal or subfoveal hemorrhage, and very poor (20/400) baseline vision (i.e. pts typically excluded from wAMD trials given the complexity/heterogeneity of underlying disease). Plus, the trial incorporated a discontinuous treatment schedule
(qtrly injections) after month 6 to simulate "real-world" treatment patterns. While we recognize OPH1005 is 1) uncontrolled, 2) N (16) is modest, and 3) the current data is interim, it is hard to ignore that 1) visual acuity improved 10-14 letters through 13-14 months in a pt population where anti-VEGFs have historically only delivered stable vision or continued vision loss and 2) 0/16 (0%) pts exhibited an increased fibrosis score or developed new fibrosis as determined by independent readers.

KOLs highlighted sig. need for new tools in the wAMD toolkit as anti-VEGF efficacy/outcomes remain sub-optimal especially as disease advances. Plus, retinal specialists have a reputation for deviating from protocol/labels (a familiar theme reiterated at the R&D Day) meaning Fovista's implementation in clinical practice could go beyond initial commercial expectations based on the Ph3s (i.e. newly diagnosed) to potentially include a wide array of anti-VEGF refractory pts.

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