`
`Opthotech's Fovista crashes out in wet AMD | BioPharma Dive
`
`BRIEF
`
`Published Aug. 14, 2017
`
`By
`Suzanne Elvidge
`
` Contributor
`
`Eye disease specialist Opthotech Corp. reported Monday a third
`and final Phase 3 trial of its experimental therapy Fovista failed
`to meet its primary goal, another setback after two previous
`late-stage studies failed late last year.
`
`The OPH1004 study tested Fovista in combination with
`Regeneron Pharmaceuticals, Inc.'s Eylea or Roche AG's
`Avastin in patients with wet acute macular degeneration
`(AMD). Adding Fovista to the two drugs, however, did not
`improve visual acuity at 12 months compared to either Eylea or
`Avastin monotherapy.
`
`As a result, Opthotech said it will stop treatment of patients who
`are in the second year of the study, but the company confirmed
`it would continue to develop candidates to treat orphan retinal
`diseases.
`
`Opthotech's fortunes appeared much brighter back in 2014, when
`Novartis AG inked a deal for rights to Fovista (pegpleranib) in wet
`AMD outside the U.S.
`
`https://www.biopharmadive.com/news/opthotech-fovista-phase-3-failure-setback-novartis/449248/
`
`1/3
`
`Regeneron Exhibit 2026
`Page 01 of 03
`
`Opthotech's Fovista crashes
`out in wet AMD
`Dive Brief:
`Dive Insight:
`
`
`8/2/2021
`
`Opthotech's Fovista crashes out in wet AMD | BioPharma Dive
`
`The Swiss pharma paid $200 million upfront, with another $130
`in a near-term enrollment milestone, to access the drug. Other
`milestone payments pushed overall deal value to above $1 billion.
`
`Last year, however, the combo of Fovista and Novartis' Lucentis
`(ranbizumab) failed in two Phase 3 trials, with no significant
`improvements in visual acuity in wet age-related macular
`degeneration (AMD) compared with patients given Lucentis alone.
`
`At the time, Jefferies analysts suggested the results could be a nail
`in the coffin for anti-PDGF therapies like Fovista in wet
`AMD. Ophthotech's shares dropped nearly 85% in value, and the
`company announced that it would halt the two studies and cut
`between 125 and 135 staff.
`
`Last month, Novartis and Ophthotech suspended much of their
`deal, effectively putting things on hold until it was clear whether
`the drug could prove its effectiveness. Positive results from the
`OPH1004 might have changed the picture somewhat but the
`negative results further confirm Fovista's lack of efficacy when
`paired with anti-VEGF therapies.
`
`According to Ophtotech, treatment with the combo led to an
`average improvement of 0.38 letters of vision over either
`monotherapy as measured by the ETDRS standardized chart after
`one year. The results were not statistically significant.
`
`While this presumably means an end to Fovista in wet AMD,
`Ophthotech remained upbeat on its clinical pipeline.
`
`"This outcome does not affect our strategy as the Company moves
`forward with multiple ongoing or planned clinical programs in
`orphan retinal diseases coupled with multiple ongoing or planned
`clinical trials in back of the eye indications," said company CEO
`Glenn Sblendorio in a statement.
`
`https://www.biopharmadive.com/news/opthotech-fovista-phase-3-failure-setback-novartis/449248/
`
`2/3
`
`Regeneron Exhibit 2026
`Page 02 of 03
`
`
`
`8/2/2021
`
`Opthotech's Fovista crashes out in wet AMD | BioPharma Dive
`
`Shares in Opthotech fell in opening trading Monday before gaining
`about 10 cents to rise to $2.65 per share.
`
` OPHTHOTECH
`Press release
`
`https://www.biopharmadive.com/news/opthotech-fovista-phase-3-failure-setback-novartis/449248/
`
`3/3
`
`Regeneron Exhibit 2026
`Page 03 of 03
`
`Recommended Reading:
`
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