The HealthCare segment of
) recently announced positive top-line results from the phase III
MYRROR study on VEGF Trap-Eye (aflibercept ophthalmic solution)
in patients suffering from myopic choroidal neovascularization
Bayer now intends to submit its first regulatory approval
application in Asia for VEGF Trap-Eye in this indication in the
latter half of the year. Bayer also plans to present data from
the MYRROR study at an upcoming medical conference.
Results from the study showed that patients who received 2
milligrams (mg) dose of VEGF Trap-Eye experienced a mean
improvement in best-corrected visual acuity (BCVA) from baseline
of 12.1 letters compared to a loss of 2 letters in patients who
were administered sham injections. The candidate was also well
tolerated during the study.
Conjunctival hemorrhage, dry eye, eye pain, headache and
nasopharyngitis were some of the most common adverse events
observed during the study.
We note that VEGF Trap-Eye is already approved in the US,
under the trade name Eylea, for the treatment of neovascular
(wet) age-related macular degeneration (AMD). The drug was later
approved for the treatment of macular edema following central
retinal vein occlusion (CRVO) as well. The drug is also approved
for the wet AMD indication in Japan, Australia, Europe and
several other countries.
Bayer has a collaboration agreement with
Regeneron Pharmaceuticals Inc.
) for the global development of Eylea. Per the terms of the
agreement, Regeneron owns the entire US rights pertaining to the
eye drug. Bayer is however responsible for marketing Eylea in
ex-US markets on approval. The profit earned from the sales of
Eylea in those markets will be shared equally by the companies.
However, in Japan, Regeneron will receive royalties on Eylea's
Bayer recorded Eylea sales of €49 million in the first quarter
of 2013. Approval in the mCNV indication will boost the sales of
Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile,
other stocks such as
Jazz Pharmaceuticals Public Limited Company
) currently look more attractive carrying a Zacks Rank #1 (Strong
BAYER A G -ADR (BAYRY): Free Stock Analysis
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