The HealthCare segment of Bayer (BAYRY) 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 (mCNV).
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. (REGN) 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 net sales.
Bayer recorded Eylea sales of €49 million in the first quarter of 2013. Approval in the mCNV indication will boost the sales of the drug.
Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile, other stocks such as Jazz Pharmaceuticals Public Limited Company (JAZZ) and Santarus, Inc. (SNTS) currently look more attractive carrying a Zacks Rank #1 (Strong Buy).
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