Eton, Bausch Win FDA Approval For Preservative-Free Allergy Eyedrops

After an initial rejection in 2019 and a string of delays following a refiling of the regulatory application, Eton Pharmaceuticals Inc's ETON out-licensed allergic conjunctivitis ophthalmic solution is finally ready to see the light of the day.

FDA Hurdle Cleared: The FDA gave its nod to an EM-100 ophthalmic solution, 0.035%, antihistamine drop, to be used as the first over-the-counter, preservative-free formulation eye drop to temporarily relieve itchy eyes dye to pollen, ragweed, grass, animal hair and dander in adults and children 3 and older, Eton and Bausch Health Companies Inc BHC said.

Eton out-licensed EM-100 to Bausch Health in February 2019.

Itchy eyes are one of the symptoms that affect approximately 80% of people with allergies, the companies said.

The preservatives commonly used in eye drops can cause allergic reactions in some people that can lead to redness, irritation, itching or tearing. 

What's Next: Bausch expects to make EM-100, or Alaway Preservative Free, available in the spring of 2021 at major retailers in time for the start of allergy season.

"We are pleased the FDA has approved Alaway Preservative Free, and we look forward to collaborating with Bausch + Lomb to bring this unique eye drop to patients suffering from itchy eyes associated with eye allergies," Eton CEO Sean Brynjelsen said in a statement. 

BHC, ETON Price Action: Eton shares were rising 2.19% to $8.36 at last check Friday, while Bausch shares were down 0.72% at $15.12. 

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