Perspective

FDA approves Bausch + Lomb glaucoma drop

The FDA has approved the new drug application for the once-daily glaucoma treatment Vyzulta, according to a press release issued jointly by Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals, and Nicox S.A.

Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. It is the first prostaglandin analog to have nitric oxide as one of its metabolites, according to the release.

Following topical administration, the drug metabolizes into two moieties, latanoprost acid and butanediol mononitrate. The latanoprost acid works within the uveoscleral pathway to increase aqueous humor outflow, and the butanediol mononitrate releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm’s canal, according to the release.

“Vyzulta represents the first FDA-approved therapy developed through our proprietary nitric oxide-donating research platform,” Michele Garufi, chairman and CEO of Nicox, said in the release. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”

The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain and instillation site pain, according to the release.

Based on this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15 million payment to Pfizer under a previous license agreement. Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox, according to the release.

The FDA has approved the new drug application for the once-daily glaucoma treatment Vyzulta, according to a press release issued jointly by Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals, and Nicox S.A.

Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. It is the first prostaglandin analog to have nitric oxide as one of its metabolites, according to the release.

Following topical administration, the drug metabolizes into two moieties, latanoprost acid and butanediol mononitrate. The latanoprost acid works within the uveoscleral pathway to increase aqueous humor outflow, and the butanediol mononitrate releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm’s canal, according to the release.

“Vyzulta represents the first FDA-approved therapy developed through our proprietary nitric oxide-donating research platform,” Michele Garufi, chairman and CEO of Nicox, said in the release. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”

The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain and instillation site pain, according to the release.

Based on this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15 million payment to Pfizer under a previous license agreement. Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox, according to the release.

    Perspective
    Carl H. Jacobsen, OD, FAAO

    Carl H. Jacobsen

    I'm thrilled that we have a promising new medication in our armamentarium.

    How is it different from our current medications? Vyzulta (latanoprostene bunod) lowers IOP by promoting uveoscleral and trabecular outflow. Indeed, clinical trials have found it to be modestly more effective than timolol or latanoprost. This may reduce the need for multiple drops, enhancing adherence and decreasing deleterious medication-related effects on the ocular surface. This increased efficacy comes with easy-to-use once-a-day dosing, further enhancing ease of treatment and adherence. Think of Vyzulta as a prostaglandin analogue on steroids. Well, maybe not on steroids, as that might increase IOP.

    I do have reservations, however. I'm concerned that Vyzulta may not live up to the IOP-lowering hype when applied to the general glaucoma population. Additionally, I'm reserving judgment on patient tolerability until I get some firsthand experience. Also, there is always a problem with insurance coverage/cost with new medications. These are minor concerns, however.

    Let's all welcome our new IOP-lowering medication with open arms. We can use all the help we can get.

    • Carl H. Jacobsen, OD, FAAO
    • University of California Berkeley, School of Optometry
      Member, Optometric Glaucoma Society

    Disclosures: Jacobsen is on the Alcon speakers bureau and has been an advisor to Sucampo.