The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age.
Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."
Myopia is a common vision impairment in which objects up close appear clearly but those in the distance are blurred. It is caused by elongation of the eye, which causes light rays to focus in front of, rather than on, the retina. The condition usually begins in childhood and worsens with age, with people having severe myopia being at higher risk of other eye problems such as cataracts or a detached retina. Worldwide, myopia affects about 1.5 billion people, including between 30% and 40% of Americans.
Early 2020 launch
Misight works in part like a traditional prescription lens, correcting the refractive error caused by myopia to improve distance vision. But its therapeutic benefit comes from concentric peripheral rings in the lens, which focus part of the light in front of the retina, which reduces the stimulation that causes myopia to progress.
Pleasanton, Calif.-based Coopervision, a division of Coopercompanies Inc., said it will launch Misight in the U.S. as part of a myopia management program beginning next March.
"We can't overstate the importance and potential impact of this landmark decision on children's vision, especially considering the rise in myopia's severity and prevalence in the U.S. and worldwide," said Daniel McBride, president of Coopervision. "Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children."
The FDA based its approval on a prospective, randomized, controlled trial of 135 children ages eight to 12 when the study began who used either Misight on a conventional soft contact lens. The results, published in the August 2019 issue of Optometry and Vision Sciences, showed that use of Misight 1 day slowed myopia progression by 59%, as measured by mean cycloplegic spherical equivalent, and by 52%, as measured by mean axial lengthening of the eye.
A separate retrospective analysis of medical records of 782 children in the same age range who wore contact lenses found that they were no more likely to get corneal infections than contact lens-wearing adult. As part of the approval, the FDA is requiring Coopervision to conduct a postmarket study to collect additional evidence of Misight's safety and efficacy.
"The time and effort we put into receiving FDA approval was well spent," said Jerry Warner, Coopervision's executive vice president of Americas and global commercial function. "We're bringing a game-changing myopia management approach to U.S. eye care professionals that will benefit countless kids throughout the country."
Coopercompanies has been banking on future growth of its Misight myopia and Myday multifocal lenses to boost soft sales in multifocal contact lenses, which have been hurt by competition. (See BioWorld MedTech, Sept. 3, 2019.) Misight is already approved in Canada, much of Europe and several Asia-Pacific countries. In the third quarter of fiscal year 2019, ended June 30, Misight chalked up $1 million in revenue, more than twice the amount in the same period the prior year.
During a third-quarter earnings call, Albert White, president and CEO of Coopercompanies, said the company had ramped up prelaunch investments in the U.S. in advance of an expected year-end approval, and was putting sales, marketing and educational activities outside the U.S. into high gear as well. "These investments will add several million dollars in additional cost in Q4 that I'm excited to see the results as I remain excited about Misight's potential and the positive halo effect it will have on the rest of our portfolio," White said.
Wells Fargo analyst Larry Biegelsen echoed that optimism, calling the approval of Misight an "important milestone" for Coopercompanies as the sole FDA-approved product for slowing near-sightedness progression and several years ahead of its competitors. "FDA approval of Misight may help accelerate OUS adoption of the product, which has been annualizing sales of ~$4MM, and have a halo effect on the rest of COO's US contact lens portfolio," he wrote in Sunday research note.
According to Biegelsen, the company plans to price Misight as a premium contact lens and market it as a myopia treatment, not just a corrective lens. He believes global sales of Misight could reach $50 million in five years, but said some consultants put the forecast above $100 million by 2025.
"We expect modest initial sales ramp – $5-$10MM – in FY20 as COO will focus on physician and parent education and physician training to start," he wrote. "We estimate that every $20MM of additional Mist revenue would add ~100bps to CVI sales growth."
Coopercompanies' stock (NYSE:COO) stood at $305.69 at the close of the markets on Monday, up 1.23% from Friday's close of $301.98. Biegelsen forecast a $362 price target for the stock, rating it "outperform."