Vyluma Meets with FDA on Atropine Sulfate Ophthalmic Solution 0.01% Under Development to Treat Pediatric Myopia
18 Junio 2024 - 6:30AM
Vyluma, Inc. (“Vyluma”), a clinical stage pharmaceutical company is
focused on the development of ophthalmic treatments for disease
states with limited treatment options. On June 4, 2024, the Company
had a Type A meeting with representatives of the U.S. Food and Drug
Administration’s (FDA’s) Division of Ophthalmology to discuss the
response to FDA’s questions regarding its late-stage product
candidate, Atropine Sulfate Ophthalmic Solution 0.01% under
development to treat pediatric myopia. Vyluma is very encouraged by
the discussion with FDA and will move forward with a submission to
address FDA’s questions in the third quarter of 2024.
“I am very pleased with the discussion that took
place at the meeting with FDA, and we have a pathway forward to
respond to FDA’s Complete Response Letter,” stated George Zorich,
Chairman and CEO of Vyluma. “We believe that Atropine Sulfate
Ophthalmic Solution 0.01% will make a profound difference for
children who are diagnosed with myopia to prevent or reduce further
progression.”
“We are very excited about the results of the CHAMP study,” said
Karla Zadnik, OD, PhD, Glenn A. Fry Professor in Optometry and
Physiological Optics at The Ohio State University and the CHAMP
study principal investigator. Dr. Zadnik stated that, “Myopia leads
to a higher risk for serious eye conditions to develop eventually,
and the higher the level of myopia, the higher the risk for serious
eye diseases. Eye care practitioners’ efforts to treat myopia early
on will be vital to decreasing the risk of long-term negative
outcomes.”
The CHAMP
Study
The CHAMP study was a multinational study that enrolled 576
children with myopia, was conducted partly during COVID, and
demonstrated efficacy for Atropine Sulfate Ophthalmic Solution,
0.01% that is consistent with the benefits reported in the
published literature. The CHAMP study demonstrated a consistent
benefit of Atropine Sulfate Ophthalmic Solution, 0.01% in a
responder analysis, change in spherical equivalent refraction
(SER), change in axial length, and time to change in SER. When the
3 main pre-specified endpoints (responder, mean change in SER, mean
change in AL) were assessed together, it was shown that the
observed favorable benefit in all three endpoints is unlikely due
to chance (p=0.004).
What Is Pediatric Myopia?
Myopia, or nearsightedness, is a common refractive anomaly that
often begins between the ages of six and 14 years and progresses
over several years before stabilizing and lasting through
adulthood. With myopia, the eye’s axial length is longer than
normal (from front to back), which causes light to focus in front
of the retina instead of directly on it.1,2 Those with myopia have
difficulty seeing distant objects, but near objects are clear.
Myopia is a condition that may lead to higher risk of blindness and
serious eye complications later in life.
Myopia is the leading cause of preventable blindness worldwide.3
If current trends continue, it is estimated that by 2050 there will
be approximately 5 billion people with myopia (50% of the world’s
population).4 Higher levels of myopia significantly increase a
child’s risk for serious blinding eye disease in their lifetime,
such as myopic maculopathy, posterior staphyloma, retinal
detachment, cataract, and glaucoma.5
Current Treatment
Options
Interventions to slow the progression of myopia include
spectacles or contact lenses.5 Common treatments for myopia include
various contact lens options, but safety remains a concern because
the risk of sight-threatening microbial keratitis (bacterial
infection of the cornea) and the possibility of regression after
discontinuation of lens wear.4 Spectacles are another treatment
option for children who are unable or prefer not to wear contact
lenses.
Given the impact myopia may have on an individual’s long-term
health and that it is a widespread condition, additional
interventions are needed to help mitigate the prevalence and
severity of this condition.
About Vyluma, Inc.
Vyluma is a development-stage biopharmaceutical company with a
focus on pharmaceutical treatments for refractive errors of the
eye. Vyluma’s pipeline of therapies is led by NVK002, an
investigational, preservative-free, low-dose atropine eye drop to
treat the progression of myopia in children aged 3 years and older.
Vyluma has a robust pipeline of other assets in various stages of
development which address important unmet treatment needs of
patients with refractive errors or eye pain.
Vyluma itself is a subsidiary of Nevakar Inc., a holding company
whose subsidiaries are engaged in developing products for the
ophthalmic and injectable markets. For additional information
please visit www.vyluma.com.
About Nevakar Inc.
Nevakar Inc. is a fully integrated privately held, late-stage
biopharmaceutical company with an extensive portfolio of products
in the ophthalmic and injectable areas. Founded in 2015, and
headquartered in Bridgewater, New Jersey, the Company is focused on
developing and commercializing innovative products to address unmet
medical needs, thereby improving patients’ quality of life and
healthcare outcomes. Nevakar utilizes the US 505(b)(2) regulatory
pathway, along with its proven expertise in the development of
novel and proprietary sterile pharmaceutical products to identify,
develop, and obtain regulatory approval for its products.
Additional information is available at www.nevakar.com.
References
- American Optometric Association. Myopia (Nearsightedness).
Accessed 6/4/2021.
- American Academy of Ophthalmology. Myopia Control in Children.
Accessed 6/4/2021.
- Wu W, Xie Y, Liu X, et al. Analysis of Scientific Collaboration
Networks among Authors, Institutions, and Countries Studying
Adolescent Myopia Prevention and Control: A Review Article.Iran J
Public Health. 2019;48(4):621-631.
- Lawrenson JG, Dhakal R, Verkicharla PK, Shah R, Huntjens B,
Downie LE, Kernohan A, Li T, Virgili G, Walline JJ. Interventions
for myopia control in children: a living systematic review and
network meta‐ Cochrane Database of Systematic Reviews 2021, Issue
4. Art. No.: CD014758. DOI: 10.1002/14651858.CD014758.
- Noel A. Brennan, Youssef M. Toubouti, Xu Cheng, Mark A.
Bullimore. Efficacy in myopia control, Progress in Retinal and Eye
Research. 2020;100923.
Media Contact: Houman Hemmati,
MD, PhDChief Medical Affairs
Officerhhemmati@vyluma.com