LumiThera first signed an agreement to acquire Diopsys in November of last year, which is expected to help create a complementary diagnosis and monitoring platform to the company’s eye care treatment platform Valeda light delivery system.
The US Food and Drug Administration (FDA) has not yet approved the Valeda light delivery system, which received CE mark approval.
Diopsys provides technology for visual evoked potential (VEP) and ERG vision testing.
The company’s product portfolio consists of Diopsys NOVA, Diopsys ARGOS, and Diopsys RETINA PLUS ERG and VEP vision testing system product series and the Enfant pediatric VEP vision testing system.
“The theranostic company will provide the tools eye care professionals need to diagnose, treat, and monitor patients, providing a solution for multiple ocular diseases with limited treatment options.”Joe Fontanetta, Diopsys president.
The acquisition of LumiThera comes ahead of the expected release of data from its 13-month US LIGHTSITE III trial in intermediate dry age-related macular degeneration (AMD) patients.
The trial enrolled 100 people who received Valeda treatments every four months.
A 13-month efficacy timepoint for all patients, according to the company, will provide a predetermined early look at the primary vision endpoint.
Based on the results, the company will conduct additional efficacy testing to support FDA approval.
LumiThera president and CEO Clark Tedford said: “The LIGHTSITE III trial mirrors FDA approval trials for wet AMD drugs in endpoints and duration, in measuring the progression of vision loss in intermediate dry AMD patients, and how Valeda treatments can improve vision and impact disease progression.”
In September 2020, LumiThera partnered with Diopsys to conduct a human clinical trial to treat dry AMD patients.
Meanwhile, Johnson & Johnson (J&J) Vision Care has announced that its ACUVUE Theravision with Ketotifen has been approved by the US Food and Drug Administration.
ACUVUE Theravision with Ketotifen contact lenses are daily wear, daily disposable drug-eluting contact lenses that contain 19mcg ketotifen, a popular antihistamine.
According to the company, the new contact lenses with ketotifen are intended for vision correction in patients who do not have red eyes and do not have more than 1.00 D of astigmatism.
Johnson & Johnson Vision Care North American president Thomas Swinnen said: “At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health.
ACUVUE Theravision with Ketotifen, according to J&J, is the world’s first and only drug-eluting daily disposable contact lens that will provide a new experience of wearing a lens with allergic eye itch.
The FDA approval follows the publication of Phase 3 clinical studies in the journal Cornea, as well as regulatory approval from the Japanese Ministry of Health, Labor, and Welfare and Health Canada.
The phase 3 study found that itchiness was reduced within 3 minutes of lens insertion and lasted for up to 12 hours.
According to the company, the lens can be worn for more than 12 hours to correct vision.
LumiThera, a commercial stage medical device company, has completed the acquisition of Diopsys, a provider of modern visual electrophysiology medical devices, for an undisclosed sum.
The visual electrophysiology medical devices from Diopsys are intended to help eye care professionals study the entire pathway for visual and neuro-visual disorders.
