By Denis Langlois
Johnson & Johnson Vision is working to develop an antihistamine-releasing contact lens that’s aimed at correcting vision, while reducing eye itch from allergies.
Phase 3 clinical study results, published in the journal Cornea, have demonstrated that patients wearing the investigational contact lens – daily disposable lenses containing ketotifen, a drug that inhibits certain substances that are known to cause allergic reactions and inflammation – had lower mean itching scores after their eyes were exposed to allergens compared to those wearing non-medicated control lenses.
Following on the Cornea publication, additional data from an initial proof of concept study involving two different doses of the antihistamine ketotifen was presented at this year’s Association for Research in Vision and Ophthalmology annual meeting in Vancouver, B.C. This trial provided the basis for additional studies, including the Phase 3 pivotal trials which were the first large-scale studies to evaluate a contact lens-based drug delivery system.
Optical Prism recently spoke with Brian Pall, Director of Clinical Science at Johnson & Johnson Vision Care and the lead author of the manuscript, about the investigational lenses and what’s next.
- Please explain the impact of ocular allergies on patients and why it is important to Johnson & Johnson Vision to find ways to help people with this condition?
- More than 20 percent of the population experience ocular allergy, or itchy eyes, and the condition can have a significant impact on productivity or quality of life. Contact lens wearers are particularly impacted by ocular allergies, so we are very pleased to have reached this important research and development milestone.
The primary symptom of ocular allergy is indeed itch – with eye-rubbing causing both an exacerbation of allergic symptoms and risk to disrupting the ocular surface or damaging a person’s contact lenses.
Often contact lens wearers resort to suffering through or removing their lenses which is never good if contact lenses are their preferred way to correct their vision.
Given the unmet need, Johnson & Johnson Vision is continuing to develop what could be an entirely new category of contact lenses – a contact lens combined with an antihistamine. We’ll continue to progress this pioneering work in hopes of one day offering a new solution.
- In countries like Canada, what are the common causes of ocular allergies?
- Common causes are quite consistent across the world. Ocular allergy can be seasonal or perennial and occur when people are exposed to allergens such as tree or grass pollen, pet dander or dust. Some of the worst allergy-inducers in Canada more specifically are related to trees that shed airborne pollen, including ash, alder, birch, cedar, elm, oak and walnut, but these along with variable weeds can vary based on the part of the country you may be in.
- What were the highlights from the latest trials for J&J’s investigational antihistamine-releasing
- The Phase 3 data published in Cornea showed both a clinically and statistically meaningful reduction in itchy, allergy eyes with the antihistamine-releasing contact lenses compared to non-medicated lenses. These large-scale studies represent the first time that contact lens-based technology has shown the potential to correct vision and reduce the occurrence of eye itch from allergies.
The two multi-center, randomized, placebo-controlled studies included 244 patients and used the conjunctival allergen challenge model (Ora-CAC®) as a replicable measure to assess the efficacy of the investigational contact lens. Reduction in ocular itching was reported as quickly as 15 minutes after lens insertion and lasted for the full duration of the study evaluation period, which was 12 hours.
Secondary endpoints in the trials evaluated the reduction in eye redness, but did not demonstrate a clinically significant reduction in people wearing the antihistamine-releasing lenses. Both the antihistamine-releasing contact lenses and the control lenses demonstrated a low rate ocular adverse events (4.9% overall) with the majority being mild and not considered study related. Additionally, there were no discontinuations from study treatment based on any ocular adverse events.
- What are the next steps for the testing/trial stage for this proposed product?
- We are encouraged about the recent data publication and results and are continuing to develop the investigational antihistamine-releasing contact lens as a potential new category of contact lenses.
We continue to progress this pioneering work in hopes of one day offering a new solution.