Combines Extensive Contact Lens & Pharma Experience
Glaucoma affects about 66.8 million people worldwide, leaving 6.7 million with bilateral blindness 59,60. The financial impact of glaucoma on the US economy is more than $1.5 billion annually 61. Glaucoma is managed through intraocular pressure (IOP) lowering medications, delivered through eye drops, which suffer from many deficiencies, including poor compliance. We have shown both in animal and human studies that by wearing contact lenses for just one or two days, the IOP reduction persists for a week or longer. As a result, we are designing a contact lens-based therapy in which patients will wear the lens for a day followed by 6 days in which there will be no need for any therapy. This works with contacts because high bioavailability results in creation of drug depots in the eye that can continue to deliver drug to the target tissue after the lens is removed.
Additional benefits are summarized below.
Contact lenses eliminate or reduce the daily peaks and troughs associated with eye drops. The relative risk of disease progression within 5 years of diagnosis increases from 1.0 to 5.76 with an increase in IOP fluctuations from 3.1 to 5.4 mm Hg 62. The continuous release from contacts will minimize IOP fluctuations which could reduce the risk of disease progression.
By delivering multiple drugs from the same contact lens and reducing the frequency needed for therapy, compliance can be improved. Compliance is low for eye drop self-administration 10–23 with <50% for single glaucoma eye drops, and even lower for multiple drops 16–23.
Contact lens use is becoming more common in glaucoma population. About 1.5-2% of Americans in 40-49 years age group suffer from glaucoma 63 and in this group 15-20% wear contacts 64. Additionally, baby-boomers wish to continue wearing contacts as they get older 65. Due to advances in multifocal technologies, material design and fitting techniques, age is no longer necessarily the determining factor for contact lens success 66. A recent survey of 99 glaucoma treating ophthalmologists showed that 88.9% of doctors would you consider using a sustained-release drug-eluting contact lens as a glaucoma treatment modality and 87.9% thought that patient adherence could be improved by prescribing a drug-eluting contact lens that has the ability to also correct refractive errors 67.
Contact lenses are ideal for delivering combination therapy which is increasingly becoming common for glaucoma patients. Even two incompatible drug molecules can be delivered in the same contact lens by distinct placement of the drug in the lens.
Contact lenses are single-use devices and there is no need for preservatives, compared to eye drops which typically contain preservatives that are known to cause toxicity 68,69. About 20% of glaucoma patients suffer from the dry eye disease (DED) 70, and by eliminating the preservative benzalkonium chloride (BAK) from the eye drops, the clinical finding of corneal staining, a diagnostic criteria for DED, was reduced by 35% 71. Ocusert® (Alza), a pilocarpine loaded cul-de-sac insert was more effective than eye drops as it produced a constant reduction in IOP for over 7 days 29 with 1/8th of the eye drop dose 30. Unfortunately, Ocusert® has been discontinued due to retention problems and manufacturing issues 31. Contact lenses do not suffer from these issues as millions of people wear lenses without retention problems and companies have developed efficient high throughput manufacturing to produce contact lenses inexpensively.
Glaucoma affects about 66.8 million people, leaving 6.7 million with bilateral blindness 1,2. The financial impact of glaucoma on the US economy is more than $1.5 billion annually 3. Glaucoma is managed through intraocular pressure (IOP) lowering medications, delivered through eye drops, which suffer from many deficiencies including poor compliance. We have shown both in animal and human studies that by wearing contact lenses for just one or two days, the IOP reduction persists for a week or longer. So, we are designing a contact lens based therapy in which patients will wear the lens for a day followed by 6 days in which there will be no need for any therapy. This works with contacts because high bioavailability results in creation of drug depots in the eye that can continue to deliver drug to the target tissue after the lens is removed.
Additional benefits are summarized below.
Based on a recent report of Future Market Insights (FMI) the global corneal ulcer treatment market will grow at an annual growth rate of more than 5.5% during 2019-2029 to reach about US$ 1 Bn mark by 2029 end [https://www.bloomberg.com/press-releases/2020-02-13/corneal-ulcer-treatment-will-create-a-billion-dollar-market-by-2029-antibiotics-to-remain-leading-drug-category-proj]. The report had the following key takeaways for the corneal ulcer treatment market:
* Antibiotics will remain the leading drug category, with a projected revenue share of 77% in 2029.
* Antifungals are set to exhibit promising growth in sales during the forecast period.
* Eye drops continue to be a preferred form of corneal ulcer treatment.
* About 50% of corneal ulcer treatment drugs are distributed through retail pharmacies.
* Bacterial keratitis will remain a prevalent form of corneal ulcer during the forecast period.
* North America to remain a lucrative regional market for corneal ulcer treatment.
Based on the report, these are the main growth drivers:
* Increasing number of clinical trials targeting development of cost-effective treatment options will fuel market growth.
* Improving research funding and enhanced epidemiological knowledge are major growth levers for market.
* Emergence of alternative treatment methodologies such as dual therapy is driving the demand.
Our immediate focus is on treatment of microbial keratitis though the treatment will be effective for all bacterial ulcers. We also plan to develop contact lenses for antifungal therapy (natamycin loaded lenses) to play in both the antibacterial and antifungal segments. Our technology also affords the possibility of release of multiple drugs which could be very useful for the treatment of corneal ulcers.