Areas of Interest
BAND KERATOPATHY
Band Keratopathy is a calcific band in the cornea that causes extreme discomfort, pain, and impaired vision. Current standard of care is surgical debridement of the corneal epithelium, then using EDTA to remove the calcific deposits in the Bowman’s layer.
Annual Incidence in USA
< 100K
Clinical Phase
PHASE 3
SCHEDULED 2023
The image on the left displays a band-shaped, horizontal opacity that has grown from the peripheral cornea towards the central cornea.
FASTER APPROVALS
AN APPROVAL IN BAND KERATOPATHY WOULD LEAD TO EXPEDITED NDAs IN OTHER OCULAR INDICATIONS.
Livionex eye drops replace surgery
with daily dosing of an eye drop
Conducted successful pilot study at University of Rochester, NY
FDA agreement for single claim enabling 42-subject, 6-month dose duration Phase 3 clinical trial in USA
Active ongoing discussions regarding licensing with major pharmaceutical companies
CATARACTS
Cataracts are calcium lipid/protein aggregates that increase the opacity of the human lens and lead to impaired vision. It is the #1 cause of world blindness and 99% of all adults under 50 years of age get cataracts. It is the single largest line item in US Medicare budget. The current standard of care is surgery, reimbursed only for late-stage cataracts.
Diagnosed in USA
27.8M
Clinical Phase
PHASE 3
TO BE SCHEDULED
Opacity of the lens in early to moderate stage cataracts impairs vision significantly. Patients often see blinding lights and have foggy vision such as in the picture to the left.
#1
leading Cause of blindness globally
Cataract based vision loss starts around age 40, and the average age of surgery is 72 with vision loss increasing with each year. Typical symptoms of pre-surgical cataracts include significantly reduced vision especially in dim light, loss of color perception, and glare.
A multi-center FDA Phase I/II study showed that study subjects who dosed with the most efficacious eye drop dose for four months, showed an average 9 character gain in the ETDRS chart. For perspective, in patients with similar vision, cataract surgery showed a similar improvement of 9 characters using the same ETDRS chart.
eye drops target pre-surgical cataracts
(between 40 – 72 years)
A Phase I/II trial in early/moderate cataracts showed average vision improvement comparable to cataract surgery
A Band Keratopathy approval would accelerate the process to gain an additional cataract indication
In vitro and in vivo pre-clinical data shows that the eye drop may have efficacy in diabetic retinopathy and glaucoma