In 2019, we have access to two exciting new therapies
This past year brought some significant advances in eye care as far as new tests, technology, and drug approvals, and 2019 is looking just as promising. In 2018, we gained access to the first two new glaucoma drugs in decades. Now two more new drugs will soon be available to us. These include a new ocular corticosteroid that uses a revolutionary drug delivery technology, and a new drug that treats a rare and progressive eye disease that can lead to corneal scarring and vision loss. Here’s why I’m looking forward to trying these new therapies in my practice.
New post-ocular surgery drug uses nanotechnology
The FDA has approved Inveltys (Kala Pharmaceuticals), the first and only twice-daily ocular corticosteroid for the treatment of inflammation and pain after ocular surgery. The drug is a 1% concentration of loteprednol a proprietary drug delivery nanotechnology, called AMPPLIFY™, involving mucus-penetrating particles (MPPs) that allow the active drug to penetrate into the target tissues of the eye.
Mucin is actually a protective barrier on many tissue surfaces, including the eye. It prevents allergens, virus, and bacteria–but also drugs–from penetrating to the target tissues. This MPP technology uses a combination of selectively sized nanoparticles and non-covalent proprietary coatings to allow the drug to distribute evenly on the mucosal surfaces and increase drug delivery to the cornea, conjunctiva, etc.
The FDA has approved the first ocular corticosteroid for BID dosing; clinical trials showed a significant change in inflammation in patients.
Inveltys is the first ocular corticosteroid approved for BID dosing (two times a day) post-cataract surgery, rather than the four-times-a-day dosing approved for previous post-surgical corticosteroids.
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Pivotal clinical trials showed a significant change in inflammation as measured by percentage of patients with complete resolution of anterior chamber cells and pain as measured by patient response. I’m looking forward to trying this new drug and seeing its efficacy and the likely relatively good safety profile.
Breakthrough treatment for rare corneal disease
This year, we should also have access to a new drug called Oxervate (Dompé), a breakthrough therapy indicated for the treatment of neurotrophic keratitis, a condition that results from impaired function of corneal nerves. While rare (affecting fewer than 65,000 people in the U.S.), this progressive eye disease can lead to corneal scarring and vision loss. Neurotrophic keratitis is observed in patients who have had HSV keratitis or herpes zoster ophthalmicus, diabetes, or longstanding ocular surface conditions such as keratoconjunctivitis sicca (KCS).
A new breakthrough therapy targets hard-to-treat, disabling corneal nerve disease, neurotrophic keratitis.
“Neurotrophic keratitis can be disabling, hard to treat, and many patients do not respond well to existing therapies,” which are limited to surgical interventions and symptomatic treatment, said Reza Dana, professor of ophthalmology at Harvard Medical School, director of the Cornea Service, senior scientist at the Massachusetts Eye and Ear, and Dompé medical advisor.
Oxervate 0.002% ophthalmic solution is based on cenegermin-bkbj, a recombinant form of human nerve growth factor (rhNGF), and is structurally similar to the nerve growth factor (NGF) protein that is made in the human body, including in the ocular tissues. NGF is involved in the differentiation and maintenance of neurons. These neurons act through high-affinity (i.e., TrkA) and low-affinity (i.e., p75NTR) nerve growth factor receptors in the anterior segment of the eye.
This new drop would support corneal innervation and integrity. Healing the nerves is essential to healing the eye/cornea in numerous neurotrophic conditions, including persistent epithelial defects and persistent SPK. It will be interesting to see if this may affect patients who are afflicted with neuropathic corneal pain, but that remains to be studied.
In the pivotal clinical trial for FDA approval, 72 percent of patients treated with Oxervate had complete corneal healing, defined as absence of staining of the corneal lesion and no persistent staining in the rest of the cornea after eight weeks of treatment; 80 percent of these patients remained healed after one year. The results were significant for Oxervate compared to placebo, making this new drug well worth trying for patients with neurotrophic keratitis.