We’re currently in a growth phase for pharmaceutical management of eye disease. In the last month, two companies announced positive Phase III results on novel drugs for dry eye/MGD and allergic conjunctivitis. The newest FDA-approved drugs include a drop for ptosis and dry eye flares, an infusion therapy for thyroid eye disease and a glaucoma implant. Getting to know these new meds can greatly improve your care of ocular disease patients.
Two Future Therapies
Bausch + Lomb, with partner Novaliq, announced top-line results from the first Phase III trial of NOV03. This perfluorohexyloctane agent works to solubilize lipids for the treatment of MGD and evaporative dry eye disease (DED). It achieved a statistically significant improvement over vehicle for both signs (total corneal staining) and symptoms (eye dryness score). Most impressive: improvement on both measures was noted as soon as day 15.
Even more recently, and closer to FDA approval, Aldeyra Therapeutics announced a novel allergy medication called reproxalap. Reactive aldehyde species levels are highly elevated in allergic conjunctivitis and dry eye disease. Positive, statistically significant top-line results from the Phase III clinical trial were observed in the primary pre-specified endpoint and all secondary endpoints. In the last 20 years, only the steroid Alrex has achieved a sign-and-symptom label for allergic conjunctivitis.
Eysuvis for Dry Eye Flares
Having an FDA approval for dry eye flares using this new agent from Kala in is not only significant in helping DED patients but also validates our long-standing approach to the management of this disease. The approval provides us an on-label loteprednol 0.25% eye drop for short-term therapy that improves dry eye signs and symptoms. In fact, 91% of patients on chronic immunomodulators admit to experiencing flares and the average dry eye patient has between four and six of such incidents per year.
Blepharoplasty in a Bottle
Shy of surgical options, there was little that could be done to improve the appearance or functioning of a ptosis. Upneeq (oxymetazoline 0.1%) was recently FDA-approved as a once daily drop for the treatment of acquired blepharoptosis. It is an α1 and partial α2 adrenergic agonist capable of contracting Müller’s muscle. The treatment elevated the upper eyelid about 2mm and statistically improved the superior visual field, making this therapy an effective nonsurgical treatment for upper lid ptosis.
Thyroid Eye Disease
Another 2020 approval was Tepezza (teprotumumab-trbw) from Horizon Therapeutics for the treatment of thyroid eye disease (TED). The treatment involves a series of eight infusions of a human monoclonal antibody and a specific growth factor receptor inhibitor. It is the only therapeutic for this indication. Prior to Tepezza, patients experienced the severe repercussions of Graves’ ophthalmopathy, including eye dryness, proptosis and eventual nerve compression, along with the negative cosmesis associated with TED. Decompression surgery is painful and difficult, so having a highly effective (though pricey) alternative treatment has done wonders for patients with TED.
The FDA also approved Allergan’s Durysta (bimatoprost) implant in 2020. An inserter placed at the limbus allows the eyecare provider to easily deliver a biodegradable, sustained-release glaucoma implant into the anterior chamber. The device sits in the lower angle and is evident for about three months before dissolving. What has been interesting is that a lowered IOP equivalent to using topical drops remains for between 18 and 24 months. This treatment is ideal for many patients, particularly those with dexterity issues or ocular surface disease.
There are numerous exciting and effective pharmaceuticals at our disposal, including new mechanisms of action and first-in-class therapeutics. They can greatly help our patients with ocular surface disease, glaucoma, TED and even ptosis. It’s time to get familiar with these new medications that go far in helping us effectively manage our patients.
Dr. Karpecki is medical director for Keplr Vision and the Dry Eye Institutes of Kentucky and Indiana. He is the Chief Clinical Editor for Review of Optometry and chair of the New Technologies & Treatments conferences. A fixture in optometric clinical education, he consults for a wide array of ophthalmic clients, including ones discussed in this article. Dr. Karpecki's full list of disclosures can be found here.