• Improved Dry Eye Drugs for 2022 and Beyond

    Nov. 04, 2021

    Few new treatment options have been introduced for dry eye disease, despite the fact that it’s one of the most universal and uncomfortable eye conditions.

    That’s one reason why nearly half of the 16 million Americans diagnosed with dry eye feel frustrated, according to a recent survey.

    Dry eye is an ocular surface disease (OSD)

    Dry eye is one of the most common ocular surface diseases, or OSDs. There are about a half-dozen OSDs, and each disease has a unique underlying cause — that's why one treatment doesn't work for everyone.

    Diagnosing and treating OSD can be tricky and time consuming. Patients usually need a combination of therapies, plus lifestyle changes, to bring effective and lasting relief.

    But often the treatments don't work right away or they sting, burn or irritate the eyes. That's why many patients stop taking their dry eye medication.

    “These side effects can be magnified in eyes already inflamed by an ocular surface disease like dry eye,” explains ophthalmologist and Academy spokesperson Christopher Starr, MD, a dry eye specialist at Weill Cornell Medical Center.

    New dry eye treatments may be more effective than existing ones

    For patients frustrated with their current treatment options, hope is on the horizon. Innovative drugs for OSDs of all kinds — including dry eye — are showing promise in clinical trials. Ophthalmologists are excited and optimistic about expanding their arsenal of treatment tools.

    Here's a rundown on what's currently available and what patients can look forward to in the next few years.

    Existing treatments for dry eye

    Current treatments for ocular surface disease include lifestyle changes, a nasal spray, punctual plugs, anti-inflammatory medications, deep-cleaning devices and specialized contact lenses.

    There are five FDA-approved prescription medications available today:

    • Tyrvaya (Oyster Point) — This much-anticipated nasal spray for dry eye was approved by the U.S. Food and Drug Administration in October 2021. The spray, a first of its kind treatment, stimulates tear, oil and mucin production. This nasal spray may be easier to apply than eye drops and it eliminates undesirable ocular stinging and burning sensations.
    • Restasis (Allergan) and Cequa (Sun Ophthalmics) — These medicines were developed specifically for chronic dry eye where inflammation leads to reduced tear production. The active ingredient is cyclosporine. Patients take one drop in each eye two times per day. The treatment can take 3 to 6 months to begin working, and may cause temporary burning or discomfort.
    • Xiidra (Novartis) — This is a different type of anti-inflammatory drop that uses lifitegrast as the active ingredient. This medicine can take up to 3 months to relieve symptoms, and up to a quarter of patients experience irritation and an unusual taste sensation.
    • Eysuvis (Kala Pharmaceuticals) — This is the first ocular corticosteroid (loteprednol) approved by the FDA for treatment of dry eye flares. It can only be used for 2 weeks at a time, due to the side effects of steroids. Patients take four drops a day in each eye. Eysuvis works more quickly than immunomodulator-based medicines, and both may be used in conjunction to alleviate symptoms. 

    New treatments for dry eye target the underlying problems

    Underlying inflammation

    Cyclosporine is not a new approach to treating dry eye. But MC2 Therapeutics and Novaliq are testing new cyclosporine-based anti-inflammatory treatments that may be more effective at treating this condition.

    Meibomian gland dysfunction

    Two new treatments may help people who lack enough healthy oils to keep their tears from evaporating too quickly. These oils are made by the meibomian glands along the edge of the eyelids. Therapies so far have been limited to eyelid scrubs, massage and warm compresses.

    • NOV03 (Bausch & Lomb) is a preservative-free eyedrop taken four times per day to stabilize tears and stave off evaporation. Patients in a phase 3 clinical trial experienced a rapid decrease in dryness after using the drops. This medicine could become the first FDA-approved prescription medication for this condition. 
    • AZR-MD-001 by Azura Ophthalmics is an ointment that prevents protein buildup in meibomian gland ducts. This buildup blocks oil secretion and leads to dryness. Patients who tested the medication in a phase 2 trial produced healthier amounts of oil and had reduced dry eye symptoms.

    Anterior blepharitis

    A ground-breaking medicine is in development to treat blepharitis caused by Demodex mites. These little bugs live harmlessly on virtually all people’s skin, but an overpopulation of them on the eyelids can lead to inflammation, crusting and itchiness.

    Demodex are believed to cause approximately half of all anterior blepharitis cases. So far, the only treatment options have been at home eyelid scrubs or in-office treatments with microblepharoexfoliation devices like the BlephEx.

    TP-03 by Tarsus Pharmaceuticals is an eyedrop administered twice daily that helps exterminate the mites and improve symptoms. In a phase 2b clinical trial, the treatment essentially wiped out the infestation in more than 80% of patients after 43 days. This therapy could become available as early as 2022. 

    Allergic conjunctivitis

    Dry eye often exists alongside allergic conjunctivitis, leading to red, swollen, itchy or watery eyes. Doctors often prescribe eyedrops containing antihistamine or steroids. These treatments aren't ideal: Steroids can increase eye pressure and raise the risk of infection and cataracts if used for long periods of time. And allergic conjunctivitis and dry eye are often chronic conditions, requiring long-term treatment.

    Two new therapies may offer better options for people with allergic conjunctivitis.

    • Reproxalap by Aldeyra Therapeutics is a new anti-inflammatory treatment without the common side effects of steroids. In a phase 3 clinical trial, patients who received the medicine 4 times per day for 12 weeks experienced improvements in dryness, redness and itching within hours of beginning treatment. They had minimal side effects. This therapy may become available in the next couple of years. 
    • Another non-steroid anti-inflammatory called IC 265 by Iacta Pharma is also showing potential to treat chronic eye allergies. In a phase 2 trial of patients with allergic conjunctivitis, the medicine reduced redness and inflammation within hours and was well-tolerated. Next up: The treatment will be tested in patients with dry eye disease.

    Anterior uveitis

    An anti-inflammatory treatment may prove effective for both dry eye and anterior uveitis. Uveitis refers to a group of inflammatory diseases that produces swelling and destroys eye tissue. These conditions are normally treated with corticosteroid drops, injections or pills — not ideal for long-term use. 

    OCS-02 by Oculis is a topical medication that may effectively reduce uveitis inflammation and relieve discomfort caused by dry eye, according to a phase 2 clinical trial. The treatment was well tolerated without causing steroid-type side effects. It will continue to be tested in future trials. 

    “Having a wider breadth of options targeting more of the subtypes of dry eye and ocular surface disease will help ophthalmologists to better customize treatments. This should lead to greater efficacy and faster symptom relief for patients,” says Dr. Starr.