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New Drug Therapies for Dry Eye Disease, Demodex Blepharitis, & Meibomian Gland Dysfunction (MGD)
Dry eye disease is a chronic and progressive condition that significantly and negatively impacts patients and their loved ones. It is commonly one of the most under-diagnosed and undiagnosed conditions in eye care.
With tens of millions of patients suffering from dry eye disease in the US alone, innovation both diagnostically and therapeutically is welcomed and necessary.
At our advanced dry eye center, we commonly see patients who present with severe dry eye signs and symptoms including other ocular surface conditions such as blepharitis, MGD, eye allergies and ocular rosacea. Many of these patients have suffered for years with uncontrolled and frequent ocular symptoms leading to debilitating and severe flare-ups.
At Beverly Hills Optometry, our goal is to educate, empower, and restore hope for all our patients. Although there often isn’t one specific treatment option that provides complete relief, the use of combination therapies can help patients regain their lives.
Within the last decade, we have seen numerous breakthroughs in office-based treatments, at-home devices, and topical pharmaceuticals. Looking to the future, we have many promising options in the pipeline.
Novel FDA Drug Therapies pending approvals:
- TP-03 (Tarsus) is a topical ophthamlic eye drop (Lotilaner ophthalmic solution, 0.25%) used twice daily to help paralyze, eradicate, and exterminate demodex mites which ultimately improves patient symptoms. In their Phase 2b study, the TP-03 treatment essentially wiped out the infestation in more than 80% of patients after 43 days. Furthermore, in two pivotal studies (with 833 patients), TP-03 was deemed safe and well tolerated with no serious treatment-related adverse events. If approved, TP-03 may offer treatment for millions of patients with Demodex blepharitis. UPDATED in late-2023 (FDA APPROVED): XDEMVY Eye Drop
- NOV03 (B&L + Novaliq) is a potential first-in-class ophthalmic drug (100% perfluorohexyloctane) developed to treat dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 prevents excessive tear evaporation and restores tear film balance. This unique, investigational drug can penetrate the meibomian glands, dissolve thick meibum, and stabilize the lipid layer for hours. In two recent Phase 3 studies (GOBI & MOJAVE), NOV03 achieved significant improvement of signs and symptoms as early as 2 weeks with continued results through day 57. UPDATED in mid-2023 (FDA APPROVED): MIEBO Eye Drop
- CyclASol (B&L + Novaliq) is the first and only water-free cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease. CyclaSol is a fast acting and well tolerable dry eye drug therapy, demonstrating efficacy after only 4 weeks. The solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity.UPDATED in mid-2023 (FDA APPROVED): VEVYE Eye Drop
- AZR-MD-001 (Azura Ophthalmics) is a new potent ophthalmic keratolytic (selenium sulfide 0.5%), which decreases meibomian gland hyperkeratinization both at the gland orifices as well as within the ducts. Unhealthy, excessive protein (or keratin) buildup at the lid margin often blocks oil secretion, restricts outflow of meibum, and leads to dryness. AZR-MD-001 and its triple mechanism of action can: 1) slowdown of keratin production, 2) soften keratin by breaking down disulfide bonds, and 3) stimulate the quantity of lipids produced by the meibomian glands. In Phase 2 trials, patients produced healthier amounts of oil and had reduce dry eye symptoms.
- Reproxalap (Aldeyra) is a novel small-molecule drug candidate called RASP inhibitor (immune-modulating covalent inhibitor of reactive aldehyde species). Since RASP is a pro-inflammatory mediator, it is commonly elevated in the tear film of patients with dry eye disease. If approved, Reproxalap as a RASP inhibitor, may represent an alternative mechanism for diminishing ocular inflammation and uniquely address the needs of dry eye sufferers. As an investigational new topical drug, Reproxalap, has been studied in more than 1,800 patients with no adverse safety issues.
- AR-15512 (Aerie) is formulated to address the signs and symptoms of dry eye disease (DED) using a proprietary agonist of transient receptor potential melastatin 8 (TRPM8) cold thermoreceptor. TRPM8 cold-sensitive channels, found on the cornea and eyelids, create a cooling sensation across the eye which plays a role in maintaining the tear film homeostasis. Increased TRPM8 activity supports healthy basal tear production and blink rate, while a dysfunction in TRPM8 sensing may cause or worsen dry eye. In Phase 2b study (384 patients), patients demonstrated significant improvement in both signs and symptoms of dry eye disease in as early as 2 weeks.
- PL9643 (Palatin) is a first-in-class ophthalmic solution that treats signs and symptoms of moderate to severe dry eye disease. It is based on molecules that modulate the activity of melanocortin and natriuretic peptide receptor systems. The drug investigators explain that the melanocortin pathway works by resolving inflammation, promoting tissue healing, and maintaining immunologic homeostasis. A pivotal Phase 3 clinical study (MELODY-1) is underway to evaluate the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED. This study is based on positive Phase 2 results of PL9643.
With ocular surface disease on the rise, the introduction of these new drug therapies may serve useful to provide patients' added relief and limit the frequency and severity of flare-ups.