Treating Demodex blepharitis is challenging. Lid scrubs with baby shampoo, warm compresses, and combination steroid-antibiotic ointments and oral treatments can help to alleviate symptoms, but none of these are toxic to Demodex folliculorum mites, which are implicated as the cause of blepharitis in 45% of cases.1 Persistent and chronic Demodex blepharitis can lead to a variety of conditions, including allergy, inflammation, lash loss and misdirection, telangiectasia, and decreased visual acuity.
Luckily, a new treatment is on the horizon that can help to kill Demodex. TP-03 (Tarsus Pharmaceuticals) is a topical drug that kills the mites by targeting their nervous system. To date, consistent results have been shown with TP-03 across four phase 2 studies and more than 100 patients. It is being developed in a multidose preserved formulation.
In the single-arm, open-label Mars phase 2a study to evaluate the safety and efficacy of TP-03, 15 patients with Demodex blepharitis received one drop of the treatment in each eye b.i.d. for 28 days. Beginning at day 14 and continuing throughout the 90-day study period, TP-03 statistically significantly decreased the mean collarette score and mite density. Specifically, a 2-grade improvement on a four-point collarette score scale and a 10-fold improvement in mite eradication were demonstrated by the end of the 28-day treatment period.
No adverse events were reported, and there were no clinically significant changes in visual acuity, IOP, or slit-lamp biomicroscopy findings. Further, the use of TP-03 over the 4-week period was well-tolerated, with no patient discontinuing its use due to tolerability issues.
TP-03, in my opinion, is going to be a game-changer. Patients with Demodex blepharitis are historically hard to treat because the condition is persistent and the therapies we currently have—mainly lid scrubs, warm compresses, and even combination steroid-antibiotics—do nothing to treat the underlying cause.
If we can kill the Demodex folliculorum mites, we can help our patients to achieve increased comfort and to maximize their visual acuity. This is important to all patients, but especially to our premium IOL patients who have high expectations for their visual outcomes. A pharmaceutical agent that can rapidly, completely, and effectively treat Demodex blepharitis and that is well-tolerated and safe is severely needed. TP-03 is a promising new agent to fulfill that need.
Results from the phase 2b randomized controlled Jupiter study will be forthcoming.
By Ehsan Sadri, MD, FACS, FAAO