The battle against dry eye received a fillip with three recent announcements regarding new treatments:
- The first is Systane iLux2 Meibomian Gland Dysfunction (MGD) Thermal Pulsation System, which was recently launched by Alcon.
- The second is a pharmacological treatment 0.25% Reproxalap ophthalmic solution from Aldeyra Therapeutics, which has just completed enrollment of the phase 3 TRANQUILITY-2 trial.
- And the third, is the real-world study PERSPECTIVE which showed that ciclosporin A 0.1% cationic emulsion significantly reduces signs and symptoms of dry eye disease (DED) patients.
A Pernicious Problem
According to the Dry Eye Disease Directory, “up to 49 million Americans have dry eye disease and dry eye treatments globally are set to cost 6.6 billion dollars by the end of 2027.” Sometimes known as dysfunctional tear syndrome, dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms.* If left untreated DED can cause complications such as corneal ulcers, headaches, conjunctivitis and depression, as well as otherwise detracting from a patient’s quality of life. But help is at hand.
First up to help is Alcon’s Systane iLux Meibomian Gland Dysfunction (MGD) Thermal Pulsation System. While it won’t win any awards for having a snappy name, it will take snaps of patients’ meibomian glands, along with glorious HD video. This provides patients with more insight into their treatment needs and helps to visualize therapeutic choices. With results in 8-12 minutes, this new device could help ophthalmologists better match treatment to patients’ needs.
Ready to Roll: Phase 3 Begins
Good news for DED patients: Aldeyra Therapeutics has announced completion of enrollment in the phase 3 TRANQUILITY-2 trial of 0.25% reproxalap ophthalmic solution in patients with DED. Prior phase 2 clinical trials showed that TRANQUILITY-2 is 90% powered to detect statistically significant differences both in ocular redness and Schirmer test endpoints. The goal is to complete new drug application (NDA) criteria demonstrating improvement in signs of dry eye disease. According to the FDA guidelines, potential new products must show efficacy in an objective sign in at least two clinical trials and efficacy in a subjective symptom in at least two clinical trials. To meet these requirements, Aldeyra plans to submit two previously completed 12-week symptom trials: the phase 3 RENEW-Part 1 trial and the Formulation phase 2. Aldeyra hopes to submit TRANQUILITY-2 for NDA in mid-2022.
A New Perspective on Dry Eye Treatment
Santen EMEA has revealed the results of a new real-world, evidence-based study, PERSPECTIVE, which assessed the long-term treatment of severe keratitis in DED patients. The multicenter study, which encompassed 44 ophthalmology clinics in five European countries, showed the efficacy of ciclosporin A (CsA) 0.1% cationic emulsion (CE).
“Dry eye disease is a complex and chronic condition that can be very challenging to diagnose and treat. It requires long-term management and if left untreated can result in permanent ocular damage,” Professor Geerling from University Hospital Düsseldorf said in a press release. “The PERSPECTIVE study has not only shown that ciclosporin A 0.1% cationic emulsion is well tolerated, but that all findings were consistent with previous clinical studies.”
The Results are In
PERSPECTIVE’s year long observational study of 472 patients (75.9% female) from the U.K., Norway, Sweden, Finland and Germany tested the safety, toleration and effectiveness of CsA 0.1% CE in DED patients whose treatment had not improved with artificial tear (AT) products. The primary endpoint was mean standard deviation change from baseline in corneal fluorescein staining (CFS; Oxford Grade Scale) at month 12. Ocular sign and symptom severity and adverse events (AEs) were the secondary endpoints.
PERSPECTIVE found that CFS score reductions were statistically significant from week 4 and incrementally decreased through to 12 months:“Mean (SD) CFS score at month 12 was 1.10 (1.13), representing a statistically significant mean (SD) change from baseline (2.56 [1.10]) of 1.42 (1.16; P<0.0001).”
The results also showed that eyelid erythema and conjunctival erythema against baseline showed significant reduction in severity, from week 4 to month 12. Tear film break up time was significantly increased week 4 to month 12. Tolerability was good and matched previous clinical findings. In total 101 treatment AEs were reported; 83.6% were considered mild or moderate and 73.3% were resolved by month 12.
In a press release, Dr. Ioana Grobeiu, vice president of Medical Affairs at Santen EMEA said: “The PERSPECTIVE study demonstrated significant reductions in the severity of symptoms, including foreign body sensation, burning, stinging, itching, eye pain, blurred vision and photophobia from week 4, that were sustained through to month 12. The findings of this study represent a positive step forward in how the signs and symptoms of this chronic disease can be managed.”
*Craig JP, Nelso JD, Azar DT, et al. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017;15(4):802-812.