Keep the riffraff out: Novel dry eye treatments emerge
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In the field of ophthalmology and optometry, dry eye disease has been anything but delightful, fun or mesmerizing.
Despite a huge increase in armamentarium to help the ocular surface, many premium surgeons just do not have the time that is needed to deal with patients with dry eye. As we know, untreated ocular surface disease can affect visual outcomes in any of our refractive and refractive cataract procedures. Some practices, including my own, have created elite dry eye treatment centers of excellence or “spas,” staffed by eye care specialists in dry eye. The problem remains that there is still no real cure for dry eye.
There are many approaches and algorithms to treat inflammation and meibomian gland obstruction, most of which are too complicated for even the most experienced premium surgeon. The good news is that newer products are arriving to help keep the riffraff away from the ocular surface sooner in the process. In my opinion, these newer approaches may be the start of curing dry eye disease altogether.
Reproxalap
Reactive aldehyde species (RASP), as implicated in inflammatory ocular surface disease, are most well characterized by malondialdehyde (MDA). MDA levels are elevated in the tears of patients with dry eye disease. Reproxalap (Aldeyra Therapeutics) is a first-in-class novel RASP inhibitor currently being investigated in phase 3 clinical trials for dry eye disease and allergic conjunctivitis. The good news is RASP inhibitors keep the riffraff out early by working quickly and efficiently at the top of the inflammatory cascade at a level even before topical steroids take effect.
A randomized, double-masked phase 2a clinical trial showed clinically significant improvement in SANDE symptom scores at day 28, and improvements were seen as soon as 1 week after beginning treatment. MDA levels in the tears of patients in the trial were statistically lower after 28 days of therapy compared with baseline, and these reduced MDA levels correlated with improvements in tear osmolarity and lissamine green staining as well. A phase 2b trial met the 12-week dryness symptom and ocular redness endpoints. The topline phase 3 TRANQUILITY results showed statistically significant improvement in 10 mm or greater increase in Schirmer tear production after 1 day of dosing with topical preservative-free reproxalap. The acute improvement in signs and conjunctival redness and chronic symptom relief with this new treatment are a paradigm shift in dry eye disease therapy.
NOV03
Bausch + Lomb and Novaliq have publicly announced statistically significant topline data from the phase 3 GOBI trial evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class drop with a novel mechanism to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction. The primary endpoints of total corneal fluorescein staining and eye dryness score using the visual analog scale were both met at day 15, again early on keeping the riffraff out. NOV03, used four times daily, is a proprietary aqueous-free, preservative-free solution based on Novaliq’s patented EyeSol technology.
Tyrvaya
The last way to keep the riffraff out is by using a nasal spray. Tyrvaya (varenicline solution 0.03 mg, Oyster Point Pharma), approved by the FDA in October 2021, works in a different way, with the preservative-free solution activating the trigeminal parasympathetic pathway via the nose, resulting in increased basal tear production and restoration of tear film homeostasis. Tyrvaya is approved to treat both the signs and symptoms of dry eye, as it was studied in more 1,000 patients with mild, moderate and severe disease. The ONSET-1 and ONSET-2 pivotal trials showed results out to week 4, and the MYSTIC trial showed improvement in signs alone out to 12 weeks. The most common adverse reaction is sneezing (82% of subjects sneezed at least once in the clinical trials), and the majority (98%) reported sneezing as mild; 65% of subjects in ONSET-2 reported the sneezing resolved within 1 minute. No participants discontinued Tyrvaya due to sneezing.
In summary, dry eye disease is a problem for premium surgeons, and keeping the riffraff out early will make us surgeons and our patients a lot happier in the end. Now let’s get rid of the COVID riffraff once and for all. Stay healthy all.
- References:
- Clark D, et al. Am J Ophthalmol. 2021;doi:10.1016/j.ajo.2021.01.011.
- Clark D, et al. J Ocul Pharmacol Ther. 2021;doi:10.1089/jop.2020.0087.
- Dieckmann G, et al. Ocul Surf. 2019;doi:10.1016/j.jtos.2018.11.002.
- Labetoulle M, et al. Acta Ophthalmol. 2019;doi:10.1111/aos.13844.
- For more information:
- Mitchell A. Jackson, MD, can be reached at Jacksoneye, 300 N. Milwaukee Ave., Suite L, Lake Villa, IL 60046; email: mjlaserdoc@msn.com.
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