Just in time for Dry Eye Awareness Month, we look at some of the latest and upcoming breakthrough therapies for dry eyes that will change the treatment scene forever.
July 2023 is dry eye awareness month, and a new generation of topical drops are entering the arena one after another to meet unmet medical needs for patients suffering from dry eye disease.
Perhaps the most heralded of this crop is MIEBO™ (perfluorohexyloctane ophthalmic solution, Bausch + Lomb and Novaliq), the first dry eye drop which targets tear evaporation directly.
On the horizon, Tarsus Pharmaceuticals (California, USA) has submitted a New Drug Application (NDA) for TP-03 (lotilaner ophthalmic solution, 0.25%), a lipophilic solution which treats Demodex blepharitis by directly targeting the nasty mites that cause it.
Novaliq GmbH (Heidelberg, Germany) has also announced FDA approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol) — a water-free, non-preserved solution containing 0.1% cyclosporine A shown to reduce inflammation four weeks after beginning use. VEVYE received FDA approval on May 30, 2023 after its safety and efficacy were assessed in a total of 1,369 patients with dry eye disease, of which 738 received VEVYE. Its vehicle, EyeSol®, increases residual time on the ocular surface and enables a high bioavailability in the target tissues to unfold the full potential of cyclosporine.
“It’s kind of a combo drug with a vehicle that prevents evaporation of tears. We know that cyclosporine has a long history — 20 plus years in the United States, for being a safe, long-term treatment for dry eyes. It’s one of those powerful drugs for dry eyes, and together with this special vehicle which will be quite helpful, it’s going to be interesting to see how well this combo works,” noted renowned American ophthalmologist Dr. William Trattler.
Another exciting NDA awaiting action in November is Reproxalap (Aldeyra Therapeutics, Massachusetts, USA) — a first-in-class reactive aldehyde species (RASP) inhibitor that stops inflammation without the side effects of steroids.
“Reproxalap is a new class of topical therapy for dry eye, as it works at a different level of the anti-inflammatory pathway than current treatments, and is able to suppress inflammation,” commented Dr. Trattler.
“Steroids work very well in inhibiting inflammation in dry eyes. Yet, the RASP modulator are molecules targeting certain areas within the anti-inflammatory cascade that block inflammation and help treat the symptoms of dry eyes. It also has excellent results in allergic conjunctivitis. It is expected that this treatment will be very helpful for our dry eye patients when it gets approved in the US,” Dr. Trattler remarked. FDA action for Reproxalap is expected to be finalized by the end of December this year.
“I think it’s really exciting that we are having these new therapies coming on board because while our current therapies are very helpful for many patients, they are not curative. There are, of course, many patients that need more than what is currently available,” he continued.
Dr. Trattler explained that for the time being, ophthalmologists are often using monotherapy to treat dry eyes, “[w]e are using Xiidra (lifitegrast ophthalmic solution, 5%) or Cequa (cyclosporine ophthalmic solution, 0.09%) by itself, plus OTC treatments like artificial tears, warm compressors, or oral omega-3s. Now that all these new therapies are coming on board, it will elevate how we treat our patients,” he noted.
Moreover, eye care providers will be able to lay them on top of one another to optimize the treatment. “For example, we can have a patient on Cequa and then we can add a RASP inhibitor, or we may have a patient on MIEBO, then we add Xiidra,” he said.
All of this is great news for the growing legend of dry eye sufferers – making for potentially one of the most exciting Dry Eye Awareness Months in recent memory.
