Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Vevye is the first and sole cyclosporine solution specifically prescribed for addressing the signs and symptoms of dry eye disease with efficacy validated after four weeks of treatment.
“The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Sheppard, MD, MMSc, FACS, professor of ophthalmology at Eastern Virginia Medical School, and mid-atlantic medical director for Eye Care Partners and investigator in the development program.
“Vevye is an exceptionally well tolerated formulation, combining a novel, first-in-class vehicular delivery system with by far the most established and safe topical active pharmaceutical ingredient, cyclosporine, providing a major advancement for our patients,” added Sheppard.
Novaliq’s groundbreaking EyeSol technology, which utilizes proprietary water-free excipients, is widely recognized. These EyeSol substances demonstrate remarkable biocompatibility and do not accumulate in human tissues. Importantly, studies show that EyeSol-based formulations have a significantly longer residence time on the eye, lasting up to 240 minutes, compared to the relatively short duration of three to five minutes observed with traditional water-based eye drops.
Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. This innovative approach signifies a significant milestone in addressing the limitations of conventional eye care therapies.
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What Is Dry Eye Disease?
Dry eye disease, also known as keratoconjunctivitis sicca, is a complex condition that affects the ocular surface, characterized by an imbalance in the tear film and accompanied by symptoms such as ocular discomfort and visual disturbances. Inflammation of the ocular surface is a primary contributor to dry eye disease, which, if left untreated, can lead to progressive damage to the corneal surface and subsequent visual impairment.
Symptoms of dry eye disease can range from mild to severe, including blurred and fluctuating vision, eye discomfort, irritation, foreign body sensation, inflammation of the ocular surface, redness, excessive tearing and sensitivity to light. The prevalence of dry eye disease varies globally, ranging from 5 percent to 34 percent.
How Does Vevye Treat Dry Eye Disease?
Vevye (cyclosporine ophthalmic solution) 0.1 percent is an immunosuppressant in the class of calcineurin inhibitors, specifically developed for treating the signs and symptoms associated with dry eye disease. The medication is provided as a 2 mL sterile, clear, colorless, non-aqueous ophthalmic solution designed for topical use on the eye.
The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants. As a water-free product, it does not have an associated pH value or osmolarity. The key active ingredient, cyclosporine, functions as a selective immunomodulatory drug. By inhibiting calcineurin, cyclosporine effectively blocks the infiltration and activation of T cells, preventing the release of inflammatory cytokines. This mechanism reduces eye swelling and promotes tear production.
“Vevye addresses the well documented underlying inflammatory root cause of dry eye disease, repeatedly demonstrating early and clinically meaningful efficacy upon both signs and symptoms,” said Sheppard.
Safety and Efficacy of Vevye
The FDA’s approval of Vevye is solidly backed by robust clinical evidence. Two multicenter, randomized, well-controlled clinical studies demonstrated significant results in patients with dry eye disease treated with Vevye. These studies showed a statistically significant increase of ≥ 10 mm in Schirmer’s wetting in a higher percentage of eyes at day 29 compared to baseline. Specifically, approximately 10 percent of patients treated with Vevye experienced this improvement, compared to approximately 6 percent of patients in the control group.
Additionally, the clinical trials underscored the favorable tolerability profile of Vevye. Of the 738 subjects who received at least one dose of Vevye, the most common adverse reactions reported were instillation site reactions (8 percent) and temporary decreases in visual acuity (3 percent).
What is the Price of Vevye?
The exact cost of Vevye has not been publicly disclosed; however, it is estimated that the price of Vevye may be in the range of similar cyclosporine ophthalmic emulsions, such as brand-name Restasis that carries a list price of $645.63 for a 30-day supply (without insurance coverage). It is important to note that coverage for most cyclosporine ophthalmic products may be available through major insurance plans, subjective to specific insurance policies.
More Drugs for Dry Eye Disease Are on the Way
Several other drugs have recently gained FDA approval or are currently in advanced stages of clinical development for the treatment of dry eye disease.
One such approved medication is Miebo, an ophthalmic solution developed by Bausch + Lomb and Novaliq. Miebo contains perfluorohexyloctane as its active ingredient, a semifluorinated alkane that forms a protective layer over the tear film, reducing evaporation at the ocular surface. Clinical studies involving approximately 1,200 patients demonstrated that Miebo significantly improved eye dryness, as measured by a Visual Analog Scale, and enhanced the integrity of the ocular surface, as assessed by total corneal fluorescein staining.
In addition, Sylentis, a biotech company specializing in ophthalmic drugs and RNA interference (RNAi) technology, initiated a Phase III study in 2021. This study enrolled approximately 200 patients across 46 sites in the US and Spain to evaluate the safety and efficacy of their investigational product, tivanisiran, for the treatment of dry eye disease due to Sjögren’s Syndrome.
Tivanisiran is a preservative-free eye drop that uses RNAi technology, specifically gene silencing, to target and control the signs and symptoms of dry eye disease. By selectively inhibiting the production of transient receptor potential cation channels responsible for ocular pain transmission, tivanisiran aims to provide relief to dry eye disease patients. It is a small synthetic double-stranded RNA oligonucleotide (siRNA) designed for this purpose, representing the state-of-the-art in gene silencing technology.