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FDA approves Novaliq's cyclosporine ophthalmic solution for treatment of signs and symptoms of dry eye disease


The water-free, preservative-free, anti-inflammatory drop from Novaliq, now coined Vevye, received FDA approval to treat the signs and symptoms of dry eye disease.

Image Credit: © megaflopp - stock.adobe.com

The immunomodulating solution fights inflammation with 0.1% cyclosporine A, resulting in an impressive tolerability profile. Additionally, the water-free formulation increases residual time on the ocular surface, improving bioavailability in the target tissues. (Adobe Stock / megaflopp)

The US Food and Drug Administration (FDA) has approved Novaliq’s cyclosporine ophthalmic solution (Vevye)—formerly known in development as CyclASol—for the treatment of the signs and symptoms of dry eye disease (DED).1

Vevye is a topical ophthalmic drug solution, which contains 0.1% cyclosporine A in EyeSol—a water-free technology that promotes cyclosporine A on the ocular surface with a high tolerability profile.2 It is the first water-free drug solution that does not require the use of preservatives, oils, or surfactants—all of which can cause irritation or disturbance to the tear film.3

“We are proud that [the] FDA approved Vevye. The safety and efficacy of Vevye were assessed in a total of 1369 patients with dry eye disease, of which 738 received Vevye. Vevye and its novel vehicle were safe, well tolerated, and demonstrated early, consistent, and durable therapeutic effects,” Sonja Krösser, PhD, vice president Medical Science & Regulatory Affairs at Novaliq, said in a news release.

“It is an exciting moment when you have followed science that finally led into a new category of water-free ocular therapies addressing unmet medical needs for patients suffering from dry eye disease.”

Based on 2 pivotal clinical trials, Essence-1 and Essence-2, the FDA accepted a New Drug Application (NDA) for Vevye in October 2022.4 In both trials, the cyclosporine ophthalmic solution demonstrated rapid onset of therapeutic effect, with patients reporting results within 2 weeks. The pharmaceutical company has plans to submit a Marketing Authorization Application in the European Union for the drug in July 2023.5

The immunomodulating solution fights inflammation with 0.1% cyclosporine A, resulting in an impressive tolerability profile. Additionally, the water-free formulation increases residual time on the ocular surface, improving bioavailability in the target tissues.

Anti-inflammatory options are the top choice for the treatment of DED, due to inflammation being the key underlying driver of the disease. The chronic inflammatory nature of dry eye disease can cause progressive corneal surface damage, which can negatively affect visual function—particularly in cataract and refractive patients.4

The trials

In November of 2017, Novaliq began conducting their first Essence phase 2b/3 clinical trial, which enrolled 328 patients across 9 clinical sites in the United States.6 The Essence-1 trial met its primary endpoint at 4 weeks, demonstrating an early onset of action in change from baseline on corneal fluorescein staining. The topline results were first presented in October of 2018.

Earlier this year, Novaliq released results from the Essence-2 study. The study was a randomized, double-masked, vehicle-controlled, clinical trial that assessed the efficacy, safety, and tolerability of water-free cyclosporine ophthalmic solution, 0.1%.

Essence-2  included 834 patients with moderate to severe DED who were randomized to active treatment (n = 423) or vehicle (n = 411) following a 14-day run-in period during which they instilled an artificial tear twice daily. The patients instilled either cyclosporine or vehicle twice daily for 29 days and the results were compared.

The study period ran from December 5, 2020, to October 8, 2021, at US 27 sites. The primary endpoints were the changes in the tCFS (0-15 [best to worst] on the National Eye Institute scale) and in the dryness score (0-100 [best to worst] on the visual analog scale) at day 29 compared with baseline. The investigators also evaluated the conjunctival staining, central corneal fluorescein staining, and the tCFS responders.

A key takeaway of the Essence-2 study was that after only 2 weeks of treatment, improvement was seen in the total and central corneal staining scores, which had persistent efficacy through day 29. Investigators emphasized that this rapid onset and magnitude of improvements of the corneal epithelial damage are potential differentiators to existing therapies for DED.

“An early onset of action, clinical significant efficacy on signs and symptoms and excellent comfort, as shown in the recent Phase 2/3 clinical Essence-1 trial, differentiates Vevye from existing therapies,” the company said on its website.5 “Results from the long-term extension study Essence-2 OLE confirmed that the effect of Vevye was maintained, and even improved for most endpoints, over the 52-week treatment period.

About Novaliq

Based in Heidelberg, Germany, and with offices in Cambridge, Massachusetts, Novaliq is a biopharmaceutical company with the intention of developing and commercializing first- and best-in-class ocular therapeutics. Their proprietary water-free technology EyeSol provides the basis for their research.

EyeSol leverages ultrapure semifluorinated alkanes (SFAs), which are physically, chemically, and physiologically inert. EyeSol maintains excellent biocompatibility and an impressive safety profile, and Novaliq is pursuing multiple pipeline candidates that leverage the platform in both ophthalmology and dermatology.

Novaliq is also associated with perfluorohexyloctane ophthalmic solution (Miebo; Bausch + Lomb, Novaliq), which is another water-free drop that was recently approved by the FDA. Both drops treat the signs and symptoms of dry eye, albeit using different tactics: Miebo targets tear evaporation whereas Vevye manages inflammation.

1. Novaliq announces FDA approval of Vevye (cyclosporine ophthalmic solution) 0.1%, for the treatment of the signs and symptoms of dry eye disease. Novaliq. Press release. June 8, 2023. Accessed June 8, 2023. https://www.novaliq.com/press-releases/2023/06/08/novaliq-announces-fda-approval-of-vevye-cyclosporine-ophthalmic-solution-0-1-for-the-treatment-of-the-signs-and-symptoms-of-dry-eye-disease/
2. Novaliq announces FDA acceptance of the new drug application for CyclASol® for the treatment of dry eye disease - Novaliq. Press releaseAccessed June 2, 2023. https://www.novaliq.com/press-releases/2022/10/24/novaliq-announces-fda-acceptance-of-the-new-drug-application-for-cyclasol-for-the-treatment-of-dry-eye-disease/
3. Novaliq Announces Publication of Second Pivotal Phase 3 Trial Data on CyclASol 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology. Press release. www.businesswire.com. Published April 12, 2023. Accessed June 2, 2023. https://www.businesswire.com/news/home/20230412005078/en/Novaliq-Announces-Publication-of-Second-Pivotal-Phase-3-Trial-Data-on-CyclASol-0.1-Cyclosporine-Ophthalmic-Solution-in-JAMA-Ophthalmology
4. Novaliq Plans to File a Markting Authorisation Application for CyclASol® in the E.U. for the Treatment of Dry Eye Disease in July 2023. Press release. Businesswire.com. Published February 8, 2023. Accessed June 2, 2023. https://www.businesswire.com/news/home/20230208005056/en/Novaliq-Plans-to-File-a-Markting-Authorisation-Application-for-CyclASol%C2%AE-in-the-E.U.-for-the-Treatment-of-Dry-Eye-Disease-in-July-2023
5. Novaliq announces positive topline results for its CyclASol® phase 2b/3 ESSENCE trial in patients with Dry Eye Disease - Novaliq. Press release. Accessed June 2, 2023. https://www.novaliq.com/press-releases/2018/10/17/novaliq-announces-positive-topline-results-for-its-cyclasol-phase-2b-3-essence-trial-in-patients-with-dry-eye-disease/
6. CyclASol - Novaliq. Accessed June 2, 2023. https://www.novaliq.com/products/cyclasol/
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