Novaliq Submits New Drug Application to FDA for CyclASol® (Cyclosporine Ophthalmic Solution) for the Treatment of Dry Eye Disease

Heidelberg, Germany and Cambridge, MassachusettsAugust 9, 2022PR Newswire -- Novaliq, a biopharmaceutical company focusing on first-class ophthalmic therapies based on the unique EyeSol® water-free technology, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of CyclASol® (cyclosporine ophthalmic solution). CyclASol® is a new therapy proposed for the signs and symptoms of dry eye disease (DED).

In two pivotal studies, CyclASol® demonstrated rapid therapeutic effects, clinically meaningful improvements in ocular surface damage, and excellent tolerability within its indicated use. Results from the 12-month long-term study confirmed that the effects on most signs and symptom endpoints were maintained or even improved.

"Novaliq CEO Christian Roesky, Ph.D., stated, 'This is the first submission in a new class of anhydrous topical drug treatment products utilizing EyeSol® as a drug carrier. CyclASol® is a first-of-its-kind drug therapy aimed at expanding treatment success for dry eye disease patients and their eye care professionals. If approved by the FDA, CyclASol® could address a significant unmet medical need in DED through its ocular surface healing effects and high comfort administration.'"

Dry eye disease (DED) is one of the most common ocular surface diseases, with approximately 18 million Americans diagnosed with DED.^1,2Inflammation and immune processes play a key role in the pathogenesis of this disease.

Ocular surface damage secondary to DED may also affect refractive measurements prior to corneal refractive surgery and ultrasonic refractive surgery, and have an adverse impact on the expected visual outcomes following these procedures.^3,4 The impact of DED-induced corneal surface damage on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treating corneal surface damage before ophthalmic surgery. There remains a significant unmet need for drugs with better tolerability and earlier onset of therapeutic effects, and the use and prescription of such drugs are compelling.^5,6

"We are honored to see another product quickly enter the market, marking another significant turning point and milestone in Novaliq's growth trajectory," said Mathias Hothum, member of the dievini board and managing director. "We are currently evaluating commercialization strategies, including dialogues with stakeholders."

AboutCyclASol®
CyclASol® is a first-of-its-kind topical therapy containing cyclosporine (a potent anti-inflammatory and selective immunomodulatory drug). Although cyclosporine is not water-soluble, it is soluble in the EyeSol® excipient perfluorobutylpentane, which achieves better bioavailability and efficacy for the targeted tissue. The product is free of oil and surfactants. Due to its novel carrier, it is also preservative-free. This provides patients with additional clinical benefits, such as improved tolerability and reduced visual disturbances.

The NDA is supported by safety and efficacy results from more than 1,000 DED patients in the Phase 2 dose-finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study, and the open-label extension study.^7,8

In two independent, adequate, and well-controlled multicenter studies (ESSENCE-1 and ESSENCE-2), CyclASol® demonstrated clinically meaningful and statistically significant improvements in the indication.

Effects on the Ocular SurfaceIncluding a statistically significant reduction in total corneal fluorescein staining (tCFS) scores, both studies at Day 15 and Day 29 showed favorable results for CyclASol®. Up to 71.6% of patients experienced relief within 4 weeks, with clinically meaningful improvement (≥ 3 grades) in total corneal staining. In both studies, this proportion of responders was significantly higher compared to patients receiving vehicle treatment. Responders also demonstrated statistically significant improvements in various symptoms compared to non-responders at Day 29. The ASCRS guidelines consider corneal staining as one of the most important clinical signs of DED, as it indicates the extent of epithelial damage and visual impairment, and if inadequately treated, DED may become chronic and more difficult to treat.³

Effect on Tear Production: In these two studies, a statistically significantly higher proportion (p<0.05) of patients had increases of more than 10 mm from baseline in Schirmer tear test scores on Day 85 and Day 29 compared to the vehicle at the end of treatment. Meeting this endpoint in two independent studies is clinically meaningful in itself and is considered proof of efficacy in treating the signs and symptoms of DED.

Head-to-Head DataComparison with the Phase 2 study of Restasis™ showed that CyclASol® has a stronger and faster therapeutic effect on the ocular surface.⁸

EffectMaintainThe results of the CYS-005 long-term study confirm that the effect of CyclASol® was maintained over the 52-week treatment period, with even improvement observed in most endpoints.

Safety and Tolerability:The tolerability of CyclASol® was demonstrated by high patient-reported comfort scores in both studies. The most commonly observed adverse reaction was instillation site reactions, reported by 8.1% of patients in the pooled studies. Except for one case, all were mild. The only other adverse reaction reported in more than 2% (2.7%) of patients was decreased visual acuity.