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  • CyclASol®

    CyclASol® changes the way eye care practitioners treat patients with dry eye disease.

  • CyclASol® is a topical anti-inflammatory and immunomodulating ophthalmic drug solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of dry eye disease.

  • EyeSol®, the unique water-free technology, unfolds the full potential of cyclosporine A on the ocular surface with an unprecedented tolerability profile.

  • CyclASol® demonstrated in multiple pivotal studies fast onset of therapeutic effect, clinical meaningful improvement of ocular surface damage and excellent tolerability.

  • On May 30, 2023 U.S. Food and Drug Administration (FDA) approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% is the first and only cyclosporine ocular therapy to treat both the signs and symptoms of dry eye disease. See www.vevye.com for more information and prescription information.

  • In August 2023 the European Medicines Agency (EMA) accepted Novaliq’s Marketing Authorization Application (MAA) for CyclASol® (ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease. The Committee for Medicinal Products for Human Use (CHMP) is currently reviewing the MAA under the centralized procedure for all 27 member states of the European Union (EU). Novaliq expects a positive CHMP opinion in 2024 folowed by approval.

Fast and powerful anti-inflammatory dry eye drug therapy

The unique water-free investigational drug increases residual time on the ocular surface and enables a high bioavailability in the target tissues to unfold the full potential of cyclosporine A and fast onset of action within 2 weeks.

The multi-dose, preservative-free, smaller and more physiologic drop size profile provides unique clinical benefits and outstanding tolerability.

An early onset of action, clinically significant efficacy on signs and symptoms and excellent comfort, as shown in the ESSENCE Phase 3 program, differentiates CyclASol® from existing therapies.

Results from the long-term extension study ESSENCE-2 OLE confirmed that the effect of CyclASol® was maintained, and even improved for most endpoints, over the 52-week treatment period.

Today anti-inflammatory therapeutic options are standard for care in DED. Inflammation is the key underlying driver of the disease as chronic immunologic processes have a pivotal role in the pathology of dry eye. The chronic inflammatory nature of DED also causes progressive corneal surface damage. Corneal surface damage can negatively affect visual function and any refractory eye care outcome in particular in cataract or refractive patients where dry eye is common.

Despite several anti-inflammatory therapeutic options approved, there is a large unmet need for a therapy that can rapidly and reliably repair corneal surface damage secondary to DED. Also better comfort is a high unmet need.

Regulatory Update CyclASol®

On May 30, 2023 U.S. Food and Drug Administration (FDA) approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% is the first and only cyclosporine ocular therapy to treat both the signs and symptoms of dry eye disease. See http://www.vevye.com for more information and prescription information. Harrow Acquired the U.S. and Canadian Commercial rights to VEVYE™ from Novaliq.

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol® (ciclosporin ophthalmic solution) for regulatory review in August 2023. Novaliq expects approval in 2024.

In 2023 Jiangsu Hengrui Pharmaceuticals Co., Ltd. received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8028 (cyclosporine ophthalmic solution) eye drops for the treatment of the signs and symptoms of dry eye disease was accepted by NMPA. SHR8028 was exclusively licensed to Hengrui for China in November 2019. The phase 3 study in China is published in JAMA Ophthalmology.

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Our products target key drivers of the disease and have constantly demonstrated significant improvement in sign and symptoms of dry eye in clinical trials.

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