HEIDELBERG , Germany , and CAMBRIDGE, MA , Aug. 9, 2022 /CNW/ — Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) seeking authorization for CyclASol® (cyclosporine ophthalmic solution), the proposed novel treatment for the signs plus symptoms of dry eye disease (DED).

Novaliq GmbH Logo

Novaliq GmbH Logo

CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement associated with ocular surface damage, in addition to excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints.

“This is the first distribution of a novel product category of water-free topical drug therapies utilizing EyeSol® as a drug carrier”, said Christian Roesky , Ph. D., CEO, Novaliq. “CyclASol® is a first-of-a-kind drug therapy and even aims to expand treatment success with regard to patients with dry eye disease and their vision care professionals. If approved by the particular FDA, CyclASol® addresses important unmet medical needs inside DED through its ocular surface healing effect combined with high comfort of administration. ”

Dry eye is one regarding the most common ocular surface area disorders, along with approximately 18 million Americans diagnosed together with DED. 1, 2 Inflammation together with immunologic processes play a new key role in typically the pathology involving the illness.

A compromised ocular area secondary in order to DED may also compromise refractive measurements before keratorefractive and additionally phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries. 3, 4 The impact of the corneal surface damage secondary to be able to DED upon visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains regarding better tolerated drugs using an early onset connected with therapeutic effect, which are compelling to be used not to mention prescribed. 5, 6

“We are very proud to see another product rapidly moving for you to the market, which marks yet an additional important inflection point and also milestone within Novaliq’s growth trajectory”, said Dr . Mathias Hothum, board member as well as managing director of dievini. “We are currently evaluating the commercialization strategies which includes talking to help interested parties. ”

About CyclASol® 
CyclASol® is really a first-of-a-kind topical therapy of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol® excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue.   The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits intended for patients, such as improved tolerability and decreased visual disturbances.

The NDA is supported by safety plus efficacy results in over 1, 000 patients with DED from some sort of Phase 2 dose finding study, this Phase 2b /3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study in addition to its open label extension study. 7, 8

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

Effects about the ocular surface   include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring CyclASol® in both studies at Days 15 together with 29. Up to 71. 6% with patients   responded within four weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion for responders was significantly higher compared to vehicle-treated patients inside both research. Responders showed also statistically significant enhancements in a good variety about symptoms compared to non-responders at day 29. The ASCRS recommendations recognize corneal staining as the single most important medical sign in DED as it indicates the level of epithelial harm and visual impairment, and if left undertreated, DED can become chronic and more difficult in order to treat. 3

Effect on tear production : In both studies, in comparison to vehicle at your end from treatment, there was your statistically substantial (p< 0. 05) increased percentage of patients  having increases associated with ≥  10 mm through baseline throughout Schirmer’s tear test score at Day 85 and additionally Day 29, respectively, confirming a known effect regarding the active ingredient cyclosporine. Meeting this endpoint around two impartial studies will be clinically important on its own not to mention considered to be able to demonstrate efficacy for that remedy of signs and symptoms of DED.

H ead-to-head data   versus Restasis™  from the exact phase 2 study suggest that CyclASol® has some stronger and also faster therapeutic effect on the ocular exterior. eight

Maintenance of impact   results from the particular long-term research CYS-005 confirmed that the effect of CyclASol® was managed, and even improved to get most endpoints, over typically the 52-week treatment method period.

Safety as well as Tolerability : Tolerability involving CyclASol® was shown by high drop comfort patient ratings inside of both studies. The most common adverse reaction observed was instillation site reactions, which has been reported on 8. 1% of individuals within the pooled studies. These were in all but one case mild. The only other undesirable reaction reported in > 2% connected with the patients was visible acuity reduced (2. 7%).

About Novaliq
Novaliq is a fabulous biopharmaceutical company focusing on this development and commercialization with first- plus best-in-class visor therapeutics based on EyeSol®, often the worldwide first water-free technology.

EyeSol® is usually Novaliq’s proprietary water-free technologies using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert by using excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today’s unmet healthcare needs for millions about patients through eye diseases.

In July 2022 submitting of a New Drug Software (NDA) for you to the Circumstance. S. Food and Drug Administration (FDA) has been announced seeking approval pertaining to NOV03 (perfluorohexyloctane), for your proposed indicator of treating the signs and symptoms of dry eye condition (DED) associated with Meibomian gland dysfunction (MGD). In addition to CyclASol®, the company continues to progress multiple additional pipeline opportunities depending on the validated EyeSol® platform, each in ophthalmology and adjacent indications like dermatology.

Novaliq GmbH is definitely headquartered during Heidelberg , Germany in addition to Novaliq Inc. has an office at Cambridge, MOTHER , USA. The long-term shareholder can be dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and even Health Sciences companies. More on www.novaliq.com .

Recommended Readings

  1. Leonardi A, Modugno RL, & Salami E. Allergy and Dry Eye Disease. Ocular immunology together with inflammation. 2021; 29: 1168–1176

  2. 2020 Dry eyes Products Market Report: A global Analysis meant for 2019 to help 2025. Marketplace Scope

  3. Starr CE, Gupta PK, Farid M, Beckman KA, Chan CC, Yeu E, Gomes JAP, Ayers BD, Berdahl JP, Holland EJ, Kim T, Mah FS (the ASCRS Cornea Clinical Committee). An algorithm for your preoperative diagnosis and additionally remedying of ocular surface disorders. J Cataract Refract Surg. 2019; 45: 669–684

  4. Donaldson K, Parkhurst G, Saenz B, Whitley W, Williamson B, Hovanesian J. Call to action: treating dry eye disorder and setting the foundation for successful surgery. J Cataract Refract Surg. 2022; 48: 623–629

  5. White DE, Zhao Y, Ogundele The, Fulcher N, Acs A new, Moore-Schiltz L, Karpecki PM. Real-World Therapy Patterns Of Cyclosporine Ophthalmic Emulsion And Lifitegrast Ophthalmic Solution Among Patients With Dry Eye. Clin Ophthalmol. 2019; 13: 2285-2292

  6. Dunn JD, Karpecki EVENING, Meske ME, Reissman D. Evolving knowledge of the exact unmet needs in dry eyes disease. Am J Manag Care. 2021; 27: S23-32

  7. Sheppard JD, Wirta DL, McLaurin E, Boehmer BE, Ciolino CB, Meides AS, Schlüter T, Ousler GW, Usner Deb,   Krösser S. Some sort of Water-free 0. 1% Cyclosporine A Solution for Treatment in Dry eyes Disease: Results of the Randomized Phase II/III ESSENCE Study. Cornea. 2021; 40: 1290-1297

  8. Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch G, Beckert M, Ousler GM, Steven P, Krösser S. A good Clinical Stage II Study to Assess Efficacy, Safety, not to mention Tolerability from Waterfree Cyclosporine Formulation designed for Treatment of Dry Vision Disease. Ophthalmology. 2019; 126: 793-800

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Novaliq Media Contact:
Simone Angstmann-Mehr
[email protected] com
+49 6221 50259-0

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