HEIDELBERG , Germany , and CAMBRIDGE, MA , Aug. 9, 2022 /PRNewswire/ — Novaliq, a biopharmaceutical company focusing on first- plus 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 and symptoms of dry eye disease (DED).

CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign plus 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 the first-of-a-kind medication therapy and aims to expand treatment success for patients with dry vision disease plus their attention care professionals. If approved by the FDA, CyclASol® addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration. ”

Dry eye is one of the most common ocular surface disorders, along with approximately 18 million Americans diagnosed with DED. 1, 2 Inflammation and immunologic processes play a key role within the pathology of the disease.

A compromised ocular surface area secondary in order to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries. 3, 4 The impact from the corneal surface damage secondary to DED on visible function is an underestimated aspect of the illness. Multiple guidelines recommend therapy of the particular corneal surface area damage prior to ocular procedures. A high unmet need remains with regard to better tolerated drugs with an early onset associated with therapeutic effect, which are usually compelling to be used and prescribed. 5, 6

“We are very proud to see another item rapidly moving towards the market, which marks yet another essential inflection point and milestone in Novaliq’s growth trajectory”, said Dr. Mathias Hothum, board member and managing director of dievini. “We are currently evaluating the commercialization strategies which includes talking to interested parties. ”

About CyclASol® 
CyclASol® is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory plus 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 particular product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional medical benefits regarding patients, such as enhanced tolerability plus decreased visual disturbances.

The NDA is supported by safety and efficacy results in over one, 000 patients with DED from the Phase 2 dose finding study, the particular Phase 2b /3 ESSENCE-1 research, the Phase 3 ESSENCE-2 study plus its open label extension study. 7, 8

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

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

Effect on tear production : In both studies, in comparison to vehicle at the end of treatment, there was a statistically significant (p< 0. 05) higher percentage of patients  with increases of ≥  10 mm from baseline in Schirmer’s tear test score at Day 85 and Day 29, respectively, confirming the known effect of the active ingredient cyclosporine. Meeting this endpoint in 2 independent studies is clinically meaningful on its own and considered to demonstrate effectiveness for the remedying of signs and symptoms of DED.

H ead-to-head data   versus Restasis™  from the phase 2 study suggest that CyclASol® has a stronger and faster therapeutic impact on the particular ocular surface. 8

Maintenance associated with effect   results from the long-term research CYS-005 confirmed that the particular a result of CyclASol® was maintained, as well as improved for many endpoints, over the 52-week treatment period.

Safety and Tolerability : Tolerability of CyclASol® was shown by high drop comfort and ease patient ratings both in research. The most common adverse reaction observed was instillation site reactions, which was reported in 8. 1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported within > 2% of the patients was visual acuity reduced (2. 7%).

About Novaliq
Novaliq is a biopharmaceutical company focusing on the development and commercialization associated with first- plus best-in-class ocular therapeutics based on EyeSol®, the particular worldwide first water-free technologies.

EyeSol® will be Novaliq’s proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert along with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today’s unmet healthcare needs of millions associated with patients with eye diseases.

In July 2022 submitting of a New Drug Software (NDA) in order to the Circumstance. S. Food and Drug Administration (FDA) was announced seeking approval intended for NOV03 (perfluorohexyloctane), for the proposed indication of treating the indicators and 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 based on its validated EyeSol® platform, both in ophthalmology and adjacent indications like dermatology.

Novaliq GmbH is headquartered in Heidelberg , Philippines and Novaliq Inc. has an office in Cambridge, MOTHER , USA. The long-term shareholder is usually dievini Hopp BioTech holding GmbH & Co. KG, an active investor inside Life plus Health Sciences companies. More on www.novaliq.com .  

Recommended Readings

  1. Leonardi A, Modugno RL, & Salami E. Allergy and Dry Vision Disease. Ocular immunology plus inflammation. 2021; 29: 1168–1176
  2. 2020 Dried out Eye Products Market Report: A global Analysis to get 2019 in order to 2025. Market 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 pertaining to the preoperative diagnosis and treatment of ocular surface area disorders. J Cataract Refract Surg. 2019; 45: 669–684
  4. Donaldson K, Parkhurst G, Saenz B, Whitley W, Williamson W, Hovanesian M. Call to action: dealing with dry eyesight disease plus setting the particular foundation meant for successful surgery. J Cataract Refract Surg. 2022; 48: 623–629
  5. White DE, Zhao Y, Ogundele A, Fulcher N, Acs A, Moore-Schiltz L, Karpecki PM. Real-World Treatment Patterns Of Cyclosporine Ophthalmic Emulsion And Lifitegrast Ophthalmic Solution Among Patients With Dry Eye. Clin Ophthalmol. 2019; 13: 2285-2292
  6. Dunn JD, Karpecki PM, Meske ME, Reissman D. Evolving knowledge of the unmet needs in dry eyes disease. Am J Manag Care. 2021; 27: S23-32
  7. Sheppard JD, Wirta DL, McLaurin Electronic, Boehmer BE, Ciolino CB, Meides AS, Schlüter T, Ousler GW, Usner D,   Krösser S. A Water-free 0. 1% Cyclosporine A Answer for Therapy of Dry out Eye Disease: Results associated with the Randomized Phase II/III ESSENCE Study. Cornea. 2021; 40: 1290-1297
  8. Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch Gary the gadget guy, Beckert M, Ousler GM, Steven P, Krösser S. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation designed for Treatment of Dry Eye Illness. Ophthalmology. 2019; 126: 793-800

Any product/brand names and/or logos are usually trademarks associated with the respective owners.   © 2022 Novaliq GmbH, Heidelberg , Australia .

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

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SOURCE Novaliq GmbH

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