PR97356

HEIDELBERG, Germany, and CAMBRIDGE, MA, August 9, 2022, /PRNewswire=KYODO JBN/--

Novaliq, a biopharmaceutical company focusing on first- and best-in-class

ocular therapeutics based on the unique EyeSol(R) water-free technology, today

announced the submission of a New Drug Application (NDA) to the U.S. Food and

Drug Administration (FDA) seeking approval for CyclASol(R) (cyclosporine

ophthalmic solution), a proposed novel treatment for the signs and symptoms of

dry eye disease(DED).

CyclASol(R) 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 and

symptom endpoints.

“This is the first submission of a novel product category of water-free topical

drug therapies utilizing EyeSol(R) as a drug carrier”, said Christian Roesky,

Ph.D., CEO, Novaliq. “CyclASol(R) is a first-of-a-kind drug therapy and aims to

expand treatment success for patients with dry eye disease and their eye care

professionals. If approved by the FDA, CyclASol(R) 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, with approximately

18 million Americans diagnosed with DED.1,2 Inflammation and immunologic

processes play a key role in the pathology of the disease.

A compromised ocular surface secondary 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

of the corneal surface damage secondary to DED on 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 for better tolerated drugs with an early onset of therapeutic effect,

which are compelling to be used and prescribed.5,6

“We are very proud to see another product rapidly moving to the market, which

marks yet another important 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(R)

CyclASol(R) is a first-of-a-kind topical treatment of cyclosporine, a potent

anti-inflammatory and selective immunomodulatory drug. Whilst not

water-soluble, cyclosporine is soluble in the EyeSol(R) 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 for patients, such as improved tolerability and decreased

visual disturbances.

The NDA is supported by safety and efficacy results in over 1,000 patients with

DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the

Phase 3 ESSENCE-2 study and its open label extension study.7,8

CyclASol(R) 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 in

total corneal fluorescein staining (tCFS) score favoring CyclASol(R) in both

studies at Days 15 and 29. Up to 71.6% of patients  responded within four weeks

with a clinically meaningful improvement of (greater than or equal to) 3 grades

in total corneal staining. This proportion of responders was significantly

higher compared to vehicle-treated patients in both studies. Responders showed

also statistically significant improvements in a variety of symptoms compared

to non-responders at day 29. The ASCRS guidelines recognize corneal staining as

the single most important clinical sign of DED as it indicates the level of

epithelial damage and visual impairment, and if left undertreated, DED can

become chronic and more difficult to treat.3

Effect on tear production: In both studies, compared to vehicle at the end of

treatment, there was a statistically significant (p<0.05) higher percentage of

patients with increases of (greater than or equal to) 10 mm from baseline in

Schirmer’s tear test score at Day 85 and Day 29, respectively, confirming a

known effect of the active ingredient cyclosporine. Meeting this endpoint in

two independent studies is clinically meaningful on its own and considered to

demonstrate efficacy for the treatment of signs and symptoms of DED.

Head-to-head data versus Restasis(TM) from the phase 2 study suggest that

CyclASol(R) has a stronger and faster therapeutic effect on the ocular surface.8

Maintenance of effect results from the long-term study CYS-005 confirmed that

the effect of CyclASol(R) was maintained, and even improved for most endpoints,

over the 52-week treatment period.

Safety and Tolerability: Tolerability of CyclASol(R) was shown by high drop

comfort patient ratings in both studies. 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 in > 2% of the patients was visual acuity

reduced (2.7%).

About Novaliq

Novaliq is a biopharmaceutical company focusing on the development and

commercialization of first- and best-in-class ocular therapeutics based on

EyeSol(R), the worldwide first water-free technology. EyeSol(R) is Novaliq’s

proprietary water-free technology using ultrapure semifluorinated alkanes

(SFAs) that are physically, chemically, and physiologically inert with

excellent biocompatibility and a very good safety profile. Novaliq offers an

industry-leading portfolio addressing today’s unmet medical needs of millions

of patients with eye diseases.

In July 2022 submission of a New Drug Application (NDA) to the U.S. Food and

Drug Administration (FDA) was announced seeking approval for NOV03

(perfluorohexyloctane), for the proposed indication of treating the signs and

symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction

(MGD). In addition to CyclASol(R), the company continues to progress multiple

additional pipeline opportunities based on its validated EyeSol(R) platform,

both in ophthalmology and adjacent indications like dermatology.

Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an

office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech

holding GmbH & Co. KG, an active investor in Life and Health Sciences

companies. More on www.novaliq.com .  

Recommended Readings

1. Leonardi A, Modugno RL, & Salami E. Allergy and Dry Eye Disease. Ocular

immunology and inflammation. 2021; 29:1168–1176

2. 2020 Dry Eye Products Market Report: A global Analysis for 2019 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 for the preoperative diagnosis and treatment 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 disease and setting the foundation 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 eye 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 D,  Krosser S. A Water-free 0.1% Cyclosporine A

Solution for Treatment of Dry Eye 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, Krosser S. A Clinical Phase II Study to Assess

Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for

Treatment of Dry Eye Disease. Ophthalmology. 2019; 126:793-800

Any product/brand names and/or logos are trademarks of the respective owners.

(C) 2022 Novaliq GmbH, Heidelberg, Germany.

Novaliq Media Contact:

Simone Angstmann-Mehr

info@novaliq.com

+49 6221 50259-0

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Source: Novaliq GmbH