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Betaliq Initiates Enrollment of Phase 2 Clinical Trial For The Treatment of Glaucoma or Ocular Hypertension

Betaliq Initiates Enrollment of Phase 2 Clinical Trial Investigating BTQ-1901-A, BTQ 1901 B and BTQ-1902 For The Treatment of Glaucoma or Ocular Hypertension

TAMPA, FL, UNITED STATES, April 20,2021 /EINPresswire.com/ — Betaliq, Inc., a clinical-stage ophthalmic company focused on developing therapies for the treatment of glaucoma, today announced enrollment of the first subject in their Phase 2 clinical trial. Betaliq’s pipeline consists of two preservative-free and water-free glaucoma drug candidates based on Novaliq GmbH’s EyeSol® technology. EyeSol is the worldwide first and only water-free technology for topical ophthalmology products. Two EyeSol based ophthalmic products are currently approved in Europe and Australia and two active INDs are in late-stage development in the United States.

This Phase 2 multicenter, double-masked, 12-week, parallel-group, dose-ranging study aims to evaluate the ocular and systemic safety and the efficacy of BTQ-1901 (0.5% [A] and 1% [B] concentrations) and BTQ 1902 ophthalmic suspensions compared to 0.5% timolol ophthalmic solution in adult patients with elevated intraocular pressure (IOP) due to primary open-angle glaucoma or ocular hypertension. The study is expected to randomize 240 subjects in clinical sites across the US. The primary analysis will compare IOP values at three time points after 2 weeks, 6 weeks and 12 weeks of treatment.

Barry Butler, President and CEO of Betaliq commented, “We are very excited to advance our products into the clinic. BTQ-1901 and BTQ-1902 are based on Novaliq’s EyeSol technology that offers important advantages over traditional eye drop technology, including a drop size approximately 25% of the size of water-based drops. This smaller drop size has the potential to result in less systemic absorption and fewer negative systemic side effects that can be caused by beta blockers. Other advantages of EyeSol include longer residence time on the eye, better penetration into the ocular tissues, and no need for toxic preservatives. I believe the advantages offered by the EyeSol platform will bring significant benefits to glaucoma patients.”

Glaucoma is the leading cause of irreversible blindness worldwide, with an estimated 80 million people currently affected by the condition. The US glaucoma market of more than 3.0 million diagnosed patients is expected to expand further due to an aging population1. Ophthalmic beta blockers are a sizeable and growing therapeutic option in this market. Source: (1) Bright Focus Foundation, https://www.brightfocus.org/glaucoma/article/glaucoma-facts-figures

ABOUT BETALIQ
Betaliq, Inc. is a collaboration between Novaliq, and BLP Management Group, LLC. Betaliq was formed to develop ophthalmic beta blockers using Novaliq’s patented EyeSol non water formulation technology.

EyeSol is the first and only water-free eye drop technology for ophthalmology products. The EyeSol technology offers important advantages over traditional eye drops, including a drop size approximately 1/4 of the size of water-based drops. This smaller drop size has the potential to result in less systemic absorption. Other advantages of EyeSol® include longer residence time on the eye, better penetration, and no need for toxic preservatives.
Betaliq is developing two beta blockers for the treatment of glaucoma. BTQ-1901 is an EyeSol based drug product of a potent selective beta blocker that has not previously been used to treat glaucoma. BTQ-1902 is an EyeSol-based drug product of timolol, the most commonly prescribed beta blocker.
Beta blockers are one of the most commonly prescribed classes of medicines to treat glaucoma. Beta blockers reduce IOP by blockade of sympathetic nerve endings in the ciliary epithelium causing a fall in aqueous humor production. Beta blockers are often prescribed in combination with other glaucoma medications. Betaliq, Inc. is incorporated in Delaware and based in Tampa, Florida. More on www.betaliq.com.

ABOUT NOVALIQ
Novaliq is a pharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. Novaliq is headquartered in Heidelberg, Germany and 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.

Betaliq,
Inc. Barry Butler
+1 813-766-9539
email us here

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Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA).

Novaliq Receives Positive CHMP Opinion FOR Vevizye® in Dry EYE Disease

Heidelberg, Germany, and Cambridge, MA, USA, July 29, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye®, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (Ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, August 24, 2023 – Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).

Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE® (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq

VEVYE® is the First and Only Cyclosporine-Based Product Indicated for the Treatment of Both Signs and Symptoms of Dry Eye Disease with Efficacy Demonstrated After Four Weeks VEVYE® is the Only Water-Free Ophthalmic Product with Convenient Twice-Daily (BID) Dosing NASHVILLE, Tenn. & HEIDELBERG, Germany, July 18, 2023 – Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Novaliq GmbH, a German biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non-preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol® water-free technology. VEVYE, which is dispensed topically in a unique 10 microliter per one drop and is labeled for twicedaily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023, by the U.S. Food and Drug Administration (FDA).

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan

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