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
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.
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.
Inc. Barry Butler
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HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).