Latanoprost

DEDHAM, Mass.--( BUSINESS WIRE )-- Qlaris Bio, Inc. , a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced positive topline results from two U.S. Phase II clinical trials investigating QLS-111 in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). The Phase II trials (Osprey and Apteryx) successfully met all primary and secondary endpoints. Qlaris Bio will present a corporate update at the Glaucoma 360 New Horizons Forum 2025 on February 7 th in San Francisco, CA. The Osprey study ( NCT06016972 ), is a masked, randomized trial assessing the safety, tolerability, and intraocular pressure (IOP)-lowering activity of QLS‑111 across a range of doses compared to vehicle in 62 adult patients with POAG or OHT. The study demonstrated that the 0.015% concentration of QLS-111 dosed QPM (once daily in the evening) drove the greatest decrease in IOP, highlighted by mean reductions of 3.7 mmHg from mean diurnal baseline IOP of 23.0 mmHg. The Apteryx study ( NCT06249152 ) is a masked, randomized trial assessing the safety, tolerability, and additive IOP-lowering efficacy of QLS‑111 dosed in addition to latanoprost compared to latanoprost alone in 32 patients aged 12 years or older with POAG or OHT who were stable on latanoprost monotherapy. Patients’ mean diurnal baseline IOP with latanoprost monotherapy was 19.8 mmHg. QLS-111 0.015% dosed with latanoprost drove additive mean IOP reductions as compared to latanoprost monotherapy, achieving a 3.2 mmHg greater reduction for QLS-111 QPM dosing and 3.6 mmHg greater reduction for QLS-111 BID (twice daily) dosing. Importantly, all QLS-111 concentrations and dose regimens across both studies demonstrated excellent safety and tolerability. No serious adverse events were reported, nor did investigators observe any clinically meaningful hyperemia or other ocular or systemic adverse events. In addition, no incremental hyperemia was observed when QLS-111 0.015% was added to latanoprost. “We are pleased with QLS-111’s performance in our Phase II Osprey and Apteryx trials,” said Thurein Htoo, Chief Executive Officer, Qlaris Bio. “These results with our novel preservative-free formulation give us confidence that the selective targeting of episcleral venous pressure (EVP) with QLS-111 has the potential to be a first-in-class therapeutic.” “The data show QLS-111’s synergistic ability to provide significant IOP lowering in patients already on latanoprost,” said Barbara Wirostko, MD, FARVO, Chief Medical Officer, Qlaris Bio. “This substantial additive effect demonstrates the potential to significantly benefit patients who do not achieve IOP lowering goals with current therapies. Additionally, we believe the promising tolerability profile of QLS-111 will further enhance the value to our patients by driving improved treatment compliance and adherence. This is supported by the absence of clinically relevant hyperemia, with no corneal changes and no clinically relevant ocular or systemic findings thus far in our studies.” “The QLS-111 Phase II data are quite promising and indicative of an innovative therapy,” said Professor Ike Ahmed, MD, FRCSC, Director of the Alan S. Crandall Center for Glaucoma Innovation at the Moran Eye Center, University of Utah. “Along with its attractive safety profile, the potential of QLS-111 to surpass the additive efficacy of other glaucoma medications when used with latanoprost, means patients can remain on a drug that can achieve better IOP control. The robust results of the Osprey and Apteryx trials give me confidence that our patients may soon have an important new treatment option that targets this clear unmet need. Furthermore, the possibility of combining QLS-111 with trabecular meshwork MIGS procedures to address downstream resistance may unlock the potential of these procedures.” About QLS‑111 QLS‑111 is a novel topical formulation using Qlaris Bio’s ATP-sensitive potassium channel modulator platform originally developed by Michael Fautsch, Ph.D., professor of ophthalmology, biochemistry, and molecular biology at the Mayo Clinic in Rochester, Minnesota. QLS-111 lowers IOP by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP. Though multiple mechanisms of action exist to lower IOP in patients with glaucoma, these agents target only three of the four components of IOP as described by the Goldmann equation for IOP: the aqueous humor inflow rate, the uveoscleral outflow rate, and the conventional outflow facility. There are currently no approved drugs that primarily target the reduction of EVP. This leaves a significant gap in the potential to maximally lower IOP, since EVP can be the largest determinant of overall IOP. About Qlaris Bio, Inc. Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, who co-led the company’s $24 million Series B funding round in April 2024. Other investors include Correlation Ventures, Mayo Clinic, and funds managed by abrdn Inc. For more information, please visit www.qlaris.bio .

Press Release Nicox Announces Scientific Presentation and Conference Attendance in H1 2025January 28, 2025 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced a presentation at the upcoming American Glaucoma Society (AGS) Annual Meeting 2025 and participation in a number of key ophthalmology and financial conferences in the first half of 2025. Presentation of additional analysis of the NCX 470 Mont Blanc Phase 3 Clinical trial AGS 2025 Annual Meeting – February 26 to March 2, 2025, Washington, U.S. Poster Title: Diurnal Intraocular Pressure Control Responder Analysis with NCX 470 Versus Latanoprost in the Phase 3 MONT BLANC TrialType: Poster Presentation Session Date: Saturday March 1, 2025 from 7:00 am to 8:00 am (local time). Presenter: Dr. Robert Fechtner, Chair of the Department of Ophthalmology at SUNY Upstate Medical University in Syracuse, NY Upcoming Conference Attendance Allinvest securities Biomed Forum – February 4, 2025 – Paris, France Investor Access – April 1-2, 2025 – Paris, France Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting – May 4-8, 2025 – Salt Lake City, Utah, U.S.BIO International Convention – June 16-19, 2025 – Boston, MA, U.S. Members of the management team will be available for one-on-one meetings at these events. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.com Analyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2023” and in section 4 of the “Rapport semestriel financier et d’activité 2024” which are available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_H1_2025_CONFERENCES_PR_FINAL