Bimatoprost

SpyGlass prepares for End of Phase II meeting with the FDA to advance its Drug Delivery Platform into Phase III pivotal studiesInnovative platform has the potential to enable all cataract surgeons to treat glaucoma during routine cataract procedures ALISO VIEJO, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, today announced completion of enrollment in its Phase I/II, randomized, multi-center, controlled clinical trial (NCT06120842) evaluating SpyGlass’ Drug Delivery Platform in patients with glaucoma or ocular hypertension. The SpyGlass platform is designed to deliver multiple years of bimatoprost to lower intraocular pressure (IOP) and is implanted during routine cataract surgery. “Chronic eye conditions, such as glaucoma, can lead to vision loss and significantly impact quality of life. That’s why SpyGlass is singularly focused on making a difference for those in need,” said Patrick Mooney, SpyGlass Pharma’s Chief Executive Officer. “Completing enrollment in this study is an important milestone in our efforts to bring the SpyGlass technology to millions of patients around the world. We look forward to continued engagement with the FDA as we advance our platform toward two large Phase III trials.” “The SpyGlass technology continues to demonstrate great potential for improving care in glaucoma patients undergoing routine cataract surgery,” said Malik Kahook, M.D., co-founder of SpyGlass Pharma™. “As the SpyGlass platform is implanted using standard surgical techniques, it could significantly expand the integration of glaucoma treatment into routine cataract procedures. This could enhance adoption across a broad spectrum of surgeons and practices, setting our platform apart from currently available glaucoma interventions.” Dr. Kahook added, “We are deeply grateful to the investigators and patients whose participation has been essential to advancing this clinical trial. Their trust and commitment have helped bring us closer to delivering a treatment that could significantly enhance care for glaucoma patients worldwide.” ABOUT SPYGLASS PHARMA The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. SpyGlass will continue to release data from both the first-in-human study, which was recently published with 18-month data, and this Phase I/II study as it becomes available. SpyGlass looks forward to working closely with the U.S. Food and Drug Administration (FDA) to advance the program to commercial approval. SpyGlass Pharma was co-founded by Dr. Malik Y. Kahook, M.D. and Glenn Sussman. The company is focused on the development of the world’s first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. SpyGlass is backed by investors including New Enterprise Associates (NEA), RA Capital, Vensana Capital, Samsara BioCapital and Vertex Ventures HC. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding. http://www.spyglasspharma.com Media Contact:Angela Salerno-Robin 312-545-9331asalerno-robin@dna-comms.com

Press Release Nicox Announces Publication of the Adaptive Design Period of the NCX 470 Mont Blanc Phase 3 Trial An adaptive design is a useful clinical trial design tool which allowed identification of the optimal dose of NCX 470 in the Mont Blanc trial, the first Phase 3 trial of NCX 470Both doses of NCX 470 ophthalmic solution tested, 0.065% and 0.1%, lowered intraocular pressure more than the comparator, latanoprost 0.005% ophthalmic solutionThe 0.1% NCX 470 concentration was chosen for the remainder of the Mont Blanc trial and the ongoing Denali trial based on a greater intraocular pressure reduction compared to the 0.065% concentration and a good safety profile November 18, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the design details and results of the adaptive design period of the NCX 470 Mont Blanc Phase 3 trial evaluating the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension have been published online in Contemporary Clinical Trials, Volume 147, 2024, 107730 (online pre-publication https://doi.org/10.1016/j.cct.2024.107730). A portion of this data has previously been presented as a poster at the 2023 World Glaucoma Congress. The dose finding Phase 2 trial (Dolomites) tested NCX 470 at several concentrations and the results suggested that a higher dose than those tested might provide even better efficacy and safety profile. To test this, concentrations of 0.065% and 0.1% were included in an adaptive dose selection period of the Phase 3 Mont Blanc trial, which compared the safety and efficacy of NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution in adult subjects with open-angle glaucoma or ocular hypertension. At the Week 2 timepoint, the least-squares mean difference in diurnal intraocular pressure (IOP) compared to latanoprost were 1.51 mmHg for NCX 470 0.065 % group (p = 0.0308) and 1.71 mmHg for NCX 470 0.1 % group (p = 0.0123), in favor of NCX 470. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (p > 0.05).The adaptive dose selection period was used in place of additional dose ranging studies to select the 0.1% concentration of NCX 470 for the completion of the Mont Blanc clinical trial as well as the second Phase 3 trial, Denali.The results of the Mont Blanc trial were announced in October 2022. The second Phase 3 trial of NCX 470, Denali, is ongoing and topline results are expected in the third quarter of 2025.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.comAnalyst 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.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_MontBlancAdaptiveDesignPublication_PR_FINAL