KALA BIO (KALA) FY Conference Transcript

Summary of KALA BIO (KALA) FY Conference - August 13, 2025 Industry Overview - The conference focused on novel drugs for front of the eye indications, particularly in ophthalmology, featuring multiple panelists from various companies including KALA Bio, HARO, OkioPharma, and Cularis Bio [1][2][3] Key Points and Arguments Unmet Needs in Ophthalmology - Dry eye disease is a significant issue, especially in low humidity areas like West Texas, where patients frequently seek treatment [6][7] - There are various conditions affecting the front of the eye, including corneal diseases, glaucoma, and cataracts, indicating a broad spectrum of unmet medical needs [6][7] Emerging Treatments - The evaluation of emerging treatments is based on their ability to improve patient outcomes and ease of use [8][9] - Barriers to integrating novel treatments include the need for development, regulatory challenges, and ensuring patient compliance [10][11] KALA Bio's Innovations - KALA Bio's KPI 12 utilizes a mesenchymal stem cell secretome to promote corneal healing, addressing multiple biological pathways involved in impaired healing [22][25] - The product aims to provide essential biomolecules that stimulate healing across various pathways, which is crucial for patients with persistent corneal epithelial defects (PCED) [27][28] Commercial Performance and Strategy - KALA Bio reported a 66% growth in total prescriptions quarter-over-quarter, with a significant portion being new prescriptions, attributed to their unique access program [19][20] - The company aims to capture a larger share of the cyclosporine market, currently ranking second in the U.S. [20] Competitive Landscape - KALA Bio's VeeVi is the first water-free cyclosporine product, delivering significantly higher concentrations to the cornea compared to traditional therapies, which often cause discomfort [16][17] - The product has shown rapid onset of action and sustained benefits, making it a strong competitor in the dry eye market [18][19] Clinical Trials and Expectations - KALA Bio is anticipating results from the phase two CHACE trial, with previous trials showing promising healing rates in patients with PCED [28][29] - The company is focused on demonstrating efficacy and safety to facilitate regulatory approval and market adoption [30][31] Neuropathic Corneal Pain Treatment - OkioPharma's ircosimod targets neuropathic corneal pain, a condition with no FDA-approved treatments, showing significant pain reduction in trials [31][36] - The drug is positioned as a potential first-line treatment for patients who have failed other therapies, including opioids [36][37] Glaucoma Treatment Innovations - Cularis Bio's QLS 111 targets episcleral venous pressure, a previously unaddressed component of intraocular pressure (IOP), offering a new approach for glaucoma management [45][46] - The product is expected to be complementary to existing therapies, particularly for patients with normal tension glaucoma, which is prevalent in Asian populations [48][49] Barriers to Adoption - Key barriers to the adoption of new therapies include physician hesitance, regulatory hurdles, and payer reimbursement challenges [64][66] - Physicians often require time to gain experience with new treatments before widespread adoption occurs [66][67] Future Directions - KALA Bio and its competitors are focused on advancing their clinical trials and addressing the regulatory landscape to bring innovative treatments to market [70][74] - The emphasis is on demonstrating consistent efficacy across diverse patient populations to secure FDA approval and enhance market penetration [71][74] Additional Important Content - The discussion highlighted the importance of addressing both the inflammatory and evaporative components of dry eye disease through innovative drug delivery systems [56][57] - The potential for combination therapies was noted, particularly in enhancing patient compliance and treatment outcomes [50][51] This summary encapsulates the key discussions and insights from the KALA Bio conference, emphasizing the ongoing innovations and challenges within the ophthalmology sector.