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.

Summary of Harrow (HROW) FY Conference - August 13, 2025 Company Overview - **Company**: Harrow (HROW) - **Industry**: Ophthalmology and Biopharmaceuticals Key Points and Arguments Acquisition and Product Development - Harrow acquired commercial rights to biosimilar drugs referencing Lucentis and Eylea from Sensome Bioethics, indicating a strategic focus on the retina market [3][4] - The company plans to launch these biosimilars in mid-2026, with expectations of significant clinical synergy with their existing anesthetic product, iHizo [6][7] - Harrow also acquired US commercial rights to Biclovy, a novel steroid for postoperative inflammation, which is differentiated by its robust clinical efficacy and safety profile [21][22][24] Market Position and Competitive Landscape - The biosimilar market for Lucentis and Eylea is competitive, with several existing products; however, Harrow's approach is described as bespoke and customer-oriented, leveraging existing relationships with retina clinics [9][10] - Harrow aims to capture market share in the wet AMD and DME markets, targeting both low-cost options and branded products, with each percentage point of market share representing over $80 million in revenue opportunity [12][13] Financial Outlook and Revenue Growth - The company does not anticipate significant revenue contributions from the new biosimilars in 2026 but expects more substantial contributions in 2027 and 2028 [15] - iHizo reported $18.3 million in revenue for Q2, showing a 25% sequential growth, with strong demand in the retina market [30][31] - The existing product portfolio, including Veevae, is experiencing rapid growth, with a current market share of 7.8% in the US dry eye market, aiming to become the number one prescribed cyclosporine [25][26][28] Regulatory and Market Access - The reimbursement landscape for biosimilars is favorable, with established product-specific Q codes for reimbursement [14] - Harrow emphasizes the importance of coverage, reporting low rejection rates for claims related to iHizo and Triassence, which enhances market access [36][38] Future Prospects and Strategic Goals - Harrow is focused on maintaining a stable presence in the market while exploring additional acquisitions to enhance its product portfolio [50][52] - The company is optimistic about the upcoming launch of MELT 300, expected in 2027, which targets sublingual sedation for cataract surgery [44][47] - Upcoming catalysts include the launch of BioViz and continued growth of existing products, with an investor and analyst day scheduled for September 26, 2025, to discuss these developments [56][57] Additional Important Content - The company is committed to patient-first initiatives, welcoming any new products that can benefit patients in the competitive anti-VEGF market [17][18][20] - Harrow's in-premise Rx business is described as stable and cash-generating, with plans to transition more products to FDA-approved status [39][41][43]