Market Spotlight: Dry Eye Disease

This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• The publisher estimates that in 2020, there were 1.52 billion prevalent cases of dry eye worldwide, and forecasts that number to increase to 1.72 billion prevalent cases by 2029.
• The approved drugs in the dry eye space focus on a wide variety of targets. The majority of approved drugs are administered via the topical route, with one product available as an intraocular/subretinal/subconjunctival formulation.
• The majority of industry-sponsored drugs in active clinical development for dry eye are in Phase II, with only one drug in the NDA/BLA phase.
• Therapies in development for dry eye focus on a wide variety of targets. The majority of pipeline drugs are administered via the topical route, with the remainder being intranasal, oral, and intraocular/subretinal/subconjunctival formulations.
• High-impact upcoming events for drugs in the dry eye space comprise topline Phase II trial results for NRO-1, ECF843, and OTXCSI; topline Phase IIb trial results for AR-15512; topline Phase III trial results for MIM-D3 and CyclASol; and an expected PDUFA date for OC-01 Nasal Spray.
• The overall likelihood of approval of a Phase I ophthalmology-other asset is 22.8%, and the average probability a drug advances from Phase III is 55%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 8.9 years in the overall ophthalmology space.
• The distribution of clinical trials across Phase I-IV indicates that the majority of trials for dry eye have been in the late phases of development, with 56% of trials in Phase III-IV, and only 44% in Phase I-II.
• The US has a substantial lead in the number of dry eye clinical trials globally. France leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the dry eye space is dominated by completed trials. Novartis has the highest number of completed clinical trials for dry eye, with 87 trials.
• Novartis leads industry sponsors with the highest overall number of clinical trials for dry eye, followed by AbbVie.