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.
Table of Contents
OVERVIEW
KEY TAKEAWAYS
DISEASE BACKGROUND
- Definition
- Patient segmentation
- Symptoms
- Risk factors
- Diagnosis
TREATMENT
- Ocular lubricants
- Prescription drugs
- Eyelid hygiene
- Surgical treatment
EPIDEMIOLOGY
MARKETED DRUGS
PIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
- NovaTears for Dry Eye (April 13, 2021)
- RGN-259 for Dry Eye (March 18, 2021)
- Visomitin for Dry Eye (February 22, 2021)
- Reproxalap for Dry Eye (January 7, 2021)
- NovaTears for Dry Eye (December 22, 2020)
- PL-9643 for Dry Eye (December 15, 2020)
- Voclosporin Ophthalmic Solution (VOS) for Dry Eye (November 2, 2020)
- OC-01 Nasal Spray for Dry Eye (May 11, 2020)
- EYSUVIS for Dry Eye (March 9, 2020)
- Reproxalap for Dry Eye (December 3, 2019)
- OC-01 Nasal Spray for Dry Eye (October 4, 2019)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Oyster Point Pharma Submits NDA For OC-01 Nasal Spray
- FDA Approves Eysuvis For Dry Eye Disease
- EMA Unconvinced By Xiidra Dry Eye Data
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- IACTA Licenses Dry Eye, Conjunctivitis Candidates To Zhaoke
REVENUE OPPORTUNITY
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
BIBLIOGRAPHY
APPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of dry eye disease, 2020–29
Figure 2: Overview of pipeline drugs for dry eye disease in the US
Figure 3: Pipeline drugs for dry eye disease, by company
Figure 4: Pipeline drugs for dry eye disease, by drug type
Figure 5: Pipeline drugs for dry eye disease, by classification
Figure 6: NovaTears for Dry Eye (April 13, 2021): Phase III - GOBI
Figure 7: RGN-259 for Dry Eye (March 18, 2021): Phase III - ARISE-3 (US)
Figure 8: Visomitin for Dry Eye (February 22, 2021): Phase III - VISTA-2
Figure 9: Reproxalap for Dry Eye (January 7, 2021): Phase III - TRANQUILITY
Figure 10: NovaTears for Dry Eye (December 22, 2020): Phase II - SEECASE
Figure 11: PL-9643 for Dry Eye (December 15, 2020): Phase II - PL9643-201
Figure 12: Voclosporin Ophthalmic Solution (VOS) for Dry Eye (November 2, 2020): Phase II/III - AUDREY
Figure 13: OC-01 Nasal Spray for Dry Eye (May 11, 2020): Phase III - ONSET-2
Figure 14: EYSUVIS for Dry Eye (March 9, 2020): Phase III - STRIDE 3
Figure 15: Reproxalap for Dry Eye (December 3, 2019): Phase III - RENEW
Figure 16: OC-01 Nasal Spray for Dry Eye (October 4, 2019): Phase IIb - ONSET-1
Figure 17: Key upcoming events in dry eye disease
Figure 18: Probability of success in the ophthalmology-other pipeline
Figure 19: Clinical trials in dry eye disease
Figure 20: Top 10 drugs for clinical trials in dry eye disease
Figure 21: Top 10 companies for clinical trials in dry eye disease
Figure 22: Trial locations in dry eye disease
Figure 23: Dry eye disease trials status
Figure 24: Dry eye disease trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of dry eye disease, 2020–29
Table 2: Marketed Drugs for dry eye disease
Table 3: Pipeline drugs for dry eye disease in the US
Table 4: NovaTears for Dry Eye (April 13, 2021)
Table 5: RGN-259 for Dry Eye (March 18, 2021)
Table 6: Visomitin for Dry Eye (February 22, 2021)
Table 7: Reproxalap for Dry Eye (January 7, 2021)
Table 8: NovaTears for Dry Eye (December 22, 2020)
Table 9: PL-9643 for Dry Eye (December 15, 2020)
Table 10: Voclosporin Ophthalmic Solution (VOS) for Dry Eye (November 2, 2020)
Table 11: OC-01 Nasal Spray for Dry Eye (May 11, 2020)
Table 12: EYSUVIS for Dry Eye (March 9, 2020)
Table 13: Reproxalap for Dry Eye (December 3, 2019)
Table 14: OC-01 Nasal Spray for Dry Eye (October 4, 2019)
Table 15: Historical global sales, by drug ($m), 2016–20
Table 16: Forecasted global sales, by drug ($m), 2021–25
Companies Mentioned
- Oyster Point Pharma
