Aldeyra could face an uphill battle in securing a strong position in the dry eye market, says GlobalData
Aldeyra Therapeutics, a small biotech company with no marketed drugs, is aiming to directly compete with Shire and Allergan in the dry eye syndrome market, a lucrative segment estimated to be worth $2.4bn in 2017 in the eight major markets (8MM*), according to GlobalData, a leading data and analytics company.
Aldeyra has recently reported positive Phase IIb data for its leading pipeline drug reproxalap, a small molecule reactive aldehyde species (RASP) sequestering agent for the treatment of dry eye. Within the dry eye market, reproxalap has solid advantages that will distinguish it from the currently marketed drugs—in the US, Allergan’s Restasis (cyclosporine 0.05%) and Shire’s Xiidra (lifitegrast) are the only approved brands for dry eye syndrome and are well-established blockbusters.
In comparison, reproxalap is a first-in-class therapy with a novel mechanism of action, with no significant side effects, and a rapid onset of action. Restasis can take up to six months to show its effects and both Restasis and Xiidra can cause a stinging sensation in the eye.
Maura Musciacco, MSc, Neurology & Ophthalmology Director at GlobalData, comments: “Reproxalap’s positive Phase IIb data certainly are welcome news for dry eye patients and immediately boosted Aldeyra’s shares. However, Aldeyra may still face an uphill battle in trying to secure a strong position in the dry eye market. Reproxalap’s frequency of administration could be the main barrier to uptake, considering it is administered four times a day, while both Restasis and Xiidra are administered twice per day.”
Key opinion leaders (KOLs) interviewed for GlobalData’s report: ‘Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2026’ highlighted that simplified administration frequency is a major unmet need in this market, and reproxalap is not expected to address this. In addition, Allergan and Shire have invested a significant amount into aggressive advertising campaigns for their respective brands, so a company like Aldeyra, which currently does not have a dedicated ophthalmology sales force, marketing team, or even the global reach of these big pharma companies, will be heavily reliant on a future partnership to fully realize the potential of reproxalap in a timely manner.
Lastly, there are other late-stage pipeline drugs for dry eye that will challenge reproxalap’s uptake, namely RegeneRx’s RGN-259, which KOLs viewed to be the strongest pipeline asset for this market.
Musciacco concludes: “Given the numerous market dynamics, reproxalap’s Phase III results and a partnership with an established pharma company will be crucial to establish this new player in the dry eye market.”
* 8MM: US, France, Germany, Italy, Spain, UK, Japan, and China
ENDS
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