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Trial Results of New Drug for An Eye Disease 'Encouraging'
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The data suggest this treatment could be safer and more effective in treating proliferative vitreoretinopathy than compounded methotrexate, noted a Laidlaw & Co. report.

Aldeyra Therapeutics Inc. (ALDX:NASDAQ) announced topline results from the Phase 3 GUARD trial of its drug candidate, ADX-2191, in proliferative vitreoretinopathy, and they were "encouraging," reported Laidlaw & Co. analyst Dr. Yale Jen in an October 6, 2022 research note.

"We view Aldeyra shares as underexposed and undervalued," wrote Jen.



"We view the news very positively as it is a former confirmation of ADX-2191's effect in treating proliferative vitreoretinopathy," Jen wrote.

Considering the news, Laidlaw reiterated its Buy rating and US$30 per share target price on Aldeyra, the current share price of which is about US$5.58. The gap between the two prices implies a significant potential return for investors.

"We view Aldeyra shares as underexposed and undervalued," wrote Jen.

Recap of Results

As for the GUARD Part 1 trial results, the analyst highlighted that they suggest ADX-2191 treatment could be safer and more effective in treating proliferative vitreoretinopathy than compounded methotrexate.

Specifically, in the Phase 3 study, Jen relayed that in the group randomized to ADX-2191, the primary endpoint was met of prevention of retinal detachment over six months (23.5%) with p=0.024, compared to historical control (38.7%). In the group randomized to routine surgical care, retinal detachment over six months was about 29%.

ADX-2191 also showed numerical superiority over routine surgical care in multiple secondary or exploratory endpoints, including visual acuity and central macular subfield thickness. The p-value for dichotomous endpoints, like epiretinal membrane appearance, was 0.047.

In terms of safety, Jen noted ADX-2101 was well tolerated. The most common adverse effect was mild to moderate punctate keratitis, experienced in 16% of patients. This incidence is much less than the 58% previously reported in compounded methotrexate studies.

What to Watch For

Next for Aldeyra and ADX-2191 is a Type C meeting with the U.S. Food and Drug Administration (FDA) in H1/23 to discuss the regulatory path for the use of this drug for proliferative vitreoretinopathy.

In the meantime, however, in Q4/22, the biopharma will meet with the FDA prior to filing a new drug application (NDA) for the same drug candidate for primary vitreoretinal lymphoma.

"A positive [pre-NDA] meeting should lead to an NDA submission soon," Jen wrote.

Also, in Q4/22, Aldeyra expects to file an NDA for reproxalap in dry eye disease.

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Disclosures For Laidlaw & Company, Aldeyra Therapeutics October 6, 2022

Analyst Certification: The analyst responsible for the content of this report hereby certifies that the views expressed regarding the company or companies and their securities accurately represent his personal views and that no direct or indirect compensation is to be received by the analyst for any specific recommendation or views contained in this report. Neither the author of this report nor any member of his immediate family or household maintains a position in the securities mentioned in this report.

Equity Disclosures: For the purpose of ratings distributions, regulatory rules require the firm to assign ratings to one of three rating categories (i.e. Strong Buy/Buy-Overweight, Hold, or Underweight/Sell) regardless of a firm's own rating categories. Although the firm’s ratings of Buy/Overweight, Hold, or Underweight/Sell most closely correspond to Buy, Hold and Sell, respectively, the meanings are not the same because our ratings are determined on a relative basis against the analyst sector universe of stocks.

An analyst's coverage sector is comprised of companies that are engaged in similar business or share similar operating characteristics as the subject company. The analysis sector universe is a sub-sector to the analyst's coverage sector, and is compiled to assist the analyst in determining relative valuations of subject companies. The composition of an analyst's sector universe is subject to change over time as various factors, including changing market conditions occur. Accordingly, the rating assigned to a particular stock represents solely the analyst's view of how that stock will perform over the next 12-months relative to the analyst's sector universe.

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The securities, instruments, or strategies discussed in this report may not be suitable for all investors, and certain investors may not be eligible to purchase or participate in some or all of them. This report is not an offer to buy or sell or the solicitation of an offer to buy or sell any security/instrument or to participate in any particular trading strategy.

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