Aldeyra Therapeutics Inc.'s (ALDX:NASDAQ) reproxalap was shown, via recent clinical trial results, to be effective for dry eye disease, reported H.C. Wainwright & Co. analyst Matthew Caufield in a July 13 research note. These data bode well for the new drug application (NDA) the biotech intends to submit to the U.S. Food and Drug Administration (FDA) for reproxalap, likely in Q3/22.
Reproxalap is a RASP, or reactive aldehyde species, inhibiting 0.25% ophthalmic solution to be administered topically.
"Reproxalap demonstrated robust and consistent dry eye disease benefit," added Caufield. "We view RASP inhibition as presenting a viable novel pathway in addressing current dry eye disease therapeutic limitations."
The approved dry eye disease treatments on the market, noted Caufield, can take months to have an appreciable effect, have inconsistent responses among patients, and can be uncomfortable, often causing patients to stop using them.
Caufield highlighted that the newly released positive data, from the vehicle-controlled crossover reproxalap trial, show the drug met primary and secondary endpoints with statistical significance.
With reproxalap, study participants exhibited improvement in:
1) Dry eye chamber ocular redness, primary endpoint, (p=0.0004). The benefit was observed initially at 10 minutes and then through the final 90 minutes after chamber entry.
2) Schirmer test tear production assessment after one day of dosing, primary endpoint, (p=0.0005). This result supports prior dosing activity and fourth dose activity versus single-day dosing.
3) Schirmer test greater than or equal to 10-millimeter responder analysis, secondary endpoint, (p=0.0361).
Other secondary endpoints reproxalap showed a benefit in were ocular dryness (p=0.0068), discomfort (p<0.0001), grittiness (p=0.0001), stinging (p=0.0001), burning (p<0.0001) and itching (p=0.0003).
These "reflect a broad representation of prospective symptom benefit within a characteristically heterogeneous indication population," wrote Caufield.
Reproxalap also demonstrated a positive safety and tolerability profile. The most common drug-related adverse event was mild, fleeting discomfort at the administration site.
"This most recent data set provides direct RASP inhibition support for the prior TRANQUILITY-2 and TRANQUILITY trials," Caufield commented.
In the next step for its reproxalap program, Aldeyra will meet with the FDA for feedback before submitting the NDA, the most imminent near-term catalyst for the drug developer, according to Caufield.
The analyst also pointed out the FDA does not require all benefits of a prospective dry eye disease drug to be exhibited in one clinical trial. Rather, each benefit must be demonstrated in more than one clinical trial. This is the case with reproxalap, simplifying the approval path for it.
H.C. Wainwright has a Buy rating and a $15 per share price target on Aldeyra, the current share price of which is around $5.06.
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Disclosures for H.C.Wainwright & Co., Aldeyra Therapeutics, July 13, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
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